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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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).
• Другое 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.
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

США · 1 центр

• Project Quality of Life — West Hollywood

Идентификаторы

NCT: NCT07236736 · 1401971

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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