Acne
Conditions
Brief summary
This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.
Interventions
DRUGAdapalene/BPO Gel
Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
OTHERMoisturizer SPF 30
Moisturizer SPF 30 (once daily)
OTHERFoam Wash
Foam Wash (twice daily)
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling.
Exclusion criteria
\- Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Lesion Count | Baseline, 2, 4, and 8 weeks | The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Lesions | Baseline, 2, 4, and 8 weeks | The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks. |
| Non-inflammatory Lesions | Baseline, 2, 4, and 8 weeks | The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks |
| Subject Questionnaire | Baseline, 2, 4, and 8 weeks | Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Erythema | Baseline, 2, 4, and 8 weeks | Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. |
| Scaling | Baseline, 2, 4, and 8 weeks | Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. |
| Dryness | Baseline, 2, 4, and 8 weeks | Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. |
| Stinging/Burning | Baseline, 2, 4, and 8 weeks | Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily) | 81 |
| Total | 81 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Protocol Violation | 2 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Adapalene/BPO Gel/Foam Wash/Moisturizer |
|---|---|
| Age, Continuous | 19.0 years STANDARD_DEVIATION 7.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 64 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type I | 3 participants |
| Fitzpatrick Skin Type II | 20 participants |
| Fitzpatrick Skin Type III | 16 participants |
| Fitzpatrick Skin Type IV | 19 participants |
| Fitzpatrick Skin Type V | 13 participants |
| Fitzpatrick Skin Type VI | 10 participants |
| History of Acne | 4.4 years STANDARD_DEVIATION 4.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) White | 48 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 41 Participants |
| Skin Type Combination | 22 participants |
| Skin Type Dry | 5 participants |
| Skin Type Normal | 22 participants |
| Skin Type Oily | 32 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
Total Lesion Count
The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Population: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Total Lesion Count | Baseline | 76.7 lesions | Standard Deviation 21.1 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Total Lesion Count | Week 2 | 53.9 lesions | Standard Deviation 25.5 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Total Lesion Count | Week 4 | 50.0 lesions | Standard Deviation 27.8 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Total Lesion Count | Week 8 | 43.7 lesions | Standard Deviation 22.7 |
Secondary
Inflammatory Lesions
The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Population: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Inflammatory Lesions | Week 2 | 17.4 lesions | Standard Deviation 9 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Inflammatory Lesions | Week 4 | 15.7 lesions | Standard Deviation 11.3 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Inflammatory Lesions | Week 8 | 14.4 lesions | Standard Deviation 9.5 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Inflammatory Lesions | Baseline | 27.3 lesions | Standard Deviation 6.4 |
Secondary
Non-inflammatory Lesions
The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks
Time frame: Baseline, 2, 4, and 8 weeks
Population: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Non-inflammatory Lesions | Baseline | 49.4 lesions | Standard Deviation 18.3 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Non-inflammatory Lesions | Week 2 | 36.4 lesions | Standard Deviation 21.5 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Non-inflammatory Lesions | Week 4 | 34.1 lesions | Standard Deviation 23.4 |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Non-inflammatory Lesions | Week 8 | 29.2 lesions | Standard Deviation 18.3 |
Secondary
Subject Questionnaire
Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Population: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Subject Questionnaire | Very satisfied | 23 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Subject Questionnaire | Satisfied | 42 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Subject Questionnaire | Undecided | 5 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Subject Questionnaire | Dissatisfied | 3 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Subject Questionnaire | Very dissatisfied | 1 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Subject Questionnaire | Missing | 3 participants |
Other Pre-specified
Dryness
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Population: As observed population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Dryness | None | 71 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Dryness | Mild | 10 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Dryness | Severe | 0 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Dryness | Moderate | 0 participants |
| Week 2 | Dryness | Mild | 22 participants |
| Week 2 | Dryness | Severe | 0 participants |
| Week 2 | Dryness | Moderate | 9 participants |
| Week 2 | Dryness | None | 45 participants |
| Week 4 | Dryness | Severe | 0 participants |
| Week 4 | Dryness | Mild | 19 participants |
| Week 4 | Dryness | Moderate | 1 participants |
| Week 4 | Dryness | None | 56 participants |
| Week 8 | Dryness | Moderate | 1 participants |
| Week 8 | Dryness | Mild | 11 participants |
| Week 8 | Dryness | None | 60 participants |
| Week 8 | Dryness | Severe | 0 participants |
Other Pre-specified
Erythema
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Population: As observed population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Erythema | None | 50 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Erythema | Mild | 28 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Erythema | Severe | 0 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Erythema | Moderate | 3 participants |
| Week 2 | Erythema | Mild | 20 participants |
| Week 2 | Erythema | Severe | 0 participants |
| Week 2 | Erythema | Moderate | 7 participants |
| Week 2 | Erythema | None | 49 participants |
| Week 4 | Erythema | None | 45 participants |
| Week 4 | Erythema | Severe | 0 participants |
| Week 4 | Erythema | Moderate | 5 participants |
| Week 4 | Erythema | Mild | 26 participants |
| Week 8 | Erythema | Severe | 0 participants |
| Week 8 | Erythema | None | 52 participants |
| Week 8 | Erythema | Mild | 18 participants |
| Week 8 | Erythema | Moderate | 2 participants |
Other Pre-specified
Scaling
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Population: As observed population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Scaling | Mild | 8 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Scaling | None | 73 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Scaling | Moderate | 0 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Scaling | Severe | 0 participants |
| Week 2 | Scaling | Severe | 0 participants |
| Week 2 | Scaling | Mild | 15 participants |
| Week 2 | Scaling | None | 57 participants |
| Week 2 | Scaling | Moderate | 4 participants |
| Week 4 | Scaling | None | 65 participants |
| Week 4 | Scaling | Moderate | 2 participants |
| Week 4 | Scaling | Severe | 0 participants |
| Week 4 | Scaling | Mild | 9 participants |
| Week 8 | Scaling | None | 63 participants |
| Week 8 | Scaling | Mild | 9 participants |
| Week 8 | Scaling | Moderate | 0 participants |
| Week 8 | Scaling | Severe | 0 participants |
Other Pre-specified
Stinging/Burning
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Time frame: Baseline, 2, 4, and 8 weeks
Population: As observed population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Stinging/Burning | Severe | 0 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Stinging/Burning | Mild | 1 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Stinging/Burning | Moderate | 0 participants |
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Stinging/Burning | None | 80 participants |
| Week 2 | Stinging/Burning | Severe | 0 participants |
| Week 2 | Stinging/Burning | Moderate | 5 participants |
| Week 2 | Stinging/Burning | Mild | 23 participants |
| Week 2 | Stinging/Burning | None | 48 participants |
| Week 4 | Stinging/Burning | Severe | 0 participants |
| Week 4 | Stinging/Burning | Mild | 12 participants |
| Week 4 | Stinging/Burning | Moderate | 1 participants |
| Week 4 | Stinging/Burning | None | 63 participants |
| Week 8 | Stinging/Burning | Severe | 0 participants |
| Week 8 | Stinging/Burning | Mild | 10 participants |
| Week 8 | Stinging/Burning | None | 62 participants |
| Week 8 | Stinging/Burning | Moderate | 0 participants |