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

NCT ID: NCT02735421

Last Updated: 2022-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-13
• Study Completion Date: 2017-11-23

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Part 1: ABPO Forte Gel

Group Type: EXPERIMENTAL

ABPO Forte Gel

Intervention Type: 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.

Part 1: ABPO Forte Vehicle Gel

Group Type: PLACEBO_COMPARATOR

Vehicle gel

Intervention Type: 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 2: ABPO Forte Gel

Group Type: EXPERIMENTAL

ABPO Forte Gel

Intervention Type: 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.

Part 2: ABPO Forte Vehicle Gel

Group Type: PLACEBO_COMPARATOR

Vehicle gel

Intervention Type: 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.

Interventions

ABPO 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.

Intervention Type: DRUG

Vehicle 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.

Intervention Type: DRUG

Other Intervention Names

TactuPump Forte

Eligibility Criteria

Inclusion Criteria

• Participants with clinical diagnosis of moderate to severe acne vulgaris on the face defined by:

1. Investigator's Global Assessment score of 3 or 4, with same score on both sides; and

2. A minimum of 25 inflammatory lesions (papules and pustules) in total, with at least 10 on each side (excluding the nose); and

3. No more than two acne nodules (less than or equal to [>=] 1 centimeter [cm]); and

4. 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Markham, Ontario, Canada

Oakville, Ontario, Canada

Toronto, Ontario, Canada

Windsor, Ontario, Canada

Montreal, Quebec, Canada

Saint-Jérôme, Quebec, Canada

Nantes, , France

Countries

Canada; France

References

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.

Reference Type: BACKGROUND

PMID: 31209851 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29549588 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002666-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RD.03.SPR.105061

Identifier Type: -

Identifier Source: org_study_id