NCT03307577

A Phase 2 Safety and Efficacy Study of UHE-101 Cream in Subjects With Acne Vulgaris

A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Comparison Study to Evaluate the Safety and Efficacy of UHE-101 Cream 1% When Applied Twice Daily for 12 Weeks in Subjects With Facial Acne Vulgaris

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Therapeutics, Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
DRUG	UHE-101 Cream	Topical cream containing investigational drug at a concentration of 1%
OTHER	Vehicle Cream	Topical cream containing no drug (i.e., placebo)

Timeline

• Start date: 2017-10-05
• Primary completion: 2018-05-31
• Completion: 2018-05-31
• First posted: 2017-10-11
• Last updated: 2019-05-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study