About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Skin biopsy
Procedure/SurgerySkin 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
Other interventionNoninvasive 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
Other interventionNoninvasive transepidermal water loss (TEWL) measurement using the Tewameter® device to assess barrier function before and after the 6-week product-use period.
Treatment groups
Trial outcomes
Primary outcomes
Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application
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.
Secondary outcomes
Change in Skin Hydration
Skin hydration will be quantified using a Corneometer® device at baseline and after six weeks of product use. Measurements will be performed on both the SPM™-treated area and the contralateral untreated control area.
Change in Transepidermal Water Loss (TEWL)
Skin barrier function will be evaluated using a Tewameter® device to measure transepidermal water loss (TEWL) at baseline and after six weeks. Assessments will be performed at both treated and untreated areas to determine barrier-