Evaluation of SPM™ Topical Cosmetic Application on Skin Appearance, Hydration, and Barrier Support in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application
时间窗: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
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.
次要结局
- 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))
- 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))