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

Acne Vulgaris Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422240
• Other study ID #: RD.06.SPR.18087
• Status: Completed
• Phase: Phase 3
• Start date: June 27, 2006
• Est. completion date: July 12, 2007

Study information

• Verified date: October 2023
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1668
• Est. completion date: July 12, 2007
• Est. primary completion date: July 12, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Adapalene/Benzoyl Peroxide
Adapalene 0.1 % [weight by weight (W/W)]/benzoyl peroxide 2.5 % (W/W) gel topically daily in the evening for 12 Weeks.
• Adapalene Gel, 0.1%
0.1% of adapalene gel topically daily in the evening for 12 Weeks.
• Benzoyl Peroxide Gel 2.5%
2.5% of benzoyl peroxide gel topically daily in the evening for 12 Weeks.
• Gel Vehicle
Participants were treated with gel vehicle topically daily in the evening for 12 Weeks.

Locations

Country	Name	City	State
United States	Miller MD	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Percent Change From Baseline in Inflammatory Lesion Counts at Week 12	The Inflammatory Lesion Count was the sum of papules and pustules. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.	Baseline, Week 12
Secondary	Percent Change From Baseline in Noninflammatory Lesion Counts at Week 12	The Noninflammatory Lesion Count was the sum of open comedones and closed comedones. Percent change from Baseline was calculated as the values at Week 12 minus the value at Baseline divided by Baseline value * 100. All missing values were imputed by LOCF.	Baseline, Week 12
Secondary	Percent Change From Baseline in Total Lesion Counts at Week 12	The Total Lesion Count was the sum of Inflammatory, Noninflammatory Lesion Counts, Nodules and Cysts.	Baseline, Week 12

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