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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adapalene/BPO Gel/Foam Wash/Moisturizer | Experimental | Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapalene/BPO Gel | Drug | Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2, 4, and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2, 4, and 8 weeks |
| Non-inflammatory Lesions |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2, 4, and 8 weeks |
| Scaling |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Joshua M Berlin, MD | Dermatology Associates, PA, of the Palm Beaches | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Protocol, Inc. | Boynton Beach | Florida | 33437 | United States | ||
| Tennessee Clinical Research Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population (all subjects who had at least 1 post-treatment administration evaluation) | Posted | Mean | Standard Deviation | lesions | Baseline, 2, 4, and 8 weeks |
|
8 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth M Nieman | Galderma Labratories, L.P. | 817-961-5130 | elizabeth.nieman@galderma.com |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| ID | Term |
|---|---|
| D000068801 | Adapalene, Benzoyl Peroxide Drug Combination |
| D000068816 | Adapalene |
| D001585 | Benzoyl Peroxide |
| D005782 | Gels |
| ID | Term |
|---|---|
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Moisturizer SPF 30 | Other | Moisturizer SPF 30 (once daily) |
|
|
| Foam Wash | Other | Foam Wash (twice daily) |
|
|
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
| Baseline, 2, 4, and 8 weeks |
| Subject Questionnaire | Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. | 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.
| Baseline, 2, 4, and 8 weeks |
| 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. | Baseline, 2, 4, and 8 weeks |
| 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. | Baseline, 2, 4, and 8 weeks |
| Nashville |
| Tennessee |
| 37215 |
| United States |
| Stephens & Associates | Carrollton | Texas | 75006 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| The Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| years |
|
| Sex: Female, Male | Safety Population | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Skin Type | Number | participants |
|
| Fitzpatrick Skin Type | Investigator assessment based on the standard Fitzpatrick Skin Type Scale (I to VI). TYPE 1: Highly sensitive, always burns, never tans. TYP E 2: Very sun sensitive, burns easily, tans minimally. TYPE 3: Sun sensitive skin, sometimes burns, slowly tans to light brown. TYPE 4: Minimally sun sensitive, burns minimally, always tans to moderate brown. TYPE 5: Sun insensitive skin, rarely burns, tans well. TYPE 6: Sun insensitive, never burns, deeply pigmented. -------------------------------------------------------------------------------- | Number | participants |
|
| History of Acne | Mean | Standard Deviation | years |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 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. | ITT population (all subjects who had at least 1 post-treatment administration evaluation) | Posted | Mean | Standard Deviation | lesions | Baseline, 2, 4, and 8 weeks |
|
|
|
| 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 | ITT population (all subjects who had at least 1 post-treatment administration evaluation) | Posted | Mean | Standard Deviation | lesions | Baseline, 2, 4, and 8 weeks |
|
|
|
| Secondary | Subject Questionnaire | Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks. | ITT population (all subjects who had at least 1 post-treatment administration evaluation) | Posted | Number | participants | Baseline, 2, 4, and 8 weeks |
|
|
|
| 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. | As observed population | Posted | Number | participants | Baseline, 2, 4, and 8 weeks |
|
|
|
| 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. | As observed population | Posted | Number | participants | Baseline, 2, 4, and 8 weeks |
|
|
|
| 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. | As observed population | Posted | Number | participants | Baseline, 2, 4, and 8 weeks |
|
|
|
| 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. | As observed population | Posted | Number | participants | Baseline, 2, 4, and 8 weeks |
|
|
|
| 0 |
| 81 |
| 13 |
| 81 |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Skin burning sensatation | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
| Accidental exposure to product by child | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
|
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| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D003102 | Colloids |
| D045424 | Complex Mixtures |
| D004304 | Dosage Forms |
| Title | Measurements |
|---|---|
|
| Week 8 |
|
| Title | Measurements |
|---|---|
|
| Week 8 |
|
| Title | Measurements |
|---|---|
|
| Dissatisfied |
|
| Very dissatisfied |
|
| Missing |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|
| Mild |
|
| Moderate |
|
| Severe |
|