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

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.

Study Overview

• Status: Terminated
• Conditions: Atopic Dermatitis (AD)
• Intervention / Treatment: Drug: OTC Drug for Atopic Dermatitis in Cream form

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Sequential Skin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Previously diagnosed Atopic Dermatitis with active, visible flare-ups at time of screening
• Present dry/itchy skin patches on forearm, back of the hand, or posterior lower leg 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Product
Experimental: Atopic Dermatitis OTC Product	Drug: OTC Drug for Atopic Dermatitis in Cream form; OTC Cosmetic Cream Formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin Microbiome Composition and Diversity using qPCR analysis	4 weeks
Trans-Epidermal Water Loss Measurement via Vapometer	4 weeks
Moisturizing effect by measurement of cutaneous hydration via MoistureMeterSC	4 weeks
Skin barrier lipid composition and integrity via lipidomic profiling analysis	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Before and After Treated Arm Itching Assessment	In vivo clinical grading by a technician using a 11 point scale (0 = uncomfortable, irritated, and 10 = comfortable, soothed)	4 weeks
Before and After Treated Arm Redness Assessment	In vivo clinical grading by a technician using a 5 point scale (0 = absence of redness, and 4 = severe intensity)	4 weeks
Before and After Treated Arm Skin Dryness Assessment	In vivo clinical grading by a technician using a 11 point scale (0 = dry, cracked skin, and 10 = well-hydrated skin)	4 weeks
Monitoring of Atopic Dermatitis/Eczema Severity	Via the Patient Oriented Eczema Measure (POEM) tool	4 weeks

Collaborators and Investigators

• Sponsor: Good Molecules, LLC
• Collaborators: Sequential Skin Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2025
• Primary Completion (Actual): May 12, 2026
• Study Completion (Actual): May 12, 2026

Study Registration Dates

• First Submitted: August 15, 2025
• First Submitted That Met QC Criteria: August 21, 2025
• First Posted (Actual): August 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Pharmaceutical Preparations; Nonprescription Drugs
• Other Study ID Numbers: SS-NLP-417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes