Trial Outcomes & Findings for Oracea Soolantra Association in Participants With Severe Rosacea (NCT NCT03075891)

Results Overview

Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is \[i.e.\] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

273 participants

Primary outcome timeframe

Baseline, Week 12

Results posted on

2021-03-16

Participant Flow

This study was conducted at 39 sites in Canada, Czech Republic, Germany, Hungary, Poland, and United States of America between 05 July 2017 to 08 February 2018.

A total of 273 participants were randomized and treated, out of which 251 participants completed the study.

Participant milestones

Participant milestones
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% (percent) cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg (milligram) Modified Release (MR) (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Overall Study STARTED	135	138
Overall Study COMPLETED	126	125
Overall Study NOT COMPLETED	9	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules Ivermectin 1% (percent) cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg (milligram) Modified Release (MR) (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Overall Study Withdrawal by Subject	3	6
Overall Study Lost to Follow-up	1	0
Overall Study Pregnancy	3	1
Overall Study visits not performed (no time)	1	0
Overall Study Drug abuse relapse issue	0	1
Overall Study Participant requiring study withdrawal	0	1
Overall Study Adverse event, non-fatal	1	4

Baseline Characteristics

Oracea Soolantra Association in Participants With Severe Rosacea

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.	Total n=273 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	109 Participants n=5 Participants	110 Participants n=7 Participants	219 Participants n=5 Participants
Age, Categorical >=65 years	26 Participants n=5 Participants	28 Participants n=7 Participants	54 Participants n=5 Participants
Age, Continuous	52.4 years STANDARD_DEVIATION 13.5 • n=5 Participants	51.6 years STANDARD_DEVIATION 13.3 • n=7 Participants	52 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants	80 Participants n=7 Participants	155 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	58 Participants n=7 Participants	118 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	133 Participants n=5 Participants	136 Participants n=7 Participants	269 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Skin phototype Skin phototype I	5 Participants n=5 Participants	11 Participants n=7 Participants	16 Participants n=5 Participants
Skin phototype Skin phototype II	82 Participants n=5 Participants	83 Participants n=7 Participants	165 Participants n=5 Participants
Skin phototype Skin phototype III	37 Participants n=5 Participants	38 Participants n=7 Participants	75 Participants n=5 Participants
Skin phototype Skin phototype IV	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Skin phototype Skin phototype V	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Skin phototype Skin phototype VI	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 12

Population: Intent-to-treat (ITT) population consisted of the entire population enrolled and randomized. The last observation carried forward (LOCF) method was used to impute missing values for inflammatory lesion count.

Percent change from baseline in inflammatory lesion count at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (that is \[i.e.\] papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter (cm) in diameter; and Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percent Change From Baseline in Inflammatory Lesion Count at Week 12	-80.29 percent change Standard Deviation 21.65	-73.56 percent change Standard Deviation 30.52

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 8

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.

Percent change from baseline in inflammatory lesion count at Weeks 4 and 8 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 Week 4	-48.15 percent change Standard Deviation 26.71	-39.27 percent change Standard Deviation 27.93
Percent Change From Baseline in Inflammatory Lesion Count at Weeks 4 and 8 Week 8	-69.14 percent change Standard Deviation 24.10	-61.44 percent change Standard Deviation 28.74

SECONDARY outcome

Timeframe: Week 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.

Percentage of participants with clear inflammatory lesions at week 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 cm in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants With Clear Inflammatory Lesions at Week 12	17.8 percentage of participants	7.2 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.

