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

NCT02735421 | Completed Phase 4 Results

• 2 other identifiers: RD.03.SPR.1050612016-002666-31
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 7

Brief Summary

This was a multi-centre, randomized, investigator blinded, vehicle controlled trial using intra-individual comparison (right half-face versus left half-face). Participants with each half-face randomized to one of the two following treatments:

• Adapalene 0.3 percent (%) - benzoyl peroxide (BPO) 2.5% gel (TactuPump® Forte).
• Vehicle gel The main objective of this trial was to evaluate the effect of Adapalene 0.3% - BPO 2.5% (ABPO Forte) gel versus vehicle gel on the risk of formation of atrophic acne scars in moderate to severe acne participants.

Conditions

Acne Vulgaris; Atrophic Acne Scars

Keywords

acne; scars

Outcome Measures

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.

  Week 24

Secondary Outcomes (8)

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

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

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

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

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

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

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

  At Week 12 and Week 24

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

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

Study Arms (4)

Part 1: ABPO Forte Gel

EXPERIMENTAL

Drug: ABPO Forte Gel

Part 1: ABPO Forte Vehicle Gel

PLACEBO COMPARATOR

Drug: Vehicle gel

Part 2: ABPO Forte Gel

EXPERIMENTAL

Drug: ABPO Forte Gel

Part 2: ABPO Forte Vehicle Gel

PLACEBO COMPARATOR

Drug: Vehicle gel

Interventions

ABPO Forte Gel DRUG

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

Part 1: ABPO Forte Gel; Part 2: ABPO Forte Gel

Vehicle gel DRUG

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.

Part 1: ABPO Forte Vehicle Gel; Part 2: ABPO Forte Vehicle Gel

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:
• Investigator's Global Assessment score of 3 or 4, with same score on both sides; and
• A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and
• No more than two acne nodules (less than or equal to \[\>=\] 1 centimeter \[cm\]); and
• A minimum of 10 atrophic acne scars in total (upper than 2 millimeters \[mm\]) (excluding the nose)
• Participants with a symmetric number of both inflammatory and non-inflammatory lesions on the whole face, and atrophic acne scars on the whole face.
• Participants with skin phototype of I to IV on Fitzpatrick's scale.

You may not qualify if:

• Participants with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment.
• Prior failure to treatment with TactuPump® Forte (Adapalene 0.3% - BPO 2.5%).
• Participants with more than 3 excoriated acne lesions.
• Participants with skin abraded on the treated area or affected by eczema, seborrhoeic dermatitis, cuts or sunburn.
• Female participant who is pregnant, nursing or planning a pregnancy during the trial or within one month after the last trial treatment application.
• Male participant with a beard or facial hair, which would interfere with the clinical trial evaluations or clinical trial procedures.
• Participants having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, hydroxyacids, Zinc containing treatments, antibacterials, antiseptics, other anti-inflammatory drugs or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Photodynamic therapy, laser therapy, microdermabrasion for acne (3 months).
• Participants having received at least one of the following systemic treatments: Corticosteroids (except locally acting corticosteroids such as inhaled or intrathecal or dermal application at distance from the face), antibiotics (except penicillin) (1 month); Spironolactone (3 months) / Drospirenone (3 months, unless dose is stable since at least 3 months); Oral retinoids (6 months); Cyproterone acetate / Chlormadinone acetate (6 months); Immunomodulators (3 months).

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (7)

Unknown Facility

Markham, Ontario, Canada

Location

Unknown Facility

Oakville, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

Unknown Facility

Windsor, Ontario, Canada

Location

Unknown Facility

Montreal, Quebec, Canada

Location

Unknown Facility

Saint-Jérôme, Quebec, Canada

Location

Unknown Facility

Nantes, France

Location

Related Publications (2)

• 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.

  PMID: 31209851 BACKGROUND

• 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.

  PMID: 29549588 BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris; Cicatrix

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 12, 2016
• Study Start: May 13, 2016
• Primary Completion: June 5, 2017
• Study Completion: November 23, 2017
• Last Updated: September 14, 2022
• Results First Posted: November 15, 2019

Record last verified: 2022-08

Locations

FR (1); CA (6)