Conditions: Acne Vulgaris
Keywords: Acne Irritation
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 26
Healthy volunteers: yes

Brief 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.

Detailed description:
This is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. All subjects will apply Retin-A Micro Gel (tretinoin) 0.1 % Pump, and Aczone Gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying Aczone Gel first) and Retin-A Micro Gel 0.1 % Pump to the other side of the face in a randomized scheme for two consecutive weeks. Subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). At each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. Subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. A single treatment center is expected to enroll at least 24 subjects.

Arms:
arm 1: Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model arm 2: Tretinoin gel applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model

Interventions: intervention 1: Dapsone plus Tretinoin Gel intervention 2: Tretinoin Gel
Intervention descriptions: intervention 1: Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks intervention 2: Tretinoin gel applied once daily to the assigned side of the face for 2 weeks

Protocol document: