Phase 4
N=26
A Study That Evaluates the Decrease in Irritation When Using Additional Acne Treatment Products
Acne Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT01313728 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcome: Primary: Expert Grader Assessment - Erythema — 0.0; 0.0; 0.4; 2.0 Scores on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Dapsone plus Tretinoin Gel (Drug); Tretinoin Gel (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Expert Grader Assessment - Erythema |
0.0; 0.0; 0.4; 2.0; 0.4; 2.0 | — |
| PRIMARY Expert Grader Assessment - Dryness |
0.0; 0.0; 0.6; 1.8; 1.7; 2.5 | — |
| SECONDARY Subject Assessment - Burning/Stinging |
1.0; 0.0; 2.6; 1.6; 1.8; 2.6 | — |
| SECONDARY Subject Assessment - Itching |
0.0; 0.0; 1.6; 2.8; 0.5; 1.9 | — |
| SECONDARY Subject Assessment - Tightness |
0.0; 0.0; 1.5; 1.8; 1.5; 2.9 | — |
| SECONDARY Facial Tolerance |
1.0; 0.0; 6.7; 10.0; 5.9; 11.9 | — |
Summary
This study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. All people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. If one side of the face is more irritated than the other side, a picture will be taken as well.
Eligibility Criteria
Inclusion Criteria
- Fitzpatrick Skin Type I, II or III with healthy skin as judged by the investigator
- Bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc., prior to study start
- Subjects are willing to avoid applying emollients or cosmetics to the face 24 hours before they start, and during the study
- If subject is of childbearing potential, subject has been using a protocol-approved method of birth control for a certain amount of time, and is willing to continue using it throughout the study
Exclusion Criteria
- Subjects who are pregnant or nursing, or intend to be during the study
- Subjects with any condition or medical history, or using any drug or medication, that might negatively affect the subject's safety or the validity of study results, either as listed in the protocol or in the opinion of the investigator
- Subjects who have facial hair that may obstruct or hinder the evaluation of any reactions
- Subjects who use any known photosensitizing agents
Data sourced from ClinicalTrials.gov (NCT01313728). 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.