OTC cream targeting the skin microbiome for atopic dermatitis
Clinical Evaluation of the Skin Microbiome and the Efficacy of an Over-The-Counter (OTC) Drug for Atopic Dermatitis
This trial will try an over-the-counter cream to see if it reduces symptoms and improves skin microbiome balance in people with active atopic dermatitis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Good Molecules, LLC Industry-sponsored |
| Drugs / interventions | dupilumab, lebrikizumab, nemolizumab, tralokinumab |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT07146971 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional study gives an over-the-counter topical cream to participants with active atopic dermatitis and monitors safety and preliminary effects. Investigators will collect skin microbiome samples, measure skin hydration and barrier function, and record clinical signs and symptoms over the treatment period. Eligible participants have visible, active AD flares on forearm, hand, or lower leg and must avoid other conflicting topical treatments during the study. The trial is conducted at Sequential Skin in New York with sponsor Good Molecules, LLC.
Who should consider this trial
Good fit: Ideal candidates are people with a prior diagnosis of atopic dermatitis who have active, visible flares on accessible sites (forearm, back of hand, or lower leg), use topical AD treatments routinely, and can follow study visit and treatment restrictions.
Not a fit: Patients who are pregnant or nursing, those on recent systemic antibiotics or biologic AD therapies, or those without active visible lesions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the cream could provide an accessible topical option that reduces flare severity and helps restore a healthier skin microbiome balance.
How similar studies have performed: Early-phase and small-scale studies of microbiome-directed topical approaches have shown some promising but preliminary improvements in AD symptoms and microbial balance, so the approach is promising but still experimental.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New York, New York
- Sequential Skin — New York, New York, United States (Recruiting)
Study contacts
- Study coordinator: Peca
- Email: sibora@sequential.bio
- Phone: 718-902-6228
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.