Phase 4
Completed N=28
A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne
Source: ClinicalTrials.gov NCT00964223 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Skin Dryness Score — 0.15; 0.46; 0.14; 0.29 Units on a scale
Summary
Multi-center, single-blind, randomized, comparative, split-face study. The duration of the study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Dryness Score |
0.15; 0.00 | — |
| PRIMARY Skin Peeling Score |
0.00; 0.00 | — |
| PRIMARY Irritant/Allergic Contact Dermatitis Score |
0.04; 0.00 | — |
| PRIMARY Erythema (Redness) Score |
0.26; 0.19 | — |
| SECONDARY Erythema (Redness) Score |
0.26; 0.19 | — |
| SECONDARY Skin Dryness Score |
0.15; 0.00 | — |
| SECONDARY Skin Peeling Score |
0.00; 0.00 | — |
| SECONDARY Irritant/Allergic Contact Dermatitis Score |
0.04; 0.00 | — |
| SECONDARY Investigator Static Global Assessment Score |
2.63; 2.15 | — |
| SECONDARY Inflammatory Acne Lesion Counts |
8.44; 7.00 | — |
| SECONDARY Non-Inflammatory Acne Lesion Counts |
14.37; 10.81 | — |
| SECONDARY Total Acne Lesion Counts |
22.81; 17.81 | — |
| SECONDARY Skindex-29 Quality of Life Questionnaire - Symptomatic Domain |
28.10; 21.72 | — |
| SECONDARY Skindex-29 Quality of Life Questionnaire - Emotional Domain |
44.29; 35.37 | — |
| SECONDARY Skindex-29 Quality of Life Questionnaire - Functional Domain |
14.06; 9.10 | — |
| SECONDARY Skindex-29 Quality of Life Questionnaire - Global Score |
14.06; 9.10 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Redness |
1.00 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Dryness |
1.22 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Burning |
0.63 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Itching |
0.63 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Scaling |
0.78 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Ease of Application of Product |
1.26 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Comfort of Skin |
1.78 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? |
17; 8; 12; 15 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Comparison of Study Products to Products Used in the Past |
1.93 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products |
2.07 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Compliance |
24; 3 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin |
24; 3 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment |
20; 7 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up |
1.89 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product |
2.52 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects at least 18 years of age, in good general health with documented diagnosis of facial acne vulgaris.
- Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
- Subjects willing to follow therapeutic instructions including avoidance of any other topical facial or systemic acne therapy during the conduct of the study.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
Exclusion Criteria
- Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- Subjects who have any clinically relevant finding at their baseline physical examination or medical history such as severe systemic diseases, diseases of the facial skin, other than acne vulgaris.
- Facial hair that may obscure the accurate assessment of acne grade.
- History or presence of regional enteritis or inflammatory bowel disease (e.g., ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- Use of topical antibiotics on the face and systemic antibiotics within the past 2 and 4 weeks, respectively.
- Use of topical corticosteroids on the face or systemic corticosteroids within the past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for facial acne lesions) steroids is acceptable.
- Use of systemic retinoids within the past 6 months.
- Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of increased phototoxicity.
- Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular blocking activities, which may enhance the action of other neuromuscular blocking agents.
- Use of topical anti-acne medications within the past 2 weeks.
- Use of any investigational drugs or treatments during the study or within 4 weeks of the baseline visit.
Data sourced from ClinicalTrials.gov (NCT00964223). 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.