Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

NCT00422240 | Completed Phase 3 Results

• 1 other identifier: RD.06.SPR.18087
• Study Type: interventional
• Target: 1,668
• Locations: 1 country
• Sites: 1

Brief Summary

This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study. The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Conditions

Acne Vulgaris

Keywords

Acne vulgaris; Adapalene; Benzoyl Peroxide

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants Who Achieved Success Rate 0 (Clear) or 1 (Almost Clear) on the Investigator Global Assessment (IGA) Scale at Week 12 (Last Observation Carried Forward)

  Success rate was defined as percentage of participants who achieved "Clear" or "Almost Clear" score on the IGA scale. IGA scale consisted of 5 grades (0-4) among which 0 = Clear (Minor, residual discoloration, no erythema or induration/papulation, no oozing/crusting), 1 = Almost clear (Trace, faint pink erythema with almost no induration/papulation and no oozing/crusting), 2 = Mild (Faint pink erythema with mild induration/papulation and no oozing/crusting), 3 = Moderate (Pink-red erythema with moderate induration/papulation and there may be some oozing/crusting.), 4 = Severe (Deep/bright red erythema with severe induration/papulation with oozing/crusting). All missing values were imputed by LOCF.

  At Week 12

• Change in Inflammatory Lesion Count From Baseline to Week 12

  Change in inflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.

  Baseline to Week 12

• Change in Noninflammatory Lesion Count From Baseline to Week 12

  Change in noninflammatory lesion count from baseline to week 12 was reported. All missing values were imputed by LOCF.

  Baseline to Week 12

Secondary Outcomes (3)

• Percent Change From Baseline in Inflammatory Lesion Counts at Week 12

  Baseline, Week 12

• Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12

  Baseline, Week 12

• Percent Change From Baseline in Total Lesion Counts at Week 12

  Baseline, Week 12

Study Arms (4)

Adapalene/Benzoyl Peroxide Gel

EXPERIMENTAL

Participants were treated with adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.

Drug: Adapalene/Benzoyl Peroxide

Adapalene Gel, 0.1%

EXPERIMENTAL

Participants were treated with 0.1% of adapalene gel topically daily in the evening for 12 Weeks.

Drug: Adapalene Gel, 0.1%

Benzoyl Peroxide Gel 2.5%

EXPERIMENTAL

Participants were treated with 2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.

Drug: Benzoyl Peroxide Gel 2.5%

Gel Vehicle

PLACEBO COMPARATOR

Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Drug: Gel Vehicle

Interventions

Adapalene/Benzoyl Peroxide DRUG

Adapalene 0.1 % \[weight by weight (W/W)\]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.

Adapalene/Benzoyl Peroxide Gel

Adapalene Gel, 0.1% DRUG

0.1% of adapalene gel topically daily in the evening for 12 Weeks.

Adapalene Gel, 0.1%

Benzoyl Peroxide Gel 2.5% DRUG

2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.

Benzoyl Peroxide Gel 2.5%

Gel Vehicle DRUG

Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Gel Vehicle

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A clinical diagnosis of acne vulgaris with facial involvement.
• A minimum of 20 but not more than 50 inflammatory lesions
• A minimum of 30 but not more than 100 noninflammatory lesions
• A score of 3 (Moderate) on the Investigator's Global Assessment Scale

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Miller MD

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• Leyden JJ. A review of the use of combination therapies for the treatment of acne vulgaris. J Am Acad Dermatol. 2003 Sep;49(3 Suppl):S200-10. doi: 10.1067/s0190-9622(03)01154-x.

  PMID: 12963896 BACKGROUND

• Gold LS, Tan J, Cruz-Santana A, Papp K, Poulin Y, Schlessinger J, Gidner J, Liu Y, Graeber M; Adapalene-BPO Study Group. A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne. Cutis. 2009 Aug;84(2):110-6.

  PMID: 19746769 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene, Benzoyl Peroxide Drug Combination; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Benzoyl Peroxide; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Adapalene; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Colloids; Complex Mixtures; Dosage Forms

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Michael Graeber, MD

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 15, 2007
• Study Start: June 27, 2006
• Primary Completion: July 12, 2007
• Study Completion: July 12, 2007
• Last Updated: April 15, 2024
• Results First Posted: April 15, 2024

Record last verified: 2023-10

Locations

US (1)