Recruiting

Moisturizing CreamA Clinical Investigation of a Topical Moisturizer on Skin Barrier Function in Adults With Sensitive Skin

Sponsor:

Good Molecules, LLC

Code:

NCT07811531

Conditions

Sensitive Skin

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

White petrolatum

Investigational moisturizer

Study Details

Brief summary:

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).

Conditions

Sensitive Skin

Study ID

NCT07811531

Start date

Sep 14, 2026

Status verified date

Sep, 2026

Completion date

Jan 12, 2027

Anticipated

Primary completion date

Dec 16, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Occlusive comparator control

White Petrolatum, USP

experimental: Investigational moisturizer

Marketed Moisturizer

Interventions

White petrolatum

Dose per Application: 6 full pumps per application to the assigned forearm.

Investigational moisturizer

Dose per Application: 6 full pumps per application to the assigned forearm.

Primary outcome measure

Transepidermal Water Loss (TEWL) [ Time Frame: Baseline and Day 28 ]
Skin Hydration [ Time Frame: Baseline and Day 28 ]
Skin Surface pH [ Time Frame: Baseline and Day 28 ]
Protein Biomarkers [ Time Frame: Baseline and Day 28 ]
Skin Microbiome [ Time Frame: Baseline and Day 28 ]
Sensitive Scale-10 Questionnaire [ Time Frame: Baseline and Day 28 ]

Central Contacts and Locations

Central contacts

Dashi, PhD

+1 (646) 663-5260 clinical@sequential.bio

Locations

Sequential Skin

Recruiting

New York, New York, United States, 10001

Contacts

Dashi, PhD

+1 (646) 663-5260 clinical@sequential.bio

More Information

Sponsor

Good Molecules, LLC

Last update posted

Sep 10, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-11. This information was provided to ClinicalTrials.gov by Good Molecules, LLC on 2026-09-10.