Trial Outcomes & Findings for Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis (NCT NCT02160626)

NCT ID: NCT02160626

Last Updated: 2019-01-03

Results Overview

Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 172 participants
• Primary outcome timeframe: Baseline, visit 8
• Results posted on: 2019-01-03

Participant Flow

Participant milestones

Measure	A-101 Vehicle A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (40%) Topical Solution A-101 (40%) Topical Solution - high dose A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose	A-101 (32.5%) Topical Solution A-101 (32.5%) Topical Solution - low dose A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose
Overall Study STARTED	58	57	57
Overall Study COMPLETED	57	56	56
Overall Study NOT COMPLETED	1	1	1

Reasons for withdrawal

Measure	A-101 Vehicle A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (40%) Topical Solution A-101 (40%) Topical Solution - high dose A-101 (40) Topical Solution: A-101 (40) Topical Solution - high dose	A-101 (32.5%) Topical Solution A-101 (32.5%) Topical Solution - low dose A-101 (32.5) Topical Solution: A-101 (32.5) Topical Solution - low dose
Overall Study Adverse Event	1	0	0
Overall Study Schedule not conducive to study visits	0	0	1
Overall Study Withdrawal by Subject	0	1	0

Baseline Characteristics

Dose-Response Profile of A-101 in Subjects With Seborrheic Keratosis

Baseline characteristics by cohort

Measure	A-101 Vehicle n=58 Participants A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (40%) Topical Solution n=57 Participants A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose	A-101 (32.5%) Topical Solution n=57 Participants A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose	Total n=172 Participants Total of all reporting groups
Age, Customized 18-55	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Customized 56-70	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Age, Customized 71 +	56 Participants n=5 Participants	56 Participants n=7 Participants	57 Participants n=5 Participants	169 Participants n=4 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	33 Participants n=7 Participants	28 Participants n=5 Participants	91 Participants n=4 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	24 Participants n=7 Participants	29 Participants n=5 Participants	81 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	57 Participants n=5 Participants	57 Participants n=7 Participants	57 Participants n=5 Participants	171 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	58 Participants n=5 Participants	56 Participants n=7 Participants	57 Participants n=5 Participants	171 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	58 participants n=5 Participants	57 participants n=7 Participants	57 participants n=5 Participants	172 participants n=4 Participants
Fitzpatrick skin type 1	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants
Fitzpatrick skin type 2	13 Participants n=5 Participants	27 Participants n=7 Participants	24 Participants n=5 Participants	64 Participants n=4 Participants
Fitzpatrick skin type 3	30 Participants n=5 Participants	19 Participants n=7 Participants	20 Participants n=5 Participants	69 Participants n=4 Participants
Fitzpatrick skin type 4	11 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	27 Participants n=4 Participants
Fitzpatrick skin type 5	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Fitzpatrick skin type 6	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, visit 8

Population: Overall number of participants = number of participants completing the study per protocol.

Mean of per-subject percentages of target lesions judged to be clear on the PLA (PLA = 0) at end of study (Visit 8). The PLA is a four point scale from 0 being clear to 3 being most severe lesion.

Outcome measures

Measure	A-101 Vehicle n=228 Lesions A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (32.5%) Topical Solution n=224 Lesions A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose	A-101 (40%) Topical Solution n=224 Lesions A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose
Mean Per Subject Percentage Target Lesions Judged Clear by the Physician's Lesion Assessment (PLA)	4.82 percentage of lesions cleared Standard Deviation 15.26	26.79 percentage of lesions cleared Standard Deviation 38.10	45.09 percentage of lesions cleared Standard Deviation 37.06

SECONDARY outcome

Timeframe: Baseline, visit 8

Population: N = number of participants completing the protocol.

Change from baseline PLA will be calculated for each lesion first, then per-subject mean changes from baseline will be calculated.

The PLA is a score on a four scale from 0 to 3 with 0 being clear and 3 being the most severe, a lower score indicating a better result. For the mean change in this score, a larger mean change is a better result.

Outcome measures

Measure	A-101 Vehicle n=228 Lesions A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (32.5%) Topical Solution n=224 Lesions A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose	A-101 (40%) Topical Solution n=224 Lesions A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose
Mean Change From Baseline to Visit 8 in the Physician's Lesion Assessment	-0.32 units on a scale Standard Deviation 0.57	-0.77 units on a scale Standard Deviation 0.67	-0.91 units on a scale Standard Deviation 0.77

SECONDARY outcome

Timeframe: Baseline, visit 8

Population: N = number of subjects who completed the study per protocol.

