Acne
Conditions
Brief summary
Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle.
Detailed description
Study drugs application will be performed once daily, 5 days a week during 6 weeks
Interventions
DRUGCD5024 1% cream
500 µL on half-face, five days a week during 6 weeks
DRUGCD5024 cream placebo
500 µL on half-face, five days a week during 6 weeks
DRUGCD0271/CD1579 gel
500 µL on half-face, five days a week during 6 weeks
DRUGCD0271/CD1579 gel placebo
500 µL on half-face, five days a week during 6 weeks
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. The subject is a male or a female aged from 18 to 35 years old at screening visit. 2. The subject has a medical diagnosis of acne vulgaris : 2.1 at least 20 (twenty) inflammatory lesions and a maximum of 100 (one hundred) non-inflammatory lesions (nose is excluded for the lesion count) at Baseline 2.2 symmetry of the lesions: No more than twice as many acne lesions on one side as compared to the other side at Baseline 3. If the subject is a female of childbearing potential, she must agree to use an effective contraceptive method for the duration of the study
Exclusion criteria
1. The subject has an underlying known disease surgical or medical condition, in the opinion of the investigator might interfere with interpretation of the study results or put the subject at risk (e.g., other dermatological diseases affecting the treatment area, such as a dermatitis, eczema, etc., or any uncontrolled chronic or serious diseases which would normally prevent participation in any clinical study, such as a cancer, leukemia or severe hepatic impairment), (Screening). 2. The subject has acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, or acne requiring systemic treatment. 3. The subject has a known or suspected allergies or sensitivities to any components of any of the study drugs (see Investigator's Brochure/Product label). 4. The subject is a male with beard or facial hair, which would interfere with clinical evaluation or clinical procedure (Screening and Baseline).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Lesion Count (Papules and Pustules) at Day 40 | Day 40 | Inflammatory lesion count corresponded to the sum of papules and pustules. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 | Baseline (Day 1), and Day 40 | Inflammatory lesion count corresponded to the sum of papules and pustules. |
| Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) | Baseline (Day 1) | Inflammatory lesion count corresponded to the sum of papules and pustules. |
| Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40 | Baseline (Day 1), and Day 40 | Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. |
| Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1), and Day 40 | Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. |
| Total Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1), and Day 40 | Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules. |
| Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 | Day 40 | 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. |
| Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 | 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. |
| Number of Participants With Adverse Events (AEs) | From start of study up to follow up (Week 7) | 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. |
| Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7) | From Day 1 up Follow up (Week 7) | 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. |
| Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 | Baseline (Day 1), and Day 40 | Non-inflammatory lesion counts corresponded to the sum of open and closed comedones. |
Countries
Canada, France, Germany
Participant flow
Recruitment details
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).
Pre-assignment details
A total of 70 participants were randomized, of which 64 participants completed the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 48 |
| 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. | 22 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Personal Reasons | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Group I: CD5024 Cream Versus Its Vehicle | Group II: Epiduo Gel Versus Its Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 23.3 Years STANDARD_DEVIATION 4.7 | 23.4 Years STANDARD_DEVIATION 4.4 | 23.3 Years STANDARD_DEVIATION 4.6 |
| Number of inflammatory lesions | 34.0 Lesion Count STANDARD_DEVIATION 11.6 | 34.2 Lesion Count STANDARD_DEVIATION 15.1 | 34.0 Lesion Count STANDARD_DEVIATION 12.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 46 Participants | 14 Participants | 60 Participants |
| Sex: Female, Male Female | 34 Participants | 14 Participants | 48 Participants |
| Sex: Female, Male Male | 14 Participants | 8 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 48 | 0 / 22 |
| other Total, other adverse events | 32 / 48 | 11 / 22 |
| serious Total, serious adverse events | 0 / 48 | 0 / 22 |
Outcome results
Primary
Inflammatory Lesion Count (Papules and Pustules) at Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 1% Cream | Inflammatory Lesion Count (Papules and Pustules) at Day 40 | 10.1 lesion count | Standard Deviation 5.8 |
| CD5024 1% Cream Matched Placebo | Inflammatory Lesion Count (Papules and Pustules) at Day 40 | 8.9 lesion count | Standard Deviation 5 |
| Adapalene Benzoyl Peroxyde | Inflammatory Lesion Count (Papules and Pustules) at Day 40 | 6.1 lesion count | Standard Deviation 4.9 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Inflammatory Lesion Count (Papules and Pustules) at Day 40 | 9.4 lesion count | Standard Deviation 5.7 |
Comparison: This analysis was performed in participants applied CD5024 1% Cream on one side of face and CD5024 1% Cream Matched Placebo on other side of face for paired difference between Active - Vehicle (CD5024 1% Cream \[n=48\] versus CD5024 1% Cream Matched Placebo \[n=48\]).p-value: =0.158Wilcoxon rank signed test
