RecruitingPhase 3NCT06587685

A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis

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


Sponsor

Prime Gene Therapeutics Co., Ltd.

Enrollment

472 participants

Start Date

Mar 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called PG-011Gel and a drug called Vehicle for people with atopic dermatitis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPG-011Gel

Twice daily for 52 weeks or 44 weeks

DRUGVehicle

Vehicle Gel twice daily for 8 weeks


Locations(1)

The First Hospital of China Medical University

Shenyang, Liaoning, China

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NCT06587685


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