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

NCT07146971 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SS-NLP-417
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Atopic Dermatitis (AD)

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Before and After Treated Arm Itching Assessment

  4 weeks

• Before and After Treated Arm Redness Assessment

  4 weeks

• Before and After Treated Arm Skin Dryness Assessment

  4 weeks

• Monitoring of Atopic Dermatitis/Eczema Severity

  4 weeks

Study Arms (2)

Atopic Dermatitis OTC Product

EXPERIMENTAL

Drug: OTC Drug for Atopic Dermatitis in Cream form

No Product

NO INTERVENTION

Interventions

OTC Drug for Atopic Dermatitis in Cream form DRUG

OTC Cosmetic Cream Formulation

Atopic Dermatitis OTC Product

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Good Molecules, LLC: lead
• Sequential Skin Inc.: collaborator

Study Sites (1)

Sequential Skin

New York, New York, 10013, United States

RECRUITING

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Nonprescription Drugs

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Central Study Contacts

Peca

CONTACT

718-902-6228; sibora@sequential.bio

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 28, 2025
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): September 25, 2026
• Study Completion (Estimated): November 25, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)