Acne
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of use in adult men and women with mild to moderate facial acne, at least 5 inflammatory lesions, and at least 10 - 100 non-inflammatory lesions.
Detailed description
1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments 2. To characterize the effectiveness of the acne treatment in Investigator's Global Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments 3. To characterize the effect of the acne treatment in clinical grading of efficacy parameters through digital images at week 6, week 12, and week 24 as compared to baseline and compare between treatments 4. To characterize the effect of the acne treatment in subject self-assessment questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
Interventions
DRUGProduct A
Product A applied topically to the entire face or other affected area of the skin once daily
DRUGProduct B
Product B applied topically to affected area of the skin 1 to 3 times daily
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: 1. Men and women age 21 to 45 years at the time of enrollment. 2. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global Assessment Scale1) on the face. 3. Individuals with at least 5 inflammatory lesions. 4. Individuals with 10 - 100 non-inflammatory lesions. 5. Fitzpatrick skin type I-VI 6. Individuals willing to provide written informed consent including photo release, Health Insurance Portability and Accountability Act (HIPAA), and are able to read, speak,write, understand English. 7. Willing to withhold all facial treatments during the course of the study 8. Individuals of child bearing potential who use an acceptable method of contraception throughout the study. 9. Subjects must be stable on any medication they are taking for at least 30 days. Key
Exclusion criteria
1. Individuals diagnosed with allergies to topical acne products. 2. Individuals having a condition and/or disease of the skin that the Investigator deems inappropriate for participation. 3. Women who are nursing, pregnant, or planning to become pregnant during the study. 4. Individuals who have pre-existing or dormant dermatologic conditions on the face which in the opinion of the Investigator could interfere with the outcome of the study. 5. Individuals using or who have used any systemic medication considered to affect the course of acne, specifically, but not exclusively antibiotics or steroids within the last 30 days prior to entry into the study. 6. Individuals who are currently participating in another facial usage study or have participated in a clinical trial within 4 weeks prior to inclusion into the study. 7. Individuals with any planned surgeries and/or invasive medical procedures during the course of the study. 8. Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study. 9. Individuals with facial sunburn or excessive tanned facial skin or that are not willing to avoid daily sun exposure on the face and the use of tanning beds or sunless tanning products for the duration of the study. 10. Individuals that are currently taking or have taken within the last 30 days oral or topical prescription medications for acne.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Total Lesions at Week 12 | Baseline and 12 weeks | Percent change from baseline in total lesions at week 12 was assessed by investigator or designee. Investigator or designee counted and recorded the number of open comedones, closed comedones, papules, and pustules on each subject's face. Lesions were counted globally on the following facial locations/quadrants: forehead, left cheek, chin, and right cheek. Each of the following lesion types were analyzed separately for forehead, left cheek, chin, right cheek, and the total of the 4 areas: * Inflammatory acne lesions (sum of papules and pustules) * Non-inflammatory acne lesions (sum of open comedones and closed comedones) * Total lesion counts (sum of inflammatory and non-inflammatory acne lesions counts) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adapalene Subjects who were randomized to adapalene | 62 |
| Salicylic Acid Subjects who were randomized to salicylic acid. | 65 |
| Total | 127 |
Baseline characteristics
| Characteristic | Total | Adapalene | Salicylic Acid |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 117 Participants | 58 Participants | 59 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 24 Participants | 24 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 | 11 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 50 Participants | 26 Participants | 24 Participants |
| Region of Enrollment United States | 127 participants | 62 participants | 65 participants |
| Sex: Female, Male Female | 105 Participants | 49 Participants | 56 Participants |
| Sex: Female, Male Male | 12 Participants | 9 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 65 |
| other Total, other adverse events | 2 / 62 | 0 / 65 |
| serious Total, serious adverse events | 0 / 62 | 0 / 65 |
Outcome results
Primary
Percent Change From Baseline in Total Lesions at Week 12
Percent change from baseline in total lesions at week 12 was assessed by investigator or designee. Investigator or designee counted and recorded the number of open comedones, closed comedones, papules, and pustules on each subject's face. Lesions were counted globally on the following facial locations/quadrants: forehead, left cheek, chin, and right cheek. Each of the following lesion types were analyzed separately for forehead, left cheek, chin, right cheek, and the total of the 4 areas: * Inflammatory acne lesions (sum of papules and pustules) * Non-inflammatory acne lesions (sum of open comedones and closed comedones) * Total lesion counts (sum of inflammatory and non-inflammatory acne lesions counts)
Time frame: Baseline and 12 weeks
Population: A total of 127 were enrolled, but only 117 were included in the efficacy analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene | Percent Change From Baseline in Total Lesions at Week 12 | Pustules | -30.1 Percent change in lesions | Standard Deviation 153.2 |
| Adapalene | Percent Change From Baseline in Total Lesions at Week 12 | Inflammatory acne lesions | -10.0 Percent change in lesions | Standard Deviation 67 |
| Adapalene | Percent Change From Baseline in Total Lesions at Week 12 | Open comedones | -17.1 Percent change in lesions | Standard Deviation 117.4 |
| Adapalene | Percent Change From Baseline in Total Lesions at Week 12 | Non-inflammatory acne lesions | -34.7 Percent change in lesions | Standard Deviation 41.8 |
| Adapalene | Percent Change From Baseline in Total Lesions at Week 12 | Papules | -4.2 Percent change in lesions | Standard Deviation 71.7 |
| Adapalene | Percent Change From Baseline in Total Lesions at Week 12 | Total lesion counts | -28.3 Percent change in lesions | Standard Deviation 38.2 |
| Adapalene | Percent Change From Baseline in Total Lesions at Week 12 | Closed comedones | -13.0 Percent change in lesions | Standard Deviation 165.5 |
| Salicylic Acid | Percent Change From Baseline in Total Lesions at Week 12 | Total lesion counts | -17.5 Percent change in lesions | Standard Deviation 36.7 |
| Salicylic Acid | Percent Change From Baseline in Total Lesions at Week 12 | Open comedones | -45.6 Percent change in lesions | Standard Deviation 61.1 |
| Salicylic Acid | Percent Change From Baseline in Total Lesions at Week 12 | Closed comedones | 7.6 Percent change in lesions | Standard Deviation 153.8 |
| Salicylic Acid | Percent Change From Baseline in Total Lesions at Week 12 | Papules | 6.4 Percent change in lesions | Standard Deviation 83.5 |
| Salicylic Acid | Percent Change From Baseline in Total Lesions at Week 12 | Inflammatory acne lesions | 1.1 Percent change in lesions | Standard Deviation 72.6 |
| Salicylic Acid | Percent Change From Baseline in Total Lesions at Week 12 | Non-inflammatory acne lesions | -22.8 Percent change in lesions | Standard Deviation 43 |
| Salicylic Acid | Percent Change From Baseline in Total Lesions at Week 12 | Pustules | -18.2 Percent change in lesions | Standard Deviation 113.5 |