Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis
Sponsor: Prime Gene Therapeutics Co., Ltd.
Summary
This is a Multicenter, Randomized, Double-blind, Placebo-controlled seamless and adaptive-designed phase IIb/III study to Assess the Efficacy and Safety of topical use of PG-011 Gel in adolescents and Adults With Atopic Dermatitis. It consists of phase IIb and phase III parts, phase IIb is a dose-ranging part and has been done, and phase III is a pivotal study part which is registered this time. The goal of this phase III clinical trial is to learn if PG-011gel works to treat mild to moderate Atopic Dermatitis in adolescents and adults by topical use. It will also learn about the safety of PG-011gel. Investigators will compare PG-011gel to a placebo (a look-alike substance that contains no drug) to see if PG-011gel works to treat mild to moderate Atopic Dermatitis. Participants will: * Use PG-011gel or a placebo twice daily for initial 8 weeks, and followed by using PG-011 gel for all of the participants till 52-week. * Visit the clinic at weeks 1, 2, 4 and 8 for checkups and tests, and followed by visiting the clinic every 4 weeks till 52-week. * Keep a diary of their symptoms.
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Study to Assess the Efficacy and Safety of PG-011 Gel With 8 Weeks Treatment and Extension Safety Study to 52 Weeks in Adolescents and Adults With Atopic Dermatitis
Key Details
Gender
All
Age Range
12 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
472
Start Date
2024-03-15
Completion Date
2026-01-15
Last Updated
2025-05-20
Healthy Volunteers
No
Conditions
Interventions
PG-011Gel
Twice daily for 52 weeks or 44 weeks
Vehicle
Vehicle Gel twice daily for 8 weeks
Locations (1)
The First Hospital of China Medical University
Shenyang, Liaoning, China