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Clinical Trials in the USA / NCT07236736
Starting soon Not applicable

Evaluation of SPM™ Topical Cosmetic Application on Skin Appearance, Hydration, and Barrier Support in Healthy Adults

NCT07236736 · tracked via the Priya Life Science USA tracker
Sponsor
Biocoz Global Pte. Ltd
Phase
Not applicable
Started
2027-01-30
Last updated
2026-10-06

Condition(s) studied

Healthy SkinSkin Hydration

Investigational drug(s) / intervention(s)

Skin biopsyCorneometer® MeasurementTewameter® Measurement

Skin biopsy: Skin biopsies (3-6 mm) will be performed at two time points: Baseline (prior to initiation of SPM™ application) End of product-use period (after 6 weeks of twice-daily application) These samples will be analyzed for cosmetic-related skin structure and protein expression characteristics (e.g., filaggrin levels and barrier markers).

Corneometer® Measurement: Noninvasive skin hydration assessment using the Corneometer® instrument at baseline and after 6 weeks. The device quantifies the moisture content of the stratum corneum through dielectric constant measurement.

Tewameter® Measurement: Noninvasive transepidermal water loss (TEWL) measurement using the Tewameter® device to assess barrier function before and after the 6-week product-use period.

Study summary

This is an exploratory, cosmetic-use study evaluating the effects of Super Protein Multifunction (SPM™), a topical peptide-based formulation, on skin appearance, hydration, and barrier-related characteristics in healthy adults. The study aims to collect preliminary biophysical and histologic data on cosmetic skin changes following six weeks of SPM™ use. Participants will apply the product to a designated skin area while a matched contralateral area serves as the untreated comparison site. Skin hydration, transepidermal water loss (TEWL), and tissue markers of skin structure and barrier integrity will be assessed before and after product use. The study includes noninvasive measurements and small punch biopsies at two timepoints.

Eligibility

Sex
ALL
Min age
20 Years
Max age
75 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Generally healthy with no systemic or active dermatologic diseases. 2. Willing and able to apply topical product daily for 6 weeks. 3. Able to provide written informed consent. 4. Willing to undergo skin biopsies and follow study procedures. Exclusion Criteria: 1. History of skin cancer or other malignancy within the past 10 years. 2. Active or chronic dermatologic conditions (e.g., eczema, psoriasis, acne, rosacea). 3. Known allergy or sensitivity to components of the investigational product. 4. Current use of systemic corticosteroids or immunosuppressants. 5. Pregnancy or breastfeeding. 6. Any condition that, in the investigator's opinion, would interfere with study participation or pose additional risk.

Primary outcome measure(s)

  • Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application — Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
    To evaluate histologic and protein expression changes in skin tissue following six weeks of twice-daily SPM™ topical application, compared to baseline and to the untreated control area. Paired punch biopsies (3-6 mm) will be collected at baseline and after completion of product use. Filaggrin expression and general tissue features (e.g., epidermal thickness, keratinocyte morphology, and barrier integrity) will be assessed via immunohistochemistry and histologic analysis.

Trial sites (1)

FacilityCityRegionStatus
Project Quality of Life West Hollywood California

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07236736 on ClinicalTrials.gov ↗ ← All trials in the USA