Atopic Dermatitis (AD)Phase 1NCT07146971
Clinical Evaluation of Skin Microbiome an Over-The-Counter (OTC) Drug for Atopic Dermatitis
A Phase 1 study testing OTC Drug for Atopic Dermatitis in Cream form in people with Atopic Dermatitis (AD), run by Good Molecules, LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis (AD)
- What is being tested?
- OTC Drug for Atopic Dermatitis in Cream form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2025to 12 May 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- General:
- Healthy subject apart from atopic dermatitis
- Subject having given free informed, written consent
- Subject willing to adhere to protocol and study procedures
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Atopic Dermatitis (AD)
- Being tested
- OTC Drug for Atopic Dermatitis in Cream form
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTC Drug for Atopic Dermatitis in Cream formDrug
OTC Cosmetic Cream Formulation
| Study group | Role | What they receive |
|---|---|---|
| Atopic Dermatitis OTC Product | Experimental | Not described Receives: Drug: OTC Drug for Atopic Dermatitis in Cream form |
| No Product | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Microbiome Composition and Diversity using qPCR analysis
Measured: 4 weeks
Trans-Epidermal Water Loss Measurement via Vapometer
Measured: 4 weeks
Moisturizing effect by measurement of cutaneous hydration via MoistureMeterSC
Measured: 4 weeks
Skin barrier lipid composition and integrity via lipidomic profiling analysis
Measured: 4 weeks
Secondary outcomes (4)
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)
Measured: 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)
Measured: 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)
Measured: 4 weeks
Monitoring of Atopic Dermatitis/Eczema Severity
Via the Patient Oriented Eczema Measure (POEM) tool
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start14 Aug 2025
- Primary completion12 May 2026
- Study completion12 May 2026
Why it stopped: We have decided to close the study due to recruitment challenges.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic Dermatitis (AD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Good Molecules, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sequential Skin Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07146971
- Sponsor's protocol ID
- SS-NLP-417
- Status last verified
- May 2026
- First submitted
- 15 Aug 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Skin Microbiome and the Efficacy of an Over-The-Counter (OTC) Drug for Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT07146971
- Acronym / sponsor ID
- SS-NLP-417
- Conditions
- Atopic Dermatitis (AD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We have decided to close the study due to recruitment challenges.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Good Molecules, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Sequential Skin Inc.
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 12 May 2026 (actual)
- Study completion
- 12 May 2026 (actual)
- First posted
- 28 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atopic Dermatitis OTC Product | Experimental | Drug: OTC Drug for Atopic Dermatitis in Cream form |
| No Product | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTC Drug for Atopic Dermatitis in Cream formOTC Cosmetic Cream Formulation | Drug | Atopic Dermatitis OTC Product |
Primary outcome
Skin Microbiome Composition and Diversity using qPCR analysis
Time frame: 4 weeks
Trans-Epidermal Water Loss Measurement via Vapometer
Time frame: 4 weeks
Moisturizing effect by measurement of cutaneous hydration via MoistureMeterSC
Time frame: 4 weeks
Skin barrier lipid composition and integrity via lipidomic profiling analysis
Time frame: 4 weeks
4 secondary outcomes
Before and After Treated Arm Itching Assessment
Time frame: 4 weeks
Before and After Treated Arm Redness Assessment
Time frame: 4 weeks
Before and After Treated Arm Skin Dryness Assessment
Time frame: 4 weeks
Monitoring of Atopic Dermatitis/Eczema Severity
Time frame: 4 weeks
Results and safety
The study was stopped early (reason given: We have decided to close the study due to recruitment challenges.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OTC Drug for Atopic Dermatitis in Cream form in people with Atopic Dermatitis (AD), run by Good Molecules, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: We have decided to close the study due to recruitment challenges.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin Microbiome Composition and Diversity using qPCR analysis (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.