A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of HY209 Gel in Patients With Mild to Moderate Atopic Dermatitis(AD)

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a randomized, double-blind, placebo-controlled, multi-center, phase 2 study in patients with mild to moderate Atopic Dermatitis(AD), which consists of 2 parts.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• Male or female subjects aged 18 or older

• Subjects who have a history of AD at least 6 months ago from screening and have been clinically stable for ≥ 1 month

• Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist

• Subjects who have a minimum of 5% and a maximum of 30% of total body surface area (BSA) affected by AD at screening and baseline visits

• Subjects with vIGA score 2 or 3 corresponding to mild to moderate AD at screening and baseline visit

• Subjects should be a literate person who can read the participant information sheet and consent form/questionnaire and understand the language of the participation

Locations
United States
Alabama
Cahaba Dermatology Skin Health Center
RECRUITING
Birmingham
California
RAOOF MD Dermatology
RECRUITING
Encino
Maryland
Continental Clinical Solutions, LLC
RECRUITING
Towson
New York
Sadick Dermatology
RECRUITING
New York
Contact Information
Primary
Shaperon Shaperon
seoh@shaperon.com
82-2-6083-8315
Backup
Shaperon Shaperon
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 210
Treatments
Active_comparator: PART 2 High-Dose
Active group selected for PART1 as a high-dose
Active_comparator: PART 2 Low-Dose
Active group selected for PART1 as a Low-dose
Placebo_comparator: PART 2 Placebo
Placebo group
Related Therapeutic Areas
Sponsors
Leads: Shaperon

This content was sourced from clinicaltrials.gov

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