Evaluation of SPM™ Topical Cosmetic Application on Skin Appearance, Hydration, and Barrier Support in Healthy Adults
NCT ID: NCT07236736
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
10 participants
INTERVENTIONAL
2026-01-30
2027-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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SPM™ Application Area
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
75 Years
ALL
Yes
Sponsors
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Biocoz Global Pte. Ltd.
INDUSTRY
Responsible Party
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Locations
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Project Quality of Life
West Hollywood, California, United States
Countries
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Central Contacts
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Facility Contacts
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Daniel Rahmann
Role: primary
Other Identifiers
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1401971
Identifier Type: -
Identifier Source: org_study_id