Trial Outcomes & Findings for Efficacy and Safety of CD5024 1% in Acne Vulgaris (NCT NCT03034460)

NCT ID: NCT03034460

Last Updated: 2020-12-11

Results Overview

Inflammatory lesion count corresponded to the sum of papules and pustules.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: Day 40
• Results posted on: 2020-12-11

Participant Flow

This study was conducted at six centers in three countries (Germany, France, Canada) between 25 April 2016 (first participant screened) to 02 November 2016 (last participant completed).

A total of 70 participants were randomized, of which 64 participants completed the study.

Participant milestones

Measure	Group I: CD5024 Cream Versus Its Vehicle Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.	Group II: Epiduo Gel Versus Its Vehicle Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
Overall Study STARTED	48	22
Overall Study COMPLETED	45	19
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	Group I: CD5024 Cream Versus Its Vehicle Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.	Group II: Epiduo Gel Versus Its Vehicle Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
Overall Study Adverse Event	0	1
Overall Study Withdrawal by Subject	2	2
Overall Study Personal Reasons	1	0

Baseline Characteristics

Efficacy and Safety of CD5024 1% in Acne Vulgaris

Baseline characteristics by cohort

Measure	Group I: CD5024 Cream Versus Its Vehicle n=48 Participants Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.	Group II: Epiduo Gel Versus Its Vehicle n=22 Participants Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.	Total n=70 Participants Total of all reporting groups
Age, Continuous	23.3 Years STANDARD_DEVIATION 4.7 • n=93 Participants	23.4 Years STANDARD_DEVIATION 4.4 • n=4 Participants	23.3 Years STANDARD_DEVIATION 4.6 • n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	14 Participants n=4 Participants	48 Participants n=27 Participants
Sex: Female, Male Male	14 Participants n=93 Participants	8 Participants n=4 Participants	22 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) White	46 Participants n=93 Participants	14 Participants n=4 Participants	60 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Number of inflammatory lesions	34.0 Lesion Count STANDARD_DEVIATION 11.6 • n=93 Participants	34.2 Lesion Count STANDARD_DEVIATION 15.1 • n=4 Participants	34.0 Lesion Count STANDARD_DEVIATION 12.7 • n=27 Participants

PRIMARY outcome

Timeframe: Day 40

Population: This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT-population included all participants who were randomized. Outcome measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Inflammatory lesion count corresponded to the sum of papules and pustules.

Outcome measures

Measure	CD5024 1% Cream n=48 One side of face Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 One side of face Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Inflammatory Lesion Count (Papules and Pustules) at Day 40	10.1 lesion count Standard Deviation 5.8	8.9 lesion count Standard Deviation 5.0	6.1 lesion count Standard Deviation 4.9	9.4 lesion count Standard Deviation 5.7

SECONDARY outcome

Timeframe: Baseline (Day 1)

Population: This analysis was performed on ITT population. ITT population included all partcipants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Inflammatory lesion count corresponded to the sum of papules and pustules.

Outcome measures

Measure	CD5024 1% Cream n=48 One side of face Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 One side of face Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)	16.5 lesion count Standard Deviation 4.9	17.5 lesion count Standard Deviation 7.4	17.6 lesion count Standard Deviation 8.6	16.6 lesion count Standard Deviation 7.2

SECONDARY outcome

Timeframe: Baseline (Day 1), and Day 40

Population: This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Inflammatory lesion count corresponded to the sum of papules and pustules.

Outcome measures

Measure	CD5024 1% Cream n=48 One side of face Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 One side of face Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40	35.7 percent reduction of lesion count Standard Deviation 43.4	44.4 percent reduction of lesion count Standard Deviation 32.3	65.5 percent reduction of lesion count Standard Deviation 24.0	42.5 percent reduction of lesion count Standard Deviation 30.1

SECONDARY outcome

Timeframe: Baseline (Day 1), and Day 40

Population: This analysis was performed on ITT- last observation carried forward (LOCF) population. ITT population included all participants who were randomized. Outcome Measure data was summarized using the LOCF at Day 40. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.

