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PART 2 High-Dose for Atopic Dermatitis

Phase 2
Recruiting
Research Sponsored by Shaperon
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with 5% to 30% of total body surface area (BSA) affected by AD at screening and baseline visits
Subjects with a clinical diagnosis of AD according to the Hanifin and Rajka Criteria by a board certified/eligible dermatologist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 8
Awards & highlights

Study Summary

This trial is a study in patients with mild to moderate Atopic Dermatitis (AD) that will be conducted at multiple centers. It is a phase 2 study with two parts, and it will

Who is the study for?
Adults with mild to moderate Atopic Dermatitis (AD) can join this trial. They must have been diagnosed by a dermatologist at least 6 months ago, have AD affecting 5-30% of their body, and be able to consent. People are excluded if they don't meet these criteria.Check my eligibility
What is being tested?
The study is testing HY209GEL against a placebo in people with AD. It's randomized (participants are assigned randomly), double-blind (neither participants nor researchers know who gets what treatment), and placebo-controlled.See study design
What are the potential side effects?
Possible side effects aren't specified here but generally could include skin irritation, redness, or itching where the gel is applied. Since it's a test for safety and effectiveness, monitoring for any adverse reactions will be part of the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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5% to 30% of my skin is affected by atopic dermatitis.
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I have been diagnosed with atopic dermatitis by a dermatologist.
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I had Alzheimer's diagnosed over 6 months ago and have been stable for the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage change in Eczema Area and Severity Index (EASI) score

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: PART 2 High-DoseActive Control1 Intervention
Active group selected for PART1 as a high-dose
Group II: PART 2 Low-DoseActive Control1 Intervention
Active group selected for PART1 as a Low-dose
Group III: PART 2 PlaceboPlacebo Group1 Intervention
Placebo group

Find a Location

Who is running the clinical trial?

ShaperonLead Sponsor
5 Previous Clinical Trials
1,374 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different sites is this clinical trial being conducted?

"The current iteration of this study is ongoing at 4 sites, with physical centers in Encino, Towson, and New york among others. Opting for a site closest to you can reduce travel requirements during your potential involvement."

Answered by AI

Does this research include individuals aged 40 and above?

"To be considered for participation in this research study, individuals must be at least 18 years old but no older than 100."

Answered by AI

Am I eligible to be a participant in this clinical trial?

"This clinical trial aims to enroll 210 individuals aged between 18 and 100 with atopic dermatitis. In addition, participants must fulfill the subsequent conditions: Both male and female volunteers aged 18 years or above, Must possess a vIGA score of 2 or 3 indicating mild to moderate AD during screening and baseline assessments, Ability to provide written consent for participation, Confirmed diagnosis of AD based on Hanifin and Rajka Criteria by a board-certified/eligible dermatologist at least half a year before screening, Affected area by AD should range from minimum of 5% to maximum of 30% total body"

Answered by AI

Are potential participants currently able to enroll in this ongoing investigation?

"Indeed, information available on clinicaltrials.gov indicates that this current trial is actively seeking volunteers. The study was first listed on March 1, 2024, and most recently updated on April 24, 2024. A total of 210 participants are sought from four distinct locations."

Answered by AI

Has the high-dose regimen in Part 2 received approval from the FDA?

"Based on our assessment at Power, we assign a safety rating of 2 to PART 2 High-Dose. This evaluation stems from the trial being classified as Phase 2; hence, there exists preliminary safety data without confirmed efficacy outcomes yet."

Answered by AI
~140 spots leftby Oct 2025