Status:
ENROLLING_BY_INVITATION
Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis
Lead Sponsor:
Good Molecules, LLC
Collaborating Sponsors:
Sequential Skin Inc.
Conditions:
Atopic Dermatitis (AD)
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is a research study. The over-the-counter (OTC) drug for atopic dermatitis being tested is not approved as a treatment for the participants' atopic dermatitis condition. In participating in this ...
Eligibility Criteria
Inclusion
- Previously diagnosed Atopic Dermatitis with active, visible flare-ups at time of screening
- Present dry/itchy skin patches on forearms suitable for treatment assessment
- Evidence of inflammatory disease (documented diagnosis and current active symptoms)
- Stable skincare routine for 4 weeks prior to screening
- Subject willing to avoid conflicting topical treatments during study period
- Subject being used to applying topical treatments for atopic dermatitis
- General:
- Healthy subject apart from atopic dermatitis
- Subject having given free informed, written consent
- Subject willing to adhere to protocol and study procedures
Exclusion
- Pregnant or nursing woman or woman planning to get pregnant during the study
- Recent (within 4 weeks) or current history of using atopic dermatitis biological drugs, such as dupilumab, lebrikizumab, nemolizumab, and tralokinumab
- Recent use of systemic antibiotics, steroids, or immunomodulators (within 4 weeks)
- Active skin infections unrelated to atopic dermatitis
- Severe dermatologic conditions requiring immediate medical intervention
- Use of topical or systemic treatment during previous weeks liable to interfere with assessment
- Subject having undergone surgery under general anaesthesia within the previous month
- Excessive exposure to sunlight or UV-rays within the previous month
- Subject having scars, tattoos on the forearms that would interfere with assessments
- Subject enrolled in another clinical trial during the study period and/or during the past 30 days
Key Trial Info
Start Date :
August 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 25 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT07146971
Start Date
August 28 2025
End Date
November 25 2025
Last Update
August 28 2025
Active Locations (1)
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1
Sequential Skin
New York, New York, United States, 10013