Percentage of participants with 100% reduction in inflammatory lesions at Weeks 4, 8 and 12 was reported. Inflammatory lesions included facial inflammatory lesions of rosacea (i.e. papules and pustules) which were defined as follows: Papule - a small, solid elevation less than 1.0 centimeter in diameter. Pustule - a small, circumscribed elevation of the skin, which contains yellow white exudates. Papules and pustules were counted separately on each of the 5 facial regions (forehead, chin, nose, right cheek and left cheek). Notably, nodules (i.e. circumscribed, elevated, solid lesions more than 1.0 cm in diameter with palpable depth) were not included in the count of inflammatory lesions.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 Week 4: Yes	1.5 percentage of participants	0.0 percentage of participants
Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 Week 4: No	98.5 percentage of participants	100.0 percentage of participants
Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 Week 8: Yes	5.2 percentage of participants	2.9 percentage of participants
Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 Week 8: No	94.8 percentage of participants	97.1 percentage of participants
Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 Week 12: Yes	17.8 percentage of participants	7.2 percentage of participants
Percentage of Participants With 100 Percent (%) Reduction in Inflammatory Lesions at Weeks 4, 8 and 12 Week 12: No	82.2 percentage of participants	92.8 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.

The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 Week 4	2.47 Units on a scale Standard Deviation 0.94	2.56 Units on a scale Standard Deviation 0.94
Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 Week 8	1.85 Units on a scale Standard Deviation 0.95	1.97 Units on a scale Standard Deviation 0.94
Clinician's Erythema Assessment (CEA) Total Score at Weeks 4, 8 and 12 Week 12	1.51 Units on a scale Standard Deviation 1.02	1.58 Units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.

The evaluator assessed the participant's diffuse persistent facial erythema of rosacea by performing a static ("snap shot") evaluation of erythema severity at a social distance of approximately 50 centimeter (cm) using CEA scale, at each visit. CEA is a 5 point scale where 0 = clear (clear skin with no signs of erythema); 1 = almost clear (almost clear; slight redness); 2 = mild (mild erythema; definite redness); 3 = moderate (moderate erythema; marked redness); 4 = severe (severe erythema; fiery redness). A higher score than baseline indicates a worse outcome.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 4 (0= Clear skin)	0.7 percentage of participants	0.7 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 4 (1= Almost clear)	16.3 percentage of participants	12.3 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 4 (2= Mild erythema)	31.9 percentage of participants	34.1 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 4 (3= Moderate erythema)	37.8 percentage of participants	36.2 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 4 (4= Severe erythema)	13.3 percentage of participants	16.7 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 8 (0= Clear skin)	5.2 percentage of participants	1.4 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 8 (1= Almost clear)	31.1 percentage of participants	33.3 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 8 (2= Mild erythema)	43.7 percentage of participants	39.1 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 8 (3= Moderate erythema)	13.3 percentage of participants	18.8 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 8 (4= Severe erythema)	6.7 percentage of participants	7.2 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 12 (0= Clear skin)	14.1 percentage of participants	7.2 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 12 (1= Almost clear)	41.5 percentage of participants	47.8 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 12 (2= Mild erythema)	28.1 percentage of participants	29.7 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 12 (3= Moderate erythema)	11.9 percentage of participants	10.1 percentage of participants
Percentage of Participants in Each Clinician's Erythema Assessment Score Category at Weeks 4, 8 and 12 Week 12 (4= Severe erythema)	4.4 percentage of participants	5.1 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.

The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema).

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 Week 4	2.59 Units on a scale Standard Deviation 0.88	2.84 Units on a scale Standard Deviation 0.83
Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 Week 8	1.78 Units on a scale Standard Deviation 0.83	2.04 Units on a scale Standard Deviation 0.93
Investigator's Global Assessment (IGA) Total Score at Weeks 4, 8 and 12 Week 12	1.34 Units on a scale Standard Deviation 0.89	1.57 Units on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values for inflammatory lesion count.

The evaluator assessed the participant's rosacea by performing a static ("snap shot") evaluation, at a social distance of approximately 50 cm, using the IGA score. IGA is a 5 point scale where, 0 = clear (no inflammatory lesions present, no erythema); 1 = almost clear (very small papules/pustules, very mild erythema present); 2 = mild (few small papules/pustules, mild erythema); 3 = moderate (severe small or large papules/pustules, moderate erythema); 4 = severe (numerous small and/or large papules/pustules, severe erythema).

