Clinical Evaluation of Skin Microbiome an Over-The-Counte... | NCT07146971

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

NCT07146971

Sponsor

Good Molecules, LLC

Status

Terminated

Last Update Posted

May 27, 2026Actual

Enrollment

3Actual

Phase

Phase 1

Conditions

Atopic Dermatitis (AD)

Interventions

OTC Drug for Atopic Dermatitis in Cream form

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

We have decided to close the study due to recruitment challenges.

Expanded Access Info

Start Date

Aug 14, 2025Actual

Primary Completion Date

May 12, 2026Actual

Completion Date

May 12, 2026Actual

First Submitted Date

Aug 15, 2025

First Submission Date that Met QC Criteria

Aug 21, 2025

First Posted Date

Aug 28, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2026

Last Update Posted Date

May 27, 2026Actual

Name	Class
Sequential Skin Inc.	UNKNOWN

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Label	Type	Description	Intervention Names
Atopic Dermatitis OTC Product	Experimental		Drug: OTC Drug for Atopic Dermatitis in Cream form
No Product	No Intervention

Name	Type	Description	Arm Group Labels	Other Names
OTC Drug for Atopic Dermatitis in Cream form	Drug	OTC Cosmetic Cream Formulation	Atopic Dermatitis OTC Product

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012873	Skin Diseases, Genetic
D030342	Genetic Diseases, Inborn
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D003872	Dermatitis