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

Biocoz Global Pte. Ltd.

Status: Not yet enrolling

Conditions: Skin Hydration; Healthy Skin

Treatments: Other: Corneometer® Measurement; Other: Tewameter® Measurement; Procedure: Skin biopsy

Study type: Interventional

Funder types: Industry

Identifiers

NCT07236736

1401971

Details and patient eligibility

About

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.

Full description

SPM™ is a multi-component peptide formulation designed to support skin health and barrier function. Preclinical data demonstrate reduced expression of inflammatory cytokines and potential improvements in epidermal physiology. Prior clinical data in eczematous skin suggest reductions in inflammation and improvements in clinician-assessed skin ratings. This pilot study extends investigation into healthy adults to characterize cosmetic and structural skin attributes associated with SPM™ use.

Participants aged 20-75 years will undergo screening, informed consent, and baseline assessments. Study procedures include Corneometer® hydration measurements, Tewameter® TEWL assessments, clinical photography, and 3-6 mm punch biopsies from both the application and comparison sites at baseline and end-of-treatment. Participants will apply SPM™ twice daily for 42 days. Follow-up phone calls occur after each biopsy to assess healing. A final safety follow-up visit occurs at Day 49 (±7 days) to evaluate recovery and participant-reported outcomes.

Biopsy samples will be analyzed at Mayo Clinic Pathology Core Laboratories to assess filaggrin expression and general histologic features. Additional exploratory biomarkers may be assessed in future IRB-approved studies using stored tissue.

Safety monitoring includes documentation of adverse events, with predefined stopping rules related to local tolerability, unexpected histologic findings, or systemic events. All study activities comply with ethical and regulatory standards, including 45 CFR 46, GCP, HIPAA, and WCG IRB oversight.

Enrollment: 10 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

SPM™ Application Area

Experimental group

Description:

Participants will apply the SPM™ topical cosmetic formulation twice daily for six (6) weeks to a designated skin area (e.g., right arm). SPM™ is a peptide-based cosmetic formulation containing amino acids, vitamins, and recombinant human serum albumin, designed to support healthy skin appearance, hydration, and barrier function. A matching contralateral site (e.g., left arm) will remain untreated and serve as the within-subject control for comparison. No product will be applied to this area. Skin biopsies (3-6 mm) will be obtained from both the treated and untreated sites at two timepoints: Baseline (before starting SPM™ application), and End of the 6-week product-use period. Biopsy samples from both sites will be analyzed in parallel to characterize cosmetic skin attributes (e.g., structure, hydration-related markers, and barrier-related characteristics) and to compare changes between the SPM™-treated and untreated control areas.

Treatment:

Procedure: Skin biopsy

Other: Tewameter® Measurement

Other: Corneometer® Measurement