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 4 (0 - Clear)	1.5 percentage of participants	0.7 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 4 (1 - Almost clear)	11.1 percentage of participants	5.1 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 4 (2- Mild)	25.2 percentage of participants	23.9 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 4 (3 - Moderate)	51.9 percentage of participants	50.0 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 4 (4 - Severe)	10.4 percentage of participants	20.3 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 8 (0 - Clear)	3.0 percentage of participants	3.6 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 8 (1 - Almost clear)	34.8 percentage of participants	22.5 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 8 (2 - Mild)	48.1 percentage of participants	47.8 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 8 (3 - Moderate)	9.6 percentage of participants	18.1 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 8 (4 - Severe)	4.4 percentage of participants	8.0 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 12 (0 - Clear)	11.9 percentage of participants	5.1 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 12 (1 - Almost clear)	54.8 percentage of participants	54.3 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 12 (2 - Mild)	24.4 percentage of participants	26.1 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 12 (3 - Moderate)	5.2 percentage of participants	8.0 percentage of participants
Percentage of Participants in Each Investigator's Global Assessment Score Category at Weeks 4, 8 and 12 Week 12 (4 - Severe)	3.7 percentage of participants	6.5 percentage of participants

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.

The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort).

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Stinging/Burning Severity Score at Weeks 4, 8 and 12 Week 4	0.73 units on a scale Standard Deviation 0.79	0.65 units on a scale Standard Deviation 0.75
Stinging/Burning Severity Score at Weeks 4, 8 and 12 Week 8	0.41 units on a scale Standard Deviation 0.64	0.44 units on a scale Standard Deviation 0.67
Stinging/Burning Severity Score at Weeks 4, 8 and 12 Week 12	0.31 units on a scale Standard Deviation 0.55	0.33 units on a scale Standard Deviation 0.63

SECONDARY outcome

Timeframe: Weeks 4, 8 and 12

Population: ITT population consisted of the entire population enrolled and randomized. The LOCF method was used to impute missing values.

The evaluator recorded the severity of the participant's facial stinging/burning sensation during the last 24 hours according to the stinging/burning scale. Stinging/burning scale is a 4 point scale where, 0 = none (No stinging/burning ); 1 = mild (slight warm, tingling/stinging sensation, not really bothersome); 2 = moderate (definite warm, tingling/stinging sensation that is somewhat bothersome); 3 = severe (hot, tingling/stinging sensation that has caused definite discomfort).

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 12 (1 - Mild)	22.2 percentage of participants	17.4 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 12 (2 - Moderate)	4.4 percentage of participants	6.5 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 4 (0 - None)	47.4 percentage of participants	50.0 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 4 (1 - Mild)	32.6 percentage of participants	36.2 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 4 (2 - Moderate)	19.3 percentage of participants	12.3 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 4 (3 - Severe)	0.7 percentage of participants	1.4 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 8 (0 - None)	67.4 percentage of participants	64.5 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 8 (1 - Mild)	24.4 percentage of participants	28.3 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 8 (2 - Moderate)	8.1 percentage of participants	5.8 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 8 (3 - Severe)	0.0 percentage of participants	1.4 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 12 (0 - None)	73.3 percentage of participants	75.4 percentage of participants
Percentage of Participants in Each Stinging/Burning Severity Score Category at Weeks 4, 8 and 12 Week 12 (3 - Severe)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 12 (last visit/early termination)

Population: ITT population consisted of the entire population enrolled and randomized. Here the over all number of participants analyzed signifies participants who were evaluable for this outcome measure.

Participants were evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. It is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved \[100% improvement\]); 1=excellent improvement (nearly all signs and symptoms cleared \[90% improvement\]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved \[about 75% improvement\]); 3=good improvement (significant improvement, but many signs and symptoms remain \[about 50% improvement\]); 4=minimal improvement (slight overall improvement, but not clinically significant \[about 25% improvement\]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline).

