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

Overview

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.

Detailed 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.

Interventions

• Procedure 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).
• Other 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.
• Other 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.

Primary outcome measures

• Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application [Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)]

Secondary outcome measures (5)

• Change in Skin Hydration [Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)]
• Change in Transepidermal Water Loss (TEWL) [Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)]
• Change in Skin Appearance (Photographic Assessment) [Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)]
• Safety and Tolerability (Adverse Events and Local Reactions) [Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)]
• Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9). [Time frame: End of study (Day 42-49)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

United States · 1 center

• Project Quality of Life — West Hollywood

Identifiers

NCT: NCT07236736 · 1401971

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