Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis

Good Molecules, LLC

Status and phase

Invitation-only

Phase 3

Conditions

Atopic Dermatitis (AD)

Treatments

Drug: OTC Drug for Atopic Dermatitis in Cream form

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT07146971

SS-NLP-417

Details and patient eligibility

About

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 study, the investigators will analyze the participants' skin microbiome, measure skin hydration and barrier function, and assess clinical improvements to help us understand the potential impact of the investigational OTC drug on atopic dermatitis and skin microbiome balance.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 criteria

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