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

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.

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.