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

NCT ID: NCT07146971

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-28
• Study Completion Date: 2025-11-25

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Atopic Dermatitis OTC Product

Group Type: EXPERIMENTAL

OTC Drug for Atopic Dermatitis in Cream form

Intervention Type: DRUG

OTC Cosmetic Cream Formulation

No Product

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

OTC Drug for Atopic Dermatitis in Cream form

OTC Cosmetic Cream Formulation

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sequential Skin Inc.

UNKNOWN

Sponsor Role: collaborator

Good Molecules, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sequential Skin

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

SS-NLP-417

Identifier Type: -

Identifier Source: org_study_id