Adapalene 0.3% - Benzoyl Peroxide 2.5% Gel and Risk of Formation of Atrophic Acne Scars

Browse trials for

• Acne Vulgaris 750
• Cicatrix 317

Keywords

• acne
• scars

Acne Vulgaris

750 studies on the registry are indexed under Acne Vulgaris; 89 are open to participants now.

This study's enrollment of 67 is close to the median of 69 across 647 interventional studies indexed under Acne Vulgaris.

Lead sponsor

Galderma R&D is the lead sponsor of 283 studies on the registry; 10 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 55 (92%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Part 1: ABPO Forte Gel

  Drug: ABPO Forte Gel

• Placebo comparator
  Part 1: ABPO Forte Vehicle Gel

  Drug: Vehicle gel

• Experimental
  Part 2: ABPO Forte Gel

  Drug: ABPO Forte Gel

• Placebo comparator
  Part 2: ABPO Forte Vehicle Gel

  Drug: Vehicle gel

Interventions

• DrugABPO Forte Gel

  Participants applied Adapalene 0.3% - Benzoyl peroxide (BPO) 2.5% gel (ABPO Forte) topically to the affected areas once daily for 24 weeks in Part 1 and for 48 weeks in Part 2.

  Also known as: TactuPump Forte

• DrugVehicle gel

  Participants applied placebo matched to ABPO Forte gel topically to the affected areas once daily for 24 weeks in Part 1 and 48 weeks in Part 2.

Primary outcomes

1. Part 1: Total Atrophic Acne Scar Count Per Half-face

   The scars were counted according to their size defined in two categories using 2-millimeter (mm) and 4-mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars greater than (\>) 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.

   Time frame: Week 24

Secondary outcomes

1. Part 1 and Part 2: Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit

   The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin. To obtain the total number of atrophic scars per half-face, atrophic acne scar counts for each half-face was added.

   Time frame: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48

2. Part 1 and Part 2: Percent Change From Baseline in Total Atrophic Acne Scar Count Per Half-face at Each Post-baseline Visit

   The scars were counted according to their size defined in two categories using 2 mm and 4 mm punch biopsy tools for size classification: 1) atrophic scars 2 to 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types; 2) atrophic scars \> 4 mm: included boxcar (sheer edges), rolling (irregular surface), and undetermined types. Each type of atrophic acne scar was counted separately for each half-face by the evaluator for following regions: right forehead, right cheek, right side of the chin, left forehead, left cheek and left side of the chin.

   Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48

3. Part 1 and Part 2: Investigator's Scar Global Assessment (ISGA) Score

   ISGA was an assessment scale used to evaluate facial acne severity. ISGA was recorded using a 5-point scale ranges from 0 to 4, where (0 = clear \[No visible scars from acne); 1 = almost clear \[Hardly visible scars from 50 cm away\]; 2 = mild \[Easily recognizable; less than half the affected face area\]; 3 = moderate \[More than half and less than 75% of the affected face area\]; 4 = severe \[More than 75% of the affected face area\]) based on inflammation, pustules and papulation/infiltration. Higher score indicated severe acne.

   Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48

4. Part 1: Percentage of Participants With Investigator's Preference on Overall Scar Severity

   The investigator rated their preference on a scale ranging from -2 (left side a lot better than right) to 2 (right side a lot better than left). Overall scar severity was assessed using a 5-point scale where (-2 = Left a lot better than right; -1 = Left a little bit better than right; 0 = No preference; 1 = Right a little bit better than left; 2 = Right a lot better than left. ABPO forte was applied on left side and vehicle gel was applied on right side.

   Time frame: At Week 12 and Week 24

5. Part 1 and Part 2: Percent Change From Baseline in Total Lesion Count Per Half-face at Each Post-baseline Visit

   Total lesion counts corresponded to the sum of inflammatory and non-inflammatory lesions, and other lesions. The investigator counted all inflammatory lesions (papules and pustules), non-inflammatory lesions (open and closed comedone) and other lesions (nodules) for each half-face.

   Time frame: Part 1: Weeks 1, 4, 8, 12, 16 and 20; Part 2: Weeks 1, 4, 8, 12, 16, 20, 36 and 48

6. Part 1 and Part 2: Percent Change From Baseline in Inflammatory Lesion Count Per Half-face at Each Post-baseline Visit

   Inflammatory lesions included papules and pustules. Papule is a small, solid elevation less than one centimeter in diameter. Most of the lesion is above the surface of the skin. Pustule is a small, circumscribed elevation of the skin which contains yellow-white exudates.

   Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48

7. Part 1 and Part 2: Percent Change From Baseline in Non-inflammatory Lesion Count Per Half-face at Each Post-baseline Visit

   Non-inflammatory lesions included open comedone and closed comedone. Open comedone is a mass of sebaceous material that is impacted behind an open follicular orifice (blackhead). Closed comedone is a mass of sebaceous material that is impacted behind a closed follicular orifice (white head).

   Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48

8. Part 1 and Part 2: Investigator's Global Assessment (IGA) Score Per Half-face at Each Post-baseline Visit

   IGA is an assessment scale used to determine severity of acne and clinical response to treatment on a 5-point scale (0 = clear \[Clear skin with no inflammatory or non inflammatory lesions\]; 1= almost clear \[A few scattered comedones and a few small papules\]; 2= mild \[Easily recognizable; less than half the face is involved. Some comedones and some papules and pustules\]; 3= moderate \[More than half of the face is involved. Many comedones, papules and pustules. One small nodule may be present\] and 4= severe \[Entire face is involved. Covered with comedones, numerous papules and pustules. Few nodules may or may not be present\]) based on erythema and papulation/ infiltration. Therapeutic response is an IGA score of 0 (clear) or 1 (almost clear).

   Time frame: Part 1: Weeks 1, 4, 8, 12, 16, 20 and 24; Part 2: Weeks 1, 4, 8, 12, 16, 20, 24, 36 and 48

Baseline characteristics

Publications

• Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Chavda R, Kerrouche N, Tan J. Long-Term Effectiveness and Safety of Up to 48 Weeks' Treatment with Topical Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in the Prevention and Reduction of Atrophic Acne Scars in Moderate and Severe Facial Acne. Am J Clin Dermatol. 2019 Oct;20(5):725-732. doi: 10.1007/s40257-019-00454-6. PubMed 31209851 ↗
• Dreno B, Bissonnette R, Gagne-Henley A, Barankin B, Lynde C, Kerrouche N, Tan J. Prevention and Reduction of Atrophic Acne Scars with Adapalene 0.3%/Benzoyl Peroxide 2.5% Gel in Subjects with Moderate or Severe Facial Acne: Results of a 6-Month Randomized, Vehicle-Controlled Trial Using Intra-Individual Comparison. Am J Clin Dermatol. 2018 Apr;19(2):275-286. doi: 10.1007/s40257-018-0352-y. PubMed 29549588 ↗

Study documents

• Study protocol · Jul 6, 2016
• Statistical analysis plan · Jun 27, 2017

Documents are hosted by the registry — open the source record to download them.