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=126 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Global Improvement Total Score at Week 12 (Last Visit/Early Termination)	1.79 units on a scale Standard Deviation 1.20	1.81 units on a scale Standard Deviation 1.20

SECONDARY outcome

Timeframe: Week 12 (last visit/early termination)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Participants were to evaluated for his/her improvement in rosacea compared to his/her rosacea condition before study, using global Improvement scale. it is a 7 item scale where, 0=complete improvement (all signs and symptoms of disease have resolved \[100% improvement\]); 1=excellent improvement (nearly all signs and symptoms cleared \[90% improvement\]. Only minimal residual signs and symptoms remain); 2=very good improvement (majority of the signs and symptoms have resolved \[about 75% improvement\]); 3=good improvement (significant improvement, but many signs and symptoms remain \[about 50% improvement\]); 4=minimal improvement (slight overall improvement, but not clinically significant \[about 25% improvement\]); 5=no change (overall severity similar to baseline); 6=worse (worse than baseline). .

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=126 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) 0 - Complete improvement	7.9 percentage of participants	6.2 percentage of participants
Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) 1 - Excellent improvement	39.7 percentage of participants	44.2 percentage of participants
Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) 2 - Very good improvement	31.7 percentage of participants	25.6 percentage of participants
Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) 3 - Good improvement	11.9 percentage of participants	15.5 percentage of participants
Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) 4 - Minimal improvement	4.0 percentage of participants	3.9 percentage of participants
Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) 5 - No change	4.0 percentage of participants	3.9 percentage of participants
Percentage of Participants in Each Global Improvement Score Category at Week 12 (Last Visit/Early Termination) 6 - Worse	0.8 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: From the signing of the informed consent form (ICF) up to Week 12

Population: Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily had a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A SAE was any untoward medical occurrence that at any dose: results in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or was a congenital anomaly/birth defect.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	27 Participants	50 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Week 12 (last visit/early termination)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=125 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Dermatology Life Quality Index (DLQI) Questionnaire Total Score at Week 12 (Last Visit/Early Termination Visit)	1.4 units on a scale Standard Deviation 2.2	2.2 units on a scale Standard Deviation 4.0

SECONDARY outcome

Timeframe: Baseline, Week 12 (last visit/early termination)

Population: ITT population consisted of the entire population enrolled and randomized. Here, n, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

Impact of study treatments on subjects' quality of life was measured by using DLQI questionnaire. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of-life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0- 3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Baseline: 0-1	17.8 percentage of participants	18.8 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Baseline: 2-5	37.8 percentage of participants	33.3 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Baseline: 6-10	27.4 percentage of participants	32.6 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Baseline: 11-20	14.8 percentage of participants	12.3 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Baseline: 21-30	2.2 percentage of participants	2.9 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Week 12: 0-1	68.0 percentage of participants	65.1 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Week 12: 2-5	26.4 percentage of participants	24.0 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Week 12: 6-10	4.8 percentage of participants	7.0 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Week 12: 11-20	0.8 percentage of participants	3.1 percentage of participants
Percentage of Participants in Each Dermatology Life Quality Index (DLQI) Questionnaire Score Category Week 12: 21-30	0.0 percentage of participants	0.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 12 (last visit/early termination)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Percent Change from Baseline in Dermatology Life Quality Index questionnaire Total Score at Last Visit. DLQI focuses on impact of dermatological diseases on quality of life. It is a 10-item validated quality-of life questionnaire specific to dermatological conditions. 1) how itchy, sore, painful, stinging?, 2) how embarrassed/self-conscious?, 3) interfere shopping or looking after home or garden?, 4) Influence clothes?, 5) affect social/leisure activity?, 6) difficult to do sport?, 7) prevent from working/studying? or If no, problem at work/studying?, 8) problem with partner or close friend?, 9) cause sexual difficulties?, 10) problem caused by treatment?. Total score ranged from 0-30 (each question had a score range of 0-3) where, 0-1=no effect at all on life; 2-5=small effect on life; 6-10=moderate effect on life; 11- 20=very large effect on life; 21-30=extremely large effect on life. A higher score indicates a low quality of life due to more severe disease.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=120 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=126 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percent Change From Baseline in Dermatology Life Quality Index Questionnaire Total Score at Week 12 (Last Visit/Early Termination)	-59.5 Percent Change Standard Deviation 66.3	-59.2 Percent Change Standard Deviation 70.6

