UHE-101 cream, 1% ("UHE-101") is being developed for the topical treatment of acne vulgaris. The purpose of this study is to compare the safety and efficacy of twice daily topical application of UHE-101 cream for 12 weeks to its vehicle cream in subjects with facial acne vulgaris.
The purpose of this study is to test a topical cream (UHE-101) containing 1.0% of active drug, for 12 weeks, in boys and girls, men and women, in the treatment of facial acne. Patients who qualify for this study will apply the study cream twice daily (once in the morning and once in the evening) for 12 weeks. Half of the patients in this study will receive UHE-101 cream and half will receive a vehicle cream that does not include an active drug (i.e., placebo). This is a double-blind study, which means that neither the patient nor the investigator will know which cream the patient is using. The study will last about 12 weeks and will involve 5 clinic visits.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Topical cream containing investigational drug at a concentration of 1%
Topical cream containing no drug (i.e., placebo)
Site 02
San Diego, California, United States
Investigator's Global Assessment (IGA) "Success"
Proportion of subjects achieving success in each treatment group at Week 12 using the dichotomized IGA with success defined as a score of "clear" or "almost clear" (IGA Score of 0 or 1) and a two or more grade improvement from Baseline.
Time frame: Week 12
Acne Lesion Counts (Absolute Change)
Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 12.
Time frame: Week 12
IGA "Success"
Proportion of subjects achieving success in each treatment group at Week 4.
Time frame: Week 4
IGA "Success"
Proportion of subjects achieving success in each treatment group at Week 8.
Time frame: Week 8
Acne Lesion Counts (Absolute Change)
Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 4.
Time frame: Week 4
Acne Lesion Counts (Absolute Change)
Absolute change from Baseline in Acne Lesion Counts in each treatment group at Week 8.
Time frame: Week 8
Acne Lesion Counts (Percent Change)
Percent change from Baseline in lesion counts in each treatment group at Week 4
Time frame: Week 4
Acne Lesion Counts (Percent Change)
Percent change from Baseline in lesion counts in each treatment group at Week 8
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Time frame: Week 8
Acne Lesion Counts (Percent Change)
Percent change from Baseline in lesion counts in each treatment group at Week 12
Time frame: Week 12