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

NCT07811531 | Recruiting Phase 4 FDA Drug

• 1 other identifier: NLP- 990
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (6)

• Transepidermal Water Loss (TEWL)

  Baseline and Day 28

• Skin Hydration

  Measured by MoistureMeterSC

  Baseline and Day 28

• Skin Surface pH

  Baseline and Day 28

• Protein Biomarkers

  Collected by CuDerm Adhesive Tape Stripping

  Baseline and Day 28

• Skin Microbiome

  Collected by swabs

  Baseline and Day 28

• Sensitive Scale-10 Questionnaire

  Baseline and Day 28

Study Arms (2)

Occlusive comparator control

PLACEBO COMPARATOR

White Petrolatum, USP

Other: White petrolatum

Investigational moisturizer

EXPERIMENTAL

Marketed Moisturizer

Other: Investigational moisturizer

Interventions

White petrolatum OTHER

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

Occlusive comparator control

Investigational moisturizer OTHER

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

Investigational moisturizer

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Good Molecules, LLC: lead
• Sequential: collaborator

Study Sites (1)

Sequential Skin

New York, New York, 10001, United States

RECRUITING

MeSH Terms

Interventions

Petrolatum

Intervention Hierarchy (Ancestors)

Hydrocarbons; Organic Chemicals

Central Study Contacts

Dashi, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2026
• First Posted: September 10, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): December 16, 2026
• Study Completion (Estimated): January 12, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)