SECONDARY outcome

Timeframe: Week 12/Last visit or early termination visit

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=125 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
EuroQol-5 Dimension-5 Level (EQ-5D-5L) Questionnaire at Week 12 (Last Visit/Early Termination Visit)	83.5 units on a scale Standard Deviation 16.2	83.0 units on a scale Standard Deviation 15.1

SECONDARY outcome

Timeframe: Baseline, Week 12 (last visit/early termination)

Population: ITT population consisted of the entire population enrolled and randomized. Here, n, number of participants analyzed refer to the number of participants evaluable for this outcome at specified time point.

EQ-5D-5L is a 5-level, 5-dimensional format standardized instrument for use as a measure of health outcome used to assess the impact of study treatments on participants quality of life as follows: 1) mobility; 2) self-care; 3) usual activities; 4) pain/discomfort; 5) anxiety/depression. Each dimension comprised of 5 levels with corresponding numeric scores, where 1 indicated no problems, and 5 indicated extreme problems. Participant selected answer for each of 5 dimensions considering response that best matches his/her health today with anchors ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). An increase in the EQ-5D-5L total score indicates improvement.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=138 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Baseline: Mobility	80 percentage of participants	84.1 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Baseline: Self-care	96.3 percentage of participants	97.8 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Baseline: Usual activities	85.9 percentage of participants	89.1 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Baseline: Pain/discomfort	55.6 percentage of participants	57.2 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Baseline: Anxiety/depression	65.9 percentage of participants	69.6 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Week 12: Mobility	80.0 percentage of participants	83.7 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Week 12: Self-care	94.4 percentage of participants	96.9 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Week 12: Usual activities	89.6 percentage of participants	90.7 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Week 12: Pain/discomfort	68.0 percentage of participants	79.1 percentage of participants
Percentage of Participants in Each EuroQol-5 Dimension-5 Level Questionnaire Questions Who Reported No Problems at Baseline and Week 12 (Last Visit/Early Termination) Week 12: Anxiety/depression	77.6 percentage of participants	82.2 percentage of participants

SECONDARY outcome

Timeframe: Week 12 (Last visit/early termination visit)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

WPAI:GH questionnaire was an instrument to measure impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement. Currently Employed question was assessed in this outcome measure.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=125 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=128 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit) No	34.1 percentage of participants	34.8 percentage of participants
Percentage of Participants Reported Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire for Currently Employed Question at Week 12 (Last Visit/Early Termination Visit) Yes	65.9 percentage of participants	65.2 percentage of participants

SECONDARY outcome

Timeframe: Week 12 (Last visit/Early termination visit)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week including questions: missed hours from work because of rosacea?, missed hours from work because of other reason?, number of Working hours. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicate little or no impact of health problems on work and activities, and a negative change in the WPAI score indicates improvement.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=80 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=82 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12 Missed hours from work because of rosacea	0.1 hours Standard Deviation 0.9	0.0 hours Standard Deviation 0.0
Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12 Missed hours from work because of other reason	4.2 hours Standard Deviation 10.9	2.9 hours Standard Deviation 9.6
Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire - Hours Missed at Work, Impact to Productivity at Work and Daily Activities at Week 12 Number of Working hours	36.3 hours Standard Deviation 17.7	38.2 hours Standard Deviation 14.8

SECONDARY outcome

Timeframe: Week 12 (Last visit/Early termination visit)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

WPAI:GH questionnaire is an instrument to measure impairment in both paid and unpaid work during the past week, on a scale ranging from 0 (health problems had no effect) to 10 (health problems completely prevented them from working) including questions: 5) how much rosacea affect productivity at work?; 6) how much rosacea affect daily activity?. It measures absenteeism, presenteeism as well as the impairments in unpaid activity because of health problem during the past seven days. Low scores indicated little or no impact of health problems on work and activities, and a negative change in the WPAI score indicated improvement."