Comparison: This analysis was performed in participants applied Adapalene Benzoyl Peroxyde on one side of face and Adapalene Benzoyl Peroxyde Matched Placebo on the other side of face for paired difference between Active - Vehicle (Adapalene Benzoyl Peroxyde \[n=22\] versus Adapalene Benzoyl Peroxyde Matched Placebo \[n=22\]).p-value: =0.002Wilcoxon rank signed test
Secondary
Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1)
Inflammatory lesion count corresponded to the sum of papules and pustules.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 1% Cream | Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) | 16.5 lesion count | Standard Deviation 4.9 |
| CD5024 1% Cream Matched Placebo | Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) | 17.5 lesion count | Standard Deviation 7.4 |
| Adapalene Benzoyl Peroxyde | Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) | 17.6 lesion count | Standard Deviation 8.6 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Inflammatory Lesion Count (Papules and Pustules) at Baseline (Day 1) | 16.6 lesion count | Standard Deviation 7.2 |
Secondary
Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD5024 1% Cream | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 21.1 lesion count | Standard Error 9.5 |
| CD5024 1% Cream | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 16.2 lesion count | Standard Error 13.1 |
| CD5024 1% Cream Matched Placebo | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 16.9 lesion count | Standard Error 12.7 |
| CD5024 1% Cream Matched Placebo | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 21.8 lesion count | Standard Error 10.7 |
| Adapalene Benzoyl Peroxyde | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 13.0 lesion count | Standard Error 12 |
| Adapalene Benzoyl Peroxyde | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 19.6 lesion count | Standard Error 14.1 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 19.6 lesion count | Standard Error 13.6 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Non-Inflammatory Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 16.0 lesion count | Standard Error 14.1 |
Secondary
Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD5024 1% Cream | Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 | Day 40 (Active better than Vehicle) | 16 Participants |
| CD5024 1% Cream | Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 | Day 40 (Vehicle better than Active) | 14 Participants |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 | Day 40 (Vehicle much better than Active) | 0 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 | Day 40 (Active much better than Vehicle) | 4 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 | Day 40 (Active better than Vehicle) | 7 Participants |
| CD5024 1% Cream Matched Placebo | 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) | 6 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Investigator's Preference on a 5-Point Scale at Day 40 | Day 40 (Vehicle better than Active) | 4 Participants |
Secondary
Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD5024 1% Cream | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Active better than Vehicle) | 11 Participants |
| CD5024 1% Cream | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Vehicle better than Active) | 16 Participants |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Vehicle much better than Active) | 3 Participants |
| CD5024 1% Cream | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Active much better than Vehicle) | 2 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Vehicle much better than Active) | 1 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Active much better than Vehicle) | 2 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Active better than Vehicle) | 11 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (No clinical difference between Active and Vehicle) | 4 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants Reported for Participant's Preference on 5-Point Scale at Day 40 | Day 40 (Vehicle better than Active) | 3 Participants |
Secondary
Number of Participants Reported Worst Local Tolerability Score on Treated Areas (Face and Ear) From Day 1 to Follow up (Week 7)
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 | 1 Participants |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 | 43 Participants |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 | 11 Participants |
| CD5024 1% Cream Matched Placebo | 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 | 4 Participants |
| CD5024 1% Cream Matched Placebo | 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 | 37 Participants |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 | 38 Participants |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| CD5024 1% Cream Matched Placebo | 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 |
| Adapalene Benzoyl Peroxyde | 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 | 8 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 4 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 13 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 5 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 8 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 1 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 3 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 6 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 8 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 8 Participants |
| Adapalene Benzoyl Peroxyde | 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 |