Outcome measures

Measure	CD5024 1% Cream n=48 One side of face Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 One side of face Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Total Lesion Count at Baseline (Day 1) and Day 40 Baseline (Day 1)	37.7 lesion count Standard Deviation 11.2	39.4 lesion count Standard Deviation 13.7	37.3 lesion count Standard Deviation 20.2	36.4 lesion count Standard Deviation 18.0
Total Lesion Count at Baseline (Day 1) and Day 40 Day 40	26.4 lesion count Standard Deviation 16.8	25.9 lesion count Standard Deviation 14.3	19.3 lesion count Standard Deviation 15.0	25.5 lesion count Standard Deviation 17.2

SECONDARY outcome

Timeframe: Baseline (Day 1), and Day 40

Population: This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.

Outcome measures

Measure	CD5024 1% Cream n=48 One side of face Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 One side of face Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40	32.5 percent reduction in total lesion count Standard Deviation 32.2	34.0 percent reduction in total lesion count Standard Deviation 27.1	50.2 percent reduction in total lesion count Standard Deviation 27.2	27.8 percent reduction in total lesion count Standard Deviation 31.8

SECONDARY outcome

Timeframe: Baseline (Day 1), and Day 40

Population: This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.

Outcome measures

Measure	CD5024 1% Cream n=48 One side of face Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 One side of face Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 Baseline (Day 1)	21.1 lesion count Standard Error 9.5	21.8 lesion count Standard Error 10.7	19.6 lesion count Standard Error 14.1	19.6 lesion count Standard Error 13.6
Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 Day 40	16.2 lesion count Standard Error 13.1	16.9 lesion count Standard Error 12.7	13.0 lesion count Standard Error 12.0	16.0 lesion count Standard Error 14.1

SECONDARY outcome

Timeframe: Baseline (Day 1), and Day 40

Population: This analysis was performed on ITT population. ITT population included all participants who were randomized. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.

Outcome measures

Measure	CD5024 1% Cream n=48 One side of face Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 One side of face Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 One side of face Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40	27.8 percent reduction of lesion count Standard Deviation 39.4	21.3 percent reduction of lesion count Standard Deviation 42.0	36.9 percent reduction of lesion count Standard Deviation 36.1	11.7 percent reduction of lesion count Standard Deviation 48.6

SECONDARY outcome

Timeframe: Day 40

Population: This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.

The Investigator gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.

Outcome measures

Measure	CD5024 1% Cream n=48 Participants Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 Participants Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 Day 40 (Active much better than Vehicle)	0 Participants	4 Participants	—	—
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 Day 40 (Active better than Vehicle)	16 Participants	7 Participants	—	—
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 Day 40 (No clinical difference between Active and Vehicle)	16 Participants	6 Participants	—	—
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 Day 40 (Vehicle better than Active)	14 Participants	4 Participants	—	—
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 Day 40 (Vehicle much better than Active)	1 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Day 40

Population: This analysis was performed on ITT population. ITT population included all participants who were randomized. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this endpoint.

The participants gave opinion on their preference after comparison of the left and right sides of the face using the 5-point scale ranging from -2 to 2. The score and description indicated as follows: -2= left side of the face much better than right side, -1= left side of the face better than right side, 0= no clinical difference between the right and left sides of the face, 1= right side of the face better than the left side, 2= right side of the face much better than the left side.

Outcome measures

Measure	CD5024 1% Cream n=47 Participants Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=21 Participants Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 Day 40 (Active much better than Vehicle)	2 Participants	2 Participants	—	—
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 Day 40 (Active better than Vehicle)	11 Participants	11 Participants	—	—
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 Day 40 (No clinical difference between Active and Vehicle)	15 Participants	4 Participants	—	—
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 Day 40 (Vehicle better than Active)	16 Participants	3 Participants	—	—
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 Day 40 (Vehicle much better than Active)	3 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: From start of study up to follow up (Week 7)

Population: This analysis was performed on safety population. Safety population included participants in the ITT population who received at least 1 application of the investigational product. Number of participants with AE's were reported.

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.

Outcome measures

Measure	CD5024 1% Cream n=48 Participants Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=22 Participants Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Number of Participants With Adverse Events (AEs)	32 Participants	14 Participants	—	—

SECONDARY outcome

Timeframe: From Day 1 up Follow up (Week 7)

Population: Safety population included participants in the ITT population who received at least 1 application of the investigational product. Here 'n' (number analyzed) signifies number of participants who were evaluable for each specified category. The data was planned, analyzed and reported for active (cream/gel) application on one side of face and vehicle controlled (matched cream/gel) on other side of face.

