A Clinical Investigation of a Topical Moisturizer on Skin Barrier Function in Adults With Sensitive Skin
Purpose
The purpose of this research study is to evaluate whether a marketed moisturizing cream can improve skin barrier function (how well the outer layer of the skin keeps moisture in and protects the skin), skin hydration, skin sensitivity, inflammatory biomarkers (proteins in the skin that can provide information about inflammation), and the skin microbiome (the microorganisms that naturally live on the skin) in adults with sensitive skin, when compared with a commonly used moisturizing ointment (White Petrolatum) a widely used occlusive ointment (an ointment that forms a protective layer over the skin to help reduce moisture loss).
Condition
- Sensitive Skin
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
- Masking Description
- This study uses a within-subject randomized contralateral design. Each participant receives both treatments simultaneously. Treatment allocation to left or right forearm will be determined using a computer-generated randomization schedule prepared by designated unblinded study personnel. Randomization assignments will be securely stored.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator Occlusive comparator control |
White Petrolatum, USP |
|
|
Experimental Investigational moisturizer |
Marketed Moisturizer |
|
Recruiting Locations
New York, New York 10001
More Details
- Status
- Recruiting
- Sponsor
- Good Molecules, LLC
Detailed Description
This study is an exploratory, single-center, randomized, evaluator-blinded, contralateral-controlled clinical investigation designed to evaluate the effects of a sponsor-provided daily moisturizer on skin barrier function, hydration, inflammatory biomarkers, and skin microbiome composition in adults with sensitive skin. A total of 24 participants will be recruited, with a minimum of 20 participants expected to complete the study and be included in evaluable analyses. Participants will undergo a 7-day washout period followed by a 28-day treatment phase. Each participant will serve as their own control. One volar forearm will receive the investigational moisturizer and the contralateral forearm will receive an occlusive comparator control, White Petrolatum, USP.