Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne

NCT00807014 | Completed Phase 4 Results

• 2 other identifiers: 114567S194-SP-05/Duac
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 8

Brief Summary

The objectives of this clinical trial are to compare the quality of life of the subjects, the efficacy and the tolerance of Duac® Gel (gel formulation with a combination of clindamycin phosphate \[equivalent to 1% clindamycin\] and 5% benzoyl peroxide), applied once daily, against Differin® Gel (gel with 0.1% adapalene), used once daily, in the treatment of mild to moderate acne vulgaris.

Conditions

Acne Vulgaris

Keywords

Differin; quality of life; Acne; Duac; Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire

  Skindex-29 is a self-administered QoL questionnaire comprised of 29 items scored on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=often, 4=all the time) covering 3 domains: emotional (10 items), symptomatic (7 items), and functional (12 items), with domain scores ranging from 0 to 40, 28, and 48, respectively. Lower scores = better QoL. A Global Score (range 0-100) was derived by multiplying the sum of the points for all 29 items by a constant (0.862). Change from Baseline was calculated as the value at Week 2 minus the value at Baseline (Week 0).

  Baseline (Week 0) and Week 2

Secondary Outcomes (10)

• Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire

  Baseline (Week 0) and Week 12

• Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts

  Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12

• Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts

  Baseline (Week 0) and Weeks 1, 2, 4, 8, and 12

• Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2

  Baseline (Week 0) and Week 2

• Mean Scores for Global Change in Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1)

  Start of treatment and Weeks 1, 2, 4, 8, and 12

Study Arms (2)

Duac Gel

EXPERIMENTAL

Duac Gel

Drug: Duac Gel

Differin gel

ACTIVE COMPARATOR

Differin gel

Drug: Differin gel

Interventions

Duac Gel DRUG

Duac® Gel will be applied to the face once daily at night, for 12 weeks.

Also known as: Duac

Duac Gel

Differin gel DRUG

Differin Gel will be applied to the face once daily at night, for 12 weeks.

Also known as: Differin

Differin gel

Eligibility Criteria

• Age: 12 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subjects with mild to moderate acne vulgaris on the face,.
• Subjects of either sex aged between 12 and 39 years, inclusive.
• Subjects agreeing not to use sun-beds or undergo any UV light treatment for 4 weeks prior to entering the study and to minimize the amount of exposure to direct sunlight for the duration of the study.

You may not qualify if:

• Women who are pregnant, breast-feeding, or sexually active with the potential to have children, and not using a contraception method that is safe from a medical point of view
• Subjects using anti-androgen containing contraceptives.
• Subjects who, during the past month, have received oral or topical steroids or antibiotics, or acne treatment of any type, including natural or artificial UV therapy.
• Subjects who have a history of hypersensitivity or idiosyncratic reaction to clindamycin phosphate, benzoyl peroxide, adapalene or any components of the medicinal products which will be used during the study.
• Subjects using, or having used in the past month, any significant concomitant medicinal product which might affect their acne, as judged by the Investigator.
• Subjects with a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.
• Subjects with a history of photosensitivity.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (8)

Hospital Abente y Lago in La Coruna

A Coruña, Spain

Location

Hospital Germans Trias I Pujol

Badalona, 08916, Spain

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Universitario Ramón and Cajal

Madrid, 28034, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clínico Universitario Ntra. Sra. de the Victoria

Málaga, 29010, Spain

Location

Clínica Universitaria de Navarra

Pamplona, 31008, Spain

Location

Hospital Clínico de Salamanca

Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

clindamycin phosphate benzoyl peroxide combination; Adapalene

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 11, 2008
• Study Start: November 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: March 20, 2012
• Results First Posted: March 6, 2012

Record last verified: 2012-02

Locations

ES (8)