Phase 4
Completed N=168
Evaluation of Quality of Life, Efficacy, and Tolerance of Duac® Gel Compared to Differin® Gel in the Treatment of Acne
Source: ClinicalTrials.gov NCT00807014 ↗Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Mar 2012
Primary outcomePrimary: Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire — -4.9; -1.1 scores on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Week 2 in the Global Score of the Participant-completed Skindex-29 Quality of Life (QoL) Questionnaire |
-4.9; -1.1 | <0.001 sig |
| SECONDARY Mean Change From Baseline to Week 12 for the Indicated Domain Scores and the Global Score of the Participant-completed Skindex-29 QoL Questionnaire |
-7.4; -2.8; -10.3; -5.4; -3.5; -0.1 | — |
| SECONDARY Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts |
-8.5; -6.3; -11.8; -8.2; -16.3; -9.1 | — |
| SECONDARY Mean Percent Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Inflammatory, Non-inflammatory, and Total Lesion Counts |
-29.8; -22.9; -38.4; -26.5; -52.6; -36.4 | — |
| SECONDARY Correlation Between Skindex-29 Questionnaire Scores and Total Lesion Counts From Baseline to Week 2 |
0.042; -0.094; 0.166; 0.002; 0.237; -0.137 | — |
| SECONDARY 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) |
5.2; 4.9; 5.4; 5.3; 5.7; 5.3 | — |
| SECONDARY Mean Scores for Self-evaluation of Acne Improvement at Weeks 1, 2, 4, 8, and 12 Compared to the Start of Treatment (Prior to Week 1) |
2.8; 2.5; 2.8; 2.7; 2.7; 2.7 | — |
| SECONDARY Mean Acne Grades at Baseline and Weeks 1, 2, 4, 8, and 12 Assessed by the Leeds Revised Acne Grading System |
2.7; 2.6; 2.4; 2.3; 2.0; 2.1 | — |
| SECONDARY Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Peeling, Erythema, and Dryness |
0.5; 0.8; 0.2; 0.6; 0.3; 0.6 | — |
| SECONDARY Mean Change From Baseline to Weeks 1, 2, 4, 8, and 12 in Tolerance Symptoms of Itching and Burning |
0.4; 0.9; 0.2; 0.7; 0.2; 0.7 | — |
| SECONDARY Number of Participants in the Indicated Categories for Overall Tolerance at Week 12/Early Termination |
0; 5; 4; 14; 42; 47 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT00807014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.