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=125 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=128 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit) How much rosacea affect productivity at work	0.6 units on a scale Standard Deviation 1.5	0.5 units on a scale Standard Deviation 1.2
Work Productivity and Activity Impairment: General Health (WPAI:GH) Questionnaire (How Much Rosacea Affect Productivity at Work, How Much Rosacea Affect Daily Activity) at Week 12 (Last Visit/Early Termination Visit) How much rosacea affect daily activity	0.5 units on a scale Standard Deviation 1.3	0.7 units on a scale Standard Deviation 1.5

SECONDARY outcome

Timeframe: Week 12 (Last visit/early termination visit)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Subject's satisfaction questionnaire was used to specifically collect the subjects' feedback on the treatment regimen, the level of satisfaction and future usage. Questionnaire consisted of 4 parts: Part A, B, C and D. where Part A consisted of following 12 questions about study drugs (capsules and cream): 1-Time the study regimen took to work, 2-Improvement of facial lesions, 3-Improvement of facial redness, 4-Improvement of ocular symptoms, 5-Improvement of flushing episodes, 6-How bothered by side effects, 7-Your face looks, 8-You feel, 9-Easy to incorporate in daily routine, 10-Using the study regimen again, 11-Overall satisfaction, 12-Compared to last treatment. Satisfied score of questionnaire meant as participants responded as Very satisfied (Questions-1,2,3,4,5,11), Not bothered at all (Question-6), A lot better (Questions- 7,8,12), yes (Question-10), strongly agree (Question-9).

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=125 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 1.Time the study regimen took to work	48.0 percentage of participants	45.0 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 2.Improvement of facial lesions	48.0 percentage of participants	46.5 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 3.Improvement of facial redness	45.6 percentage of participants	41.1 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 4.Improvement of ocular symptoms	25.6 percentage of participants	26.4 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 5.Improvement of flushing episodes	41.6 percentage of participants	38.0 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 6.How bothered by side effects	84.0 percentage of participants	76.7 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 7.Your face looks	70.4 percentage of participants	65.9 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 8.You feel	61.6 percentage of participants	55.0 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 9.Easy to incorporate in daily routine	62.4 percentage of participants	58.9 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 10.Using the study regimen again	86.4 percentage of participants	82.9 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 11.Overall satisfaction	54.4 percentage of participants	52.7 percentage of participants
Percentage of Participants Who Reported Satisfied for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part A 12.Compared to last treatment	42.4 percentage of participants	41.1 percentage of participants

SECONDARY outcome

Timeframe: Week 12 (Last visit/early termination visit)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Part B of Questionnaire consisted of following 10 questions about both provided skin care products cleanser and moisturizer: 1-Easy to incorporate into a daily routine, 2-Recommend to my family or friends, 3-Help my skin look healthier, 4-More confident with rosacea, 5-More confident with skin appearance, 6-Positive difference in the appearance, 7-Keep using both skin care products, 8-Make my skin more hydrated, 9-Improve the texture of my skin, 10-Pleasant to use.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=124 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 1.Easy to incorporate into a daily routine	68.5 percentage of participants	70.5 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 2.Recommend to my family or friends	60.5 percentage of participants	52.7 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 3.Help my skin look healthier	58.1 percentage of participants	50.4 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 4.More confident with rosacea	33.1 percentage of participants	32.6 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 5.More confident with skin appearance	37.9 percentage of participants	36.4 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 6.Positive difference in the appearance	47.6 percentage of participants	44.2 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 7.Keep using both skin care products	52.4 percentage of participants	48.8 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 8.Make my skin more hydrated	42.7 percentage of participants	38.8 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 9.Improve the texture of my skin	35.5 percentage of participants	34.9 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part B 10.Pleasant to use	54.0 percentage of participants	50.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12 (Last visit or early termination visit)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Part C subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product cleanser: 1-Clean healthy skin feeling, 2-Deep cleansing without stripping moisture, 3-Rinsed off easily, 4-Not make my skin feel tight or dry.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=124 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C 1.Clean healthy skin feeling	49.2 percentage of participants	46.5 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C 2.Deep cleansing without stripping moisture	41.1 percentage of participants	40.3 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C 3.Rinsed off easily	54.0 percentage of participants	48.8 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part C 4.Not make my skin feel tight or dry	59.7 percentage of participants	50.4 percentage of participants

SECONDARY outcome

Timeframe: Week 12 (Last visit/early termination visit)

Population: ITT population consisted of the entire population enrolled and randomized. Here the overall number of participants analyzed signifies participants who were evaluable for this outcome measure.

