A Study to Assess the Efficacy and Safety of PG-011 Gel in Adolescents and Adults With Atopic Dermatitis
Recruiting
Phase 3
Interventional Study
Atopic Dermatitis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 12 – 75
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 472 (estimated)
- Sponsor
- Prime Gene Therapeutics Co., Ltd. · Industry
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About This Trial
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.
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Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 12 years old≤ age ≤ 75 years old (including threshold), male or female.
2. Participants diagnosed of atopic dermatitis (AD) as defined by the Williams diagnostic criteria.
3. AD/eczema duration of at least 1 year for adults and 6 months for adolescents.
4. IGA score of 2 (mil…
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