ClinicalTrials.gg
TerminatedNCT07146971Updated May 27, 2026

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

A Phase 1 interventional study of OTC Drug for Atopic Dermatitis in Cream form in Atopic Dermatitis (AD), sponsored by Good Molecules, LLC. Terminated at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-27.

Sponsored by Good Molecules, LLC · Phase 1, Interventional, and Treatment

Why this study was terminated
We have decided to close the study due to recruitment challenges.
Phase
Phase 1
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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Conditions studied

  • Atopic Dermatitis (AD)

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In context

Dermatitis, Atopic

1,591 studies on the registry are indexed under Dermatitis, Atopic; 286 are open to participants now.

This study's enrollment of 3 is below the median of 82 across 1,246 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Good Molecules, LLC is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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, , 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
3 participants (actual)

Study arms

  • Experimental
    Atopic Dermatitis OTC Product

    Drug: OTC Drug for Atopic Dermatitis in Cream form

  • No intervention
    No Product

Interventions

  • DrugOTC Drug for Atopic Dermatitis in Cream form

    OTC Cosmetic Cream Formulation

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What researchers measure

Primary outcomes

  1. Skin Microbiome Composition and Diversity using qPCR analysis

    Time frame: 4 weeks

  2. Trans-Epidermal Water Loss Measurement via Vapometer

    Time frame: 4 weeks

  3. Moisturizing effect by measurement of cutaneous hydration via MoistureMeterSC

    Time frame: 4 weeks

  4. Skin barrier lipid composition and integrity via lipidomic profiling analysis

    Time frame: 4 weeks

Secondary outcomes

  1. 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)

    Time frame: 4 weeks

  2. 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)

    Time frame: 4 weeks

  3. 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)

    Time frame: 4 weeks

  4. Monitoring of Atopic Dermatitis/Eczema Severity

    Via the Patient Oriented Eczema Measure (POEM) tool

    Time frame: 4 weeks

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Study locations

1 site
  • Sequential Skin
    New York, New York 10013, United States
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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07146971
Lead sponsor
Good Molecules, LLC
Collaborators
Sequential Skin Inc.
Responsible party
Sponsor
First posted
Aug 28, 2025
Start date
Aug 14, 2025
Primary completion
May 12, 2026
Completion
May 12, 2026
Last update
May 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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