Proportion of Subjects who had at least 3 of 4 target lesions judged to be clear on the Physician Lesion Assessment (PLA =0) at visit 8. The PLA is a 4 point scale evaluating the severity of a lesion with 0 being clear and 3 being the most severe.

Outcome measures

Measure	A-101 Vehicle n=57 Participants A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (32.5%) Topical Solution n=56 Participants A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose	A-101 (40%) Topical Solution n=56 Participants A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose
Proportion of Subjects Who Had at Least 3 of 4 Target Lesions Judged to be Clear on the Physician Lesion Assessment (PLA =0) at Visit 8.	0 Participants	9 Participants	11 Participants

Adverse Events

A-101 Vehicle

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

A-101 (32.5%) Topical Solution

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

A-101 (40%) Topical Solution

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	A-101 Vehicle n=58 participants at risk A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (32.5%) Topical Solution n=57 participants at risk A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose	A-101 (40%) Topical Solution n=57 participants at risk A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Cardiac disorders Atrial Fibrillation	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Injury, poisoning and procedural complications Laceration	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.

Other adverse events

Measure	A-101 Vehicle n=58 participants at risk A-101 Vehicle (placebo) Topical Solution A-101 Vehicle: Placebo control	A-101 (32.5%) Topical Solution n=57 participants at risk A-101 (32.5%) Topical Solution - low dose A-101 (32.5%) Topical Solution: A-101 (32.5%) Topical Solution - low dose	A-101 (40%) Topical Solution n=57 participants at risk A-101 (40%) Topical Solution - high dose A-101 (40%) Topical Solution: A-101 (40%) Topical Solution - high dose
Gastrointestinal disorders Constipation	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Gastrointestinal disorders Diarrhoea	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Gastrointestinal disorders Toothache	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	3.5% 2/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
General disorders Axillary Pain	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
General disorders Pain	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	3.5% 2/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Immune system disorders Rhinitis allergic	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Immune system disorders Seasonal allergy	3.4% 2/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Bronchitis	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Cystitis	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Ear infection	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Nasopharyngitis	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	3.5% 2/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Sinusitis	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Tinea Cruris	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Tooth infection	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Upper respiratory tract infection	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	3.5% 2/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Viral upper respiratory infection	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Injury, poisoning and procedural complications Arthropod sting	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Injury, poisoning and procedural complications Excoriation	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Injury, poisoning and procedural complications Fall	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Investigations Blood glucose increase	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Investigations Glycosylated haemoglobin increased	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Metabolism and nutrition disorders Oedema Peripheral	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Musculoskeletal and connective tissue disorders Arthritis	6.9% 4/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Musculoskeletal and connective tissue disorders Back pain	3.4% 2/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	3.5% 2/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Musculoskeletal and connective tissue disorders Ligament sprain	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Musculoskeletal and connective tissue disorders Pain in extremity	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Musculoskeletal and connective tissue disorders Pain in Jaw	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Head and neck cancer	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Nervous system disorders Headache	3.4% 2/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Nervous system disorders Insomnia	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Psychiatric disorders Dementia	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Renal and urinary disorders Nephrolithiasis	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Renal and urinary disorders Urinary tract infection	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	3.5% 2/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Skin and subcutaneous tissue disorders Blepharitis	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Skin and subcutaneous tissue disorders Contusion	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Skin and subcutaneous tissue disorders Sunburn	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Surgical and medical procedures Acrochordon excision	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Surgical and medical procedures Cyst removal	1.7% 1/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Surgical and medical procedures Injection	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Surgical and medical procedures Skin neoplasm excision	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.
Vascular disorders Migraine	0.00% 0/58 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	1.8% 1/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.	0.00% 0/57 • From subject's first study medication application to the end of the study (visit 8), up to 106 days. the end of the subject's last visit. 106. An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and which does not necessarily have a causal relationship with the study medication. Thus any new, clinically relevant worsening of an existing sign, symptom or disease, should be considered an AE.

Additional Information

Judith Schnyder

Aclaris Therapeutics Inc.

Phone: +1-484-329-2144

Email: jschnyder@aclaristx.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Institution and investigators agree to not publish the results of this study without the permission of the sponsor.
• Publication restrictions are in place

Restriction type: OTHER