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ENROLLING_BY_INVITATIONPHASE3

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

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

NCT07146971•Good Molecules, LLC

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 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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (1)

Sequential Skin

New York, New York, United States

Key Dates

Start Date

August 28, 2025

Primary Completion Date

September 25, 2025

Completion Date

November 25, 2025

Last Updated

August 28, 2025

Enrollment

ESTIMATED participants

Conditions

Atopic Dermatitis (AD)

Interventions

OTC Drug for Atopic Dermatitis in Cream form

DRUG

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

NCT07298395

Atopic Dermatitis (AD)

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RECRUITINGPHASE1

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

NCT07235384

Atopic Dermatitis (AD)

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RECRUITINGNA

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Study of ENV-294 in Adults With Moderate-to-Severe Atopic Dermatitis

A Phase 1/1b Study to Evaluate Safety, Tolerability and Pharmacokinetics of ZL-1503 in Healthy Volunteers and Participants With Moderate to Severe Atopic Dermatitis

Effect of an Emollient Cream Containing a Milk Bioactive Peptide on Clinical Signs, Pruritus and Bacterial Colonization of Mild Atopic Dermatitis Skin Lesions in Pediatric Population

Herbal Ointment in Treating Atopic Dermatitis Topically

Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment with 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

Study of ENV-294 in Healthy Adults and in Adults With Moderate-to-Severe Atopic Dermatitis