Phase 4
N=52
Two-week Study to Compare the Tolerance and Irritation Potential of Two Combination Topical Gel Acne Medications
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00926367 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Skin Erythema (Redness) — 1.56; 1.89; 2.62; 2.65 Units on a scale — p=>0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clindamycin and benzoyl peroxide (Drug); benzoyl peroxide 2.5% and adapalene 0.1% gel (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stiefel, a GSK Company
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Erythema (Redness) |
1.56; 1.89; 2.62; 2.65; 2.90; 2.52 | >0.05 |
| PRIMARY Skin Dryness |
0.12; 0.07; 0.41; 0.25; 0.32; 0.34 | >0.05 |
| SECONDARY Skin Moisture and Hydration |
11.50; 13.07; 11.38; 15.85; 14.51; 21.65 | — |
| SECONDARY Skin Hydration |
378.06; 392.09; 323.47; 415.90; 420.97; 465.25 | — |
| SECONDARY Self Assessment of Burning |
0.00; 0.00; 0.04; 0.04; 0.04; 0.04 | — |
| SECONDARY Self Assessment of Stinging |
0.00; 0.00; 0.08; 0.00; 0.08; 0.00 | — |
| SECONDARY Self Assessment of Dryness |
0.24; 0.30; 0.2; 0.19; 0.16; 0.15 | — |
| SECONDARY Self Assessment of Texture (Roughness) |
0.28; 0.15; 0.20; 0.07; 0.16; 0.07 | — |
| SECONDARY Self Assessment of Pain |
0.00; 0.00; 0.04; 0.04; 0.04; 0.00 | — |
| SECONDARY Self Assessment of Crusting |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Self Assessment of Blistering |
0.00; 0.00; 0.00; 0.00; 0.00; 0.00 | — |
| SECONDARY Self Assessment of Oiliness |
0.12; 0.19; 0.08; 0.11; 0.00; 0.04 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - How do You Rate the Comfort of the Skin Where You Are Currently Treating With the Study Product? |
2.38; 2.23 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - How Compliant Were You With Applying the Study Product Each and Every Day? |
2.00; 2.00 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Did You Feel That Your Skin Was Hydrated and Moisturized While You Were on Your Study Product? |
0.58; 0.54 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - Was the Study Product Easy to Use With Make-up? |
1.04; 1.46 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - What Was Your Overall Satisfaction of the Study Product? |
2.29; 2.46 | — |
| SECONDARY Product Acceptability and Preference Questionnaire - How do You Rate the Ease of Application of the Study Product? |
1.17; 1.00 | — |
Summary
This is a single-blind (blinded expert grader), randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, antibiotic and benzoyl peroxide or benzoyl peroxide and adapalene gel and the contra lateral side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects will be randomly assigned to each product
Eligibility Criteria
Inclusion Criteria
- Subjects 18 to 45 years of age or older, able to complete the study and comply with study instructions.
- Female subjects of childbearing potential must have a negative pregnancy test. Sexually active women of childbearing potential participating in the study must have been using a medically acceptable form of contraception
- 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.
- Is willing to discontinue use of all facial products (other than the cleanser provided and makeup or razor and facial shave product) on the face for the 3 days before their baseline/day 0 visit and use only the provided facial products and their normal makeup or razor and facial shaving product for the duration of the study.
- Is willing to avoid sunburn, tanning, tanning beds or other excessive sun exposure. Understands that if their skin tone changes significantly during the study it will be necessary to discontinue their participation.
Exclusion Criteria
- Male subjects that have facial beards (mustache and/or goatee is acceptable).
- Is a Type I diabetic.
- Has active or chronic skin allergies.
- Has a history of acute or chronic disease that might interfere with, or increase the risk of study participation.
- Has participated in other facial studies in the preceding 30 days or other clinical studies in preceding 14 days.
- Had skin cancer treatment in preceding 12 months.
- Has damaged skin on facial areas (eg, from sunburn, tattoos, scars).
- Had any medical procedure (eg, laser resurfacing, chemical peels, plastic surgery) to facial areas in preceding 12 months.
- Had any cosmetic procedure (eg, microdermabrasion, etc.) to facial areas within 8 weeks of the baseline visit.
- Live in the same household as currently enrolled subjects.
- Any other condition or factor the investigator or his duly assigned representative believes may affect the skin response or the interpretation of the test results.
Data sourced from ClinicalTrials.gov (NCT00926367). 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.