Part D of subject satisfaction questionnaire consisted of following 4 questions about the cosmetic product moisturizer: 1-Skin feel soft and smooth, 2-Improve my skin moisture, 3-Leave my skin hydrated and protected, 4-Provide comforting sensation.

Outcome measures

Outcome measures
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=123 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks.	Ivermectin 1% Cream + Oral Placebo Capsules n=129 Participants Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks. Oral placebo capsules: 1 Capsule once-daily for 12 weeks.
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D 1.Skin feel soft and smooth	48.0 percentage of participants	35.7 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D 2.Improve my skin moisture	38.2 percentage of participants	34.1 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D 3.Leave my skin hydrated and protected	42.3 percentage of participants	38.0 percentage of participants
Percentage of Participants Who Reported Strongly Agree for Subject Satisfaction Questionnaire at Week 12 (Last Visit/Early Termination Visit): Part D 4.Provide comforting sensation	43.9 percentage of participants	37.2 percentage of participants

Adverse Events

Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Ivermectin 1% Cream + Oral Placebo Capsules

Serious events: 1 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 participants at risk Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks	Ivermectin 1% Cream + Oral Placebo Capsules n=138 participants at risk Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Musculoskeletal and connective tissue disorders Multilevel discopathy in the cervical spine	0.74% 1/135 • Number of events 1 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	0.00% 0/138 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Hepatobiliary disorders Cholezystolithiasis	0.00% 0/135 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	0.72% 1/138 • Number of events 1 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.

Other adverse events

Other adverse events
Measure	Ivermectin 1% Cream + Doxycycline 40 mg MR Capsules n=135 participants at risk Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Doxycycline 40 mg MR (30 mg Immediate Release \& 10 mg Delayed Release beads) capsules: 1 Capsule once-daily for 12 weeks	Ivermectin 1% Cream + Oral Placebo Capsules n=138 participants at risk Ivermectin 1% cream: Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks Oral placebo capsules: 1 Capsule once-daily for 12 weeks
Gastrointestinal disorders Diarrhoea	0.74% 1/135 • Number of events 1 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	4.3% 6/138 • Number of events 6 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Gastrointestinal disorders Nausea	0.00% 0/135 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	1.4% 2/138 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Infections and infestations Gastroenteritis	0.00% 0/135 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	2.2% 3/138 • Number of events 3 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Infections and infestations Nasopharyngitis	4.4% 6/135 • Number of events 6 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	7.2% 10/138 • Number of events 10 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Infections and infestations Rhinitis	0.00% 0/135 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	1.4% 2/138 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Infections and infestations Upper respiratory tract infection	1.5% 2/135 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	1.4% 2/138 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Musculoskeletal and connective tissue disorders Spinal pain	1.5% 2/135 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	0.00% 0/138 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Nervous system disorders Headache	2.2% 3/135 • Number of events 3 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	2.2% 3/138 • Number of events 4 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.5% 2/135 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	0.72% 1/138 • Number of events 1 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Skin and subcutaneous tissue disorders Rosacea	0.74% 1/135 • Number of events 1 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	1.4% 2/138 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/135 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.	1.4% 2/138 • Number of events 2 • From the signing of the informed consent form (ICF) up to week 12 Safety population (all participants treated \[APT\]) - consisted of the ITT population, after exclusion of participants who never used the treatment with certainty based on monitoring report.

Additional Information

Rajeev Chavda

Galderma

Phone: 0033492382928

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place