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

NCT07236736 | Not Yet Recruiting

• 1 other identifier: 1401971
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Hydration; Healthy Skin

Outcome Measures

Primary Outcomes (1)

• Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application

  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.

  Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)

Secondary Outcomes (5)

• Change in Skin Hydration

  Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)

• Change in Transepidermal Water Loss (TEWL)

  Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)

• Change in Skin Appearance (Photographic Assessment)

  Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)

• Safety and Tolerability (Adverse Events and Local Reactions)

  Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)

• Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9).

  End of study (Day 42-49)

Study Arms (1)

SPM™ Application Area

EXPERIMENTAL

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.

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

Interventions

Skin biopsy PROCEDURE

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).

SPM™ Application Area

Corneometer® Measurement OTHER

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.

SPM™ Application Area

Tewameter® Measurement OTHER

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

SPM™ Application Area

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Generally healthy with no systemic or active dermatologic diseases.
• Willing and able to apply topical product daily for 6 weeks.
• Able to provide written informed consent.
• Willing to undergo skin biopsies and follow study procedures.

You may not qualify if:

• History of skin cancer or other malignancy within the past 10 years.
• Active or chronic dermatologic conditions (e.g., eczema, psoriasis, acne, rosacea).
• Known allergy or sensitivity to components of the investigational product.
• Current use of systemic corticosteroids or immunosuppressants.
• Pregnancy or breastfeeding.
• Any condition that, in the investigator's opinion, would interfere with study participation or pose additional risk.

Sponsors & Collaborators

• Biocoz Global Pte. Ltd.: lead

Study Sites (1)

Project Quality of Life

West Hollywood, California, 90069, United States

Location

Central Study Contacts

Guillermo Barahona

CONTACT

4106038343; guillermobarah@icloud.com

Daniel Rahmann

CONTACT

3107707917; daniel@drchristiela.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2025
• First Posted: November 19, 2025
• Study Start: January 30, 2026
• Primary Completion (Estimated): December 5, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: December 19, 2025

Record last verified: 2025-11

Locations

US (1)