Trial Outcomes & Findings for Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis (NCT NCT01986920)

NCT ID: NCT01986920

Last Updated: 2018-12-11

Results Overview

Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion. The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: Visit 2 to visit 9 (78 days)
• Results posted on: 2018-12-11

Participant Flow

In this study each patient is treated with all 4 treatments on 4 different lesions on their back. Therefore, each patient participates in each group so the total enrollment matches the number of lesions treated but not the total participants.

Unit of analysis: lesions

Participant milestones

Measure	A-101 25% Low dose group A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 32.5% Mid Dose Group A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 40% High Dose Group A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions	A-101 Vehicle Placebo group A-101 Vehicle: Placebo applied to one of 4 Target Lesions
A- 101 25% STARTED	35 35	0 0	0 0	0 0
A- 101 25% COMPLETED	34 34	0 0	0 0	0 0
A- 101 25% NOT COMPLETED	1 1	0 0	0 0	0 0
A-101 32.5% STARTED	0 0	35 35	0 0	0 0
A-101 32.5% COMPLETED	0 0	34 34	0 0	0 0
A-101 32.5% NOT COMPLETED	0 0	1 1	0 0	0 0
A-101 40% STARTED	0 0	0 0	35 35	0 0
A-101 40% COMPLETED	0 0	0 0	34 34	0 0
A-101 40% NOT COMPLETED	0 0	0 0	1 1	0 0
Placebo STARTED	0 0	0 0	0 0	35 35
Placebo COMPLETED	0 0	0 0	0 0	34 34
Placebo NOT COMPLETED	0 0	0 0	0 0	1 1

Reasons for withdrawal

Measure	A-101 25% Low dose group A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 32.5% Mid Dose Group A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 40% High Dose Group A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions	A-101 Vehicle Placebo group A-101 Vehicle: Placebo applied to one of 4 Target Lesions
A- 101 25% Withdrawal by Subject	1	0	0	0
A-101 32.5% Withdrawal by Subject	0	1	0	0
A-101 40% Withdrawal by Subject	0	0	1	0
Placebo Withdrawal by Subject	0	0	0	1

Baseline Characteristics

Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

Baseline characteristics by cohort

Measure	Entire Study Population n=35 Participants Subjects were required to have 4 Target Seborrheic Keratosis Lesions their back. Each lesion was treated with one of the four treatment interventions (A-101 Solution 25%, A-101, Solution 32.5%, A-101 Solution 40% and the A-101 Solution Vehicle) in a randomized fashion.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=93 Participants
Age, Categorical >=65 years	29 Participants n=93 Participants
Age, Continuous	69.43 Years STANDARD_DEVIATION 6.52 • n=93 Participants
Sex: Female, Male Female	20 Participants n=93 Participants
Sex: Female, Male Male	15 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	35 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	35 Participants n=93 Participants

PRIMARY outcome

Timeframe: Visit 2 to visit 9 (78 days)

Population: A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.

Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion.

The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.

Outcome measures

Measure	A-101 25% n=34 Participants Low dose group A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 32.5% n=34 Participants Mid Dose Group A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 40% n=34 Participants High Dose Group A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions	A-101 Vehicle n=34 Participants Placebo group A-101 Vehicle: Placebo applied to one of 4 Target Lesions
Mean Change in Physician Lesion Assessment Scale	-0.47 Change in Score on a scale Standard Deviation 0.66	-0.88 Change in Score on a scale Standard Deviation 0.73	-1.12 Change in Score on a scale Standard Deviation 0.81	-0.15 Change in Score on a scale Standard Deviation 0.36

SECONDARY outcome

Timeframe: Visit 9 (Day 78)

Population: A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.

Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).

Outcome measures

Measure	A-101 25% n=34 Participants Low dose group A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 32.5% n=34 Participants Mid Dose Group A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 40% n=34 Participants High Dose Group A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions	A-101 Vehicle n=34 Participants Placebo group A-101 Vehicle: Placebo applied to one of 4 Target Lesions
Subject's Self Assessment Scale Clear	7 Participants	09 Participants	08 Participants	01 Participants
Subject's Self Assessment Scale Mild	12 Participants	09 Participants	13 Participants	13 Participants
Subject's Self Assessment Scale Moderate	13 Participants	12 Participants	11 Participants	18 Participants
Subject's Self Assessment Scale Severe	02 Participants	04 Participants	02 Participants	02 Participants

Adverse Events

A-101 25%

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

A-101 32.5%

Serious events: 1 serious events

Other events: 21 other events

Deaths: 0 deaths

A-101 40%

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

A-101 Vehicle

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	A-101 25% n=35 participants at risk Low dose group A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 32.5% n=35 participants at risk Mid Dose Group A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 40% n=35 participants at risk High Dose Group A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions	A-101 Vehicle n=35 participants at risk Placebo group A-101 Vehicle: Placebo applied to one of 4 Target Lesions
Renal and urinary disorders Acute Pyelonephritis	2.9% 1/35 • Number of events 1 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Number of events 1 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Number of events 1 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Number of events 1 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.

Other adverse events

Measure	A-101 25% n=35 participants at risk Low dose group A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 32.5% n=35 participants at risk Mid Dose Group A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions	A-101 40% n=35 participants at risk High Dose Group A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions	A-101 Vehicle n=35 participants at risk Placebo group A-101 Vehicle: Placebo applied to one of 4 Target Lesions
Skin and subcutaneous tissue disorders Crusting	17.1% 6/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	34.3% 12/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	42.9% 15/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Skin and subcutaneous tissue disorders Erythema	22.9% 8/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	48.6% 17/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	54.3% 19/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Skin and subcutaneous tissue disorders Hypopigmentation	5.7% 2/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Skin and subcutaneous tissue disorders Induration	8.6% 3/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	11.4% 4/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Skin and subcutaneous tissue disorders Scaling	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	14.3% 5/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Skin and subcutaneous tissue disorders Stinging	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	0.00% 0/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Gastrointestinal disorders Abdominal Pain Upper	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Gastrointestinal disorders Diarrhoea	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Gastrointestinal disorders Toothache	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Immune system disorders Seasonal allergy	28.6% 10/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	28.6% 10/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	28.6% 10/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	28.6% 10/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Injury, poisoning and procedural complications Wound	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Musculoskeletal and connective tissue disorders Arthritis	11.4% 4/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	11.4% 4/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	11.4% 4/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	11.4% 4/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Musculoskeletal and connective tissue disorders Spinal column stenosis	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Nervous system disorders Dementia Alzheimer's type	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Nervous system disorders Insomnia	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Psychiatric disorders Depression	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Renal and urinary disorders Cystitis	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.	2.9% 1/35 • Serious adverse events were collected from the time the subject signed the informed consent until the subject's last visit. Adverse events were collected from the time immediately after the first application of the study medication until the subject's last visit.

Additional Information

Christopher Powala, Chief Operating Officer

Aclaris Therapeutics

Phone: 484-324-7933

Email: cpowala@aclaristx.com

Results disclosure agreements

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

Restriction type: OTHER