Skin Study Center
Broomall, Pennsylvania, 19008, United States
NCT Number: NCT00952523
A study to compare the skin irritation potential of two marketed gels for acne treatment, each applied to half of the face of healthy volunteers.
Looking for future studies?
Notify Me18 year–45 year
All sexes
Interventional
Phase 4
Broomall, Pennsylvania, 19008, United States
At the Baseline Visit, following satisfaction of entry criteria and screening procedures, all subjects will be applying two products to their faces, each on one side only. The side of the face receiving each product is randomly assigned. One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
Subjects will return to the study center every weekday morning for evaluation and application of both study products. Applications done on the weekends, will be done at home by the subject. At each visit the subject will be scored for cutaneous treatment effects by a blinded evaluator. At baseline and at the end of each week, subjects will be photographed and have chromometer readings.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A marketed facial gel containing Tretinoin 0.04% is applied to one side of the face daily for three weeks.
Other names: Retin-A Micro Gel 0.04% Pump
A marketed facial gel containing Adapalene .1% and Benzoyl peroxide 2.5% is applied to the other side of the face daily for three weeks
Other names: Epiduo Gel
Time frame: three weeks
Scores on a scale were recorded each weekday. The scale for Erythema and Dryness was from 0=none to 8=severe (highest possible score is calculated as 8x5daysx3weeks=120). The scale for Burning/Stinging and Itching was from 0=none to 3=severe (highest possible score was calculated as 3x5daysx3weeks=45). The scores that were accumulated through the study for each treatment were then compared.
Bausch Health Americas, Inc.
Industry
An Investigator-Blind, Phase 4 Study Assessing the Facial Irritation Potential of Two Acne Treatment Products (Retin-A Micro Gel, 0.04% Pump and Epiduo Gel) Using a Split-Face Model
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05080764
Acne Vulgaris, Acneiform Eruptions
Fountain Valley, California, United States
View Trial DetailsNCT07652112
Acne Vulgaris, Acneiform Eruptions
Kayseri, Turkey (Türkiye)
View Trial DetailsNCT06415279
Acne Vulgaris, Acneiform Eruptions
High Point, North Carolina, United States
View Trial DetailsNCT07244887
Acne Vulgaris, Acneiform Eruptions
Istanbul, Turkey (Türkiye)
View Trial Details