Phase 4
N=48
A Comparative Study of the Tolerability of Two Combination Therapies for the Treatment of Acne
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00887484 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Erythema (Redness) — 0.66; 0.91; 0.55; 0.74 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- BENZOYL PEROXIDE/ CLINDAMYCIN (Drug); BENZOYL PEROXIDE/ ADAPALENE (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Stiefel, a GSK Company
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Erythema (Redness) |
0.22; 0.19 | — |
| PRIMARY Skin Dryness |
0.47; 0.96; 0.40; 0.64 | — |
| PRIMARY Skin Peeling |
0.13; 0.06 | — |
| PRIMARY Irritant/Allergic Contact Dermatitis |
0.00; 0.00 | — |
| SECONDARY Erythema (Redness) |
0.22; 0.19 | — |
| SECONDARY Skin Dryness |
0.47; 0.96; 0.40; 0.64 | — |
| SECONDARY Skin Peeling |
0.13; 0.06 | — |
| SECONDARY Irritant/Allergic Contact Dermatitis |
0.00; 0.00 | — |
| SECONDARY Investigators Static Global Assessment |
2.77; 1.89; 1.62 | — |
| SECONDARY Total Acne Lesion Counts |
39.06; 15.96; 13.77 | — |
| SECONDARY Inflammatory Acne Lesion Counts |
14.23; 4.60; 4.26 | — |
| SECONDARY Non-inflammatory Acne Lesion Counts |
24.83; 11.36; 9.51 | — |
| SECONDARY Skindex-29 Quality of Life Questionnaire (QoL) - Symptomatic Domain |
20.91; 21.58; 13.75 | — |
| SECONDARY Quality of Life Questionnaire - Emotional Domain |
25.32; 19.38; 16.42 | — |
| SECONDARY Quality of Life Questionnaire - Functional Domain |
8.59; 6.30; 5.19 | — |
| SECONDARY Quality of Life Questionnaire - Global Score |
8.59; 6.30; 5.19 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Redness at Weeks 1 and 2 |
1.09; 1.72; 0.72; 1.15 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Redness at Week 8 |
0.77 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Dryness at Weeks 1 and 2 |
1.30; 1.81; 1.00; 1.41 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Dryness at Week 8 |
0.64 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Burning at Weeks 1 and 2 |
0.91; 1.68; 0.72; 1.30 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Burning at Week 8 |
0.36 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Itching at Weeks 1 and 2 |
0.64; 1.02; 0.72; 0.93 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Itching at Week 8 |
0.26 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Scaling at Weeks 1 and 2 |
0.79; 1.43; 0.59; 1.04 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Severity of Scaling at Week 8 |
0.45 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Ease of Application of Product at Weeks 1 and 2 |
1.30; 1.32; 1.35; 1.39 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Ease of Application of Product at Week 8 |
1.26 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Comfort of Skin at Weeks 1 and 2 |
2.81; 3.15; 2.39; 2.67 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Comfort of Skin at Week 8 |
1.83 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Which Study Product is Subject More Satisfied With? at Weeks 1 and 2 |
15; 30; 2; 16; 29; 1 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Comparison of Study Products Used in the Past at Week 8 |
1.63 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Weeks 1 and 2 |
1.87; 2.04; 1.85; 2.00 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Decrease of Acne Breakouts by Study Products at Week 8 |
1.53 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Compliance at Weeks 1 and 2 |
1.91; 1.91; 1.85; 1.85 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Compliance at Week 8 |
43; 3 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Weeks 1 and 2 |
16; 12; 31; 35; 14; 11 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Feeling of Hydrated and Moisturized Skin at Week 8 |
28; 18 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 1 and 2 |
44; 26; 3; 21; 39; 32 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Use of Study Product if Choice to Continue Acne Treatment at Week 8 |
41; 5 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Ease of Use Wtih Make-Up at Weeks 1 and 2 |
2.23; 2.31; 1.75; 1.75 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Ease of Use With Make-Up at Week 8 |
1.69 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Weeks 1 and 2 |
2.09; 2.23; 1.76; 1.98 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Overall Satisfaction of Study Product at Week 8 |
1.61 | — |
Summary
The purpose of this study is to compare the tolerability of topical combination therapies in the treatment of facial acne.
Eligibility Criteria
Inclusion Criteria
- Male or female subjects at least 21 years of age, in good general health with documented diagnosis of acne vulgaris.
- Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception Abstinence is considered an acceptable method of contraception.
- Inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) facial lesions.
- The ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study
- Capable of understanding and willing to provide signed and dated written voluntary informed consent (and any local or national authorization requirements) 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 other than acne vulgaris.
- History or presence of regional enteritis or inflammatory bowel disease (eg, ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of antibiotic-associated colitis) or similar symptoms.
- Use of topical antibiotics or anti-acne medications 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.
- Facial procedures performed by an esthetician, beautician, physician, nurse, or other practitioner, within the past 4 weeks or during the conduct of the study.
- Known hypersensitivity or previous allergic reaction to any of the active components, lincomycin, adapalene, clindamycin, benzoyl peroxide or excipients of the study product.
Data sourced from ClinicalTrials.gov (NCT00887484). 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.