| Adapalene Benzoyl Peroxyde | 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 | 1 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 1 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 7 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 3 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 1 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 2 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 8 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 11 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 7 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 3 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 5 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 13 Participants |
| Adapalene Benzoyl Peroxyde | 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 | 4 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 12 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 15 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 5 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 17 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 1 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 6 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 5 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 1 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 1 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 10 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 11 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 11 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 0 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 11 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 10 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 0 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 | 16 Participants |
| Adapalene Benzoyl Peroxyde Matched Placebo | 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 |
Secondary
Number of Participants With Adverse Events (AEs)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CD5024 1% Cream | Number of Participants With Adverse Events (AEs) | 32 Participants |
| CD5024 1% Cream Matched Placebo | Number of Participants With Adverse Events (AEs) | 14 Participants |
Secondary
Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40
Inflammatory lesion count corresponded to the sum of papules and pustules.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 1% Cream | Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 | 35.7 percent reduction of lesion count | Standard Deviation 43.4 |
| CD5024 1% Cream Matched Placebo | Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 | 44.4 percent reduction of lesion count | Standard Deviation 32.3 |
| Adapalene Benzoyl Peroxyde | Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 | 65.5 percent reduction of lesion count | Standard Deviation 24 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Percent Reduction From Baseline (Day 1) in Inflammatory Lesion Count at Day 40 | 42.5 percent reduction of lesion count | Standard Deviation 30.1 |
Secondary
Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 1% Cream | Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40 | 32.5 percent reduction in total lesion count | Standard Deviation 32.2 |
| CD5024 1% Cream Matched Placebo | Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40 | 34.0 percent reduction in total lesion count | Standard Deviation 27.1 |
| Adapalene Benzoyl Peroxyde | Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40 | 50.2 percent reduction in total lesion count | Standard Deviation 27.2 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Percent Reduction From Baseline (Day 1) in Total Lesions at Day 40 | 27.8 percent reduction in total lesion count | Standard Deviation 31.8 |
Secondary
Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40
Non-inflammatory lesion counts corresponded to the sum of open and closed comedones.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CD5024 1% Cream | Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 | 27.8 percent reduction of lesion count | Standard Deviation 39.4 |
| CD5024 1% Cream Matched Placebo | Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 | 21.3 percent reduction of lesion count | Standard Deviation 42 |
| Adapalene Benzoyl Peroxyde | Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 | 36.9 percent reduction of lesion count | Standard Deviation 36.1 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Percent Reduction From Baseline in Non-Inflammatory Lesion at Day 40 | 11.7 percent reduction of lesion count | Standard Deviation 48.6 |
Secondary
Total Lesion Count at Baseline (Day 1) and Day 40
Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and papules.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CD5024 1% Cream | Total Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 37.7 lesion count | Standard Deviation 11.2 |
| CD5024 1% Cream | Total Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 26.4 lesion count | Standard Deviation 16.8 |
| CD5024 1% Cream Matched Placebo | Total Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 25.9 lesion count | Standard Deviation 14.3 |
| CD5024 1% Cream Matched Placebo | Total Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 39.4 lesion count | Standard Deviation 13.7 |
| Adapalene Benzoyl Peroxyde | Total Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 37.3 lesion count | Standard Deviation 20.2 |
| Adapalene Benzoyl Peroxyde | Total Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 19.3 lesion count | Standard Deviation 15 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Total Lesion Count at Baseline (Day 1) and Day 40 | Baseline (Day 1) | 36.4 lesion count | Standard Deviation 18 |
| Adapalene Benzoyl Peroxyde Matched Placebo | Total Lesion Count at Baseline (Day 1) and Day 40 | Day 40 | 25.5 lesion count | Standard Deviation 17.2 |