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.
12 years old≤ age ≤ 75 years old (including threshold), male or female.
Participants diagnosed of atopic dermatitis (AD) as defined by the Williams diagnostic criteria.
AD/eczema duration of at least 1 year for adults and 6 months for adolescents.
IGA score of 2 (mild) or 3 (moderate) at the screening day and day 1.
Participant has unstable course of AD (spontaneously improving or rapidly deteriorating).
Immunocompromised (e.g. lymphoma, acquired immunodeficiency syndrome, Wiskott-Aldrich syndrome).
Any other concomitant skin disorder(e.g. generalized erythroderma, Netherton syndrome, acne, psoriasis, urticaria, pigmentation or extensive scarring）, in the opinion of investigator, may interfere with the evaluation of AD lesions or compromise participant safety.
Participant with chronic or acute infection needs to be treated with systemic antibiotics, antiviral drugs, antiparasitic drugs, anti-antigenic animal drugs or antifungal drugs within 2 weeks before randomization.
Parallel
PG-011Gel
DrugTwice daily for 52 weeks or 44 weeks
Vehicle
DrugVehicle Gel twice daily for 8 weeks
Proportion of participants who achieved Eczema Area and Severity Index (EASI 75) at Week 8
Defined as ≥ 75% improvement in Eczema Area and Severity Index score. The EASI score ranges from 0 to 72, higher score indicates greater severity.
Key Secondary Outcome: Investigators Global Assessment (IGA) score of 0/1 at Week 8
Proportion of participants achieving Investigators Global Assessment (IGA) score of clear (0) or almost clear (1) with at least a 2-point decrease from baseline at Week 8.
Proportion change of eczema area and severity index (EASI) at each scheduled visit
Proportion change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.
Change of eczema area and severity index (EASI) score at each scheduled visit
Value change in the eczema area and severity index (EASI) total score from baseline at each scheduled visit. The EASI score ranges from 0 to 72, higher score indicates greater severity.
Change from baseline of Itch Numeric Rating Scale (NRS) at each scheduled visit
The Itch NRS is an assessment tool that participants used to report the intensity of their itch during a 24-hour recall period. The NRS score ranges from 0 to 10 points, higher score indicates greater intensity.
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