How a daily moisturizer affects skin barrier, hydration, and microbiome in adults with sensitive skin
Official title: An Exploratory Clinical Investigation of a Topical Moisturizer on Skin Barrier Function, Inflammatory Biomarkers, and Skin Microbiome in Adults With Sensitive Skin
Run by Good Molecules, LLC · NCT07811531 · Data updated 2026-11-12
This study tests whether a labeled daily moisturizer improves skin barrier function and related skin health measures in adults with sensitive skin, using a paired comparison on each person against standard petrolatum.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Good Molecules, LLC Industry-sponsored |
| Drugs / interventions | dupilumab, lebrikizumab, tralokinumab, methotrexate |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | September 14, 2026 |
| Main results expected | December 16, 2026 |
| Study ends | January 12, 2027 |
| Registry record updated | September 10, 2026 |
| Trial ID | NCT07811531 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18-55 with self-described sensitive skin and a TEWL of at least 15 g/m2/h on the forearm at screening.
✕Probably not a fit
Individuals whose skin does not respond to moisturizers or who do not show measurable barrier or biomarker changes may not experience benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, randomized, evaluator-blinded, contralateral-controlled interventional study enrolling adults with sensitive skin. Each participant uses an investigational moisturizer on one forearm and white petrolatum on the opposite forearm for 28 days, following a 7-day washout. The study assesses changes in skin barrier function, hydration, inflammatory biomarkers, and skin microbiome, with 24 planned participants and a minimum of 20 evaluable. Participants serve as their own controls to compare outcomes between the two treatments. Primary endpoints focus on barrier measurements and biomarkers to gauge potential benefits of the investigational moisturizer.
Why it matters
Potential benefit: If successful, the investigational moisturizer could improve skin barrier function and overall skin health for people with sensitive skin.
How similar studies have gone: Previous studies in similar topical comparisons have shown that moisturizers can influence barrier function and hydration, though results vary by product and population.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18 to 55 years, inclusive, of any sex. * Self-declared sensitive skin affecting the body, characterized by unpleasant sensations such as burning, stinging, itching, tingling, tightness, or irritation in response to products or environmental triggers. * Must present a TEWL value ≥15 g/m2/h on a volar forearm at the screening visit (T-7). * Approximately 40-60% of enrolled participants should have Fitzpatrick skin types I-III, and approximately 40-60% should have Fitzpatrick skin types IV-VI. * Must agree to complete a minimum 7-day washout period prior to baseline. * Must agree to avoid body skincare products, moisturizers, hydrating gels, or prohibited topical products on both forearms during washout. * Must agree to use sponsor-provided SPF 30 sunscreen on both forearms beginning at least 7 days before baseline and continuing throughout study participation. * Must be willing and able to comply with all study requirements, including clinic visits, product use, questionnaires, and sample collection procedures. * Must provide written informed consent prior to any study-specific procedure. * Must be willing to apply study products twice daily (morning and evening) for 28 consecutive days and maintain diary compliance. Exclusion Criteria: * Pregnancy, breastfeeding, or planning pregnancy during the study. * Active dermatologic disease on the forearms, visible scars, or tattoos that interfere with measurement. * History of chronic inflammatory or autoimmune conditions (rheumatoid arthritis, lupus, psoriasis, IBD, ankylosing spondylitis, multiple sclerosis). * Active cancer or cancer treatment within the past 5 years, with the exception of localized non-melanoma skin cancer. * Diagnosis of primary or acquired immunodeficiency. * Use of systemic corticosteroids (oral or injected) within 4 weeks pre-enrollment, or anticipated use during the study. * Use of biologics for inflammatory conditions within 12 weeks pre-enrollment (including TNF inhibitors, IL-17 inhibitors, IL-23 inhibitors, IL-4/IL-13 inhibitors, dupilumab, lebrikizumab, tralokinumab, JAK inhibitors, and IL-1 blockers). * Use of systemic immunosuppressants within 8 weeks pre-enrollment (methotrexate, cyclosporine, mycophenolate, azathioprine, systemic tacrolimus). * Use of systemic antibiotics within 4 weeks pre-enrollment, or anticipated use during the study. * Regular use of oral NSAIDs (defined as more than 2 days per week on average) within 2 weeks pre-enrollment or anticipated regular use during the study. Occasional use for acute conditions is permitted with logging. * Daily aspirin use, including low-dose aspirin for cardiovascular prophylaxis. * Use of topical corticosteroids, calcineurin inhibitors, or other prescription anti- inflammatory topicals on the forearms within 4 weeks pre-enrollment. * Use of topical retinoids, alpha hydroxy acids, beta hydroxy acids, or other active exfoliants on the forearms within 4 weeks pre-enrollment. * Active smoking (including vaping and recent cessation within 6 months). * Heavy alcohol use, defined as more than 8 drinks per week. * Surgery under general anaesthesia within the past 4 weeks. * Vaccination within 2 weeks pre-enrollment. * Excessive UV exposure (sunbathing, tanning beds) within 4 weeks pre-enrollment. * Enrolled in another clinical trial within the 4 weeks pre-enrollment or during the study period.
Where it's running
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Sequential Skin
New York, New York, United States Recruiting
Study contacts
- Study coordinator: Dashi, PhD
- Email: clinical@sequential.bio
- Phone: +1 (646) 663-5260
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.