Signs and symptoms of local cutaneous irritation(local tolerability [erythema, scaling, dryness, stinging/burning, pruritus]) were evaluated on all treated areas (face and behind ears if applicable) every day from Day 1 up to follow-up (Week 7) using a 4-point scale of None (0), Mild (1), Moderate (2), or Severe (3). Number of participants reported worst local tolerability score on treated areas from Day 1 to follow up (Week 7) was reported.

Outcome measures

Measure	CD5024 1% Cream n=48 Participants Participants applied CD5024 1% cream once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	CD5024 1% Cream Matched Placebo n=48 Participants Participants applied CD5024 1% cream matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde n=22 Participants Participants applied Adapalene Benzoyl Peroxyde once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.	Adapalene Benzoyl Peroxyde Matched Placebo n=22 Participants Participants applied Adapalene Benzoyl Peroxyde matched placebo once daily for 5 days a week from Week 1 to Week 5 and for 4 days during Week 6.
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Erythema: 0-None	37 Participants	38 Participants	8 Participants	15 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Erythema: 1-Mild	9 Participants	9 Participants	11 Participants	6 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Erythema: 2-Moderate	2 Participants	1 Participants	3 Participants	1 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Scaling/Desquamation: 0-None	38 Participants	38 Participants	5 Participants	16 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Scaling/Desquamation: 1-Mild	10 Participants	10 Participants	13 Participants	5 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Scaling/Desquamation: 2- Moderate	0 Participants	0 Participants	4 Participants	1 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Dryness: 0-None	38 Participants	37 Participants	4 Participants	10 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Dryness: 1-Mild	10 Participants	11 Participants	13 Participants	12 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Dryness: 2-Moderate	0 Participants	0 Participants	5 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Stinging/Burning: 0-None	44 Participants	43 Participants	8 Participants	17 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Stinging/Burning: 1-Mild	3 Participants	4 Participants	8 Participants	5 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Face: Stinging/Burning: 2-Moderate	1 Participants	1 Participants	6 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Erythema: 0-None	20 Participants	20 Participants	8 Participants	11 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Erythema: 1-Mild	2 Participants	2 Participants	2 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Erythema: 2-Moderate	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Scaling/Desquamation: 0-None	22 Participants	22 Participants	7 Participants	11 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Scaling/Desquamation: 1-Mild	0 Participants	0 Participants	3 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Scaling/Desquamation: 2-Moderate	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Dryness: 0-None	22 Participants	22 Participants	7 Participants	10 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Dryness: 1-Mild	0 Participants	0 Participants	3 Participants	1 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Dryness: 2-Moderate	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Stinging/Burning: 0-None	22 Participants	22 Participants	8 Participants	11 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Stinging/Burning: 1-Mild	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) Ear: Stinging/Burning: 2-Moderate	0 Participants	0 Participants	1 Participants	0 Participants

Adverse Events

Group I: CD5024 Cream Versus Its Vehicle

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Group II: Epiduo Gel Versus Its Vehicle

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Group I: CD5024 Cream Versus Its Vehicle n=48 participants at risk Participants applied 500 microliter (mcL) of CD5024 1% cream on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.	Group II: Epiduo Gel Versus Its Vehicle n=22 participants at risk Participants applied 500 mcL of Adapalene benzoyl peroxyde (Epiduo) gel on one side of the face and matching placebo cream on the other side of the face once daily for 5 days a week from Week 1 to Week 5 and 4 days during Week 6 for a total of 29 applications.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	6.2% 3/48 • Number of events 3 • From start of study up to follow up (Week 7)	0.00% 0/22 • From start of study up to follow up (Week 7)
Nervous system disorders Headache	27.1% 13/48 • Number of events 13 • From start of study up to follow up (Week 7)	22.7% 5/22 • Number of events 5 • From start of study up to follow up (Week 7)
Gastrointestinal disorders Abdominal pain	6.2% 3/48 • Number of events 3 • From start of study up to follow up (Week 7)	0.00% 0/22 • From start of study up to follow up (Week 7)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/48 • From start of study up to follow up (Week 7)	9.1% 2/22 • Number of events 2 • From start of study up to follow up (Week 7)
Infections and infestations Nasopharyngitis	29.2% 14/48 • Number of events 14 • From start of study up to follow up (Week 7)	18.2% 4/22 • Number of events 4 • From start of study up to follow up (Week 7)

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: Clinical.Studies@galderma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place