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RECRUITING
NCT06587685
PHASE3

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

PG-011Gel

Twice daily for 52 weeks or 44 weeks

DRUG

Vehicle

Vehicle Gel twice daily for 8 weeks

Locations (1)

The First Hospital of China Medical University

Shenyang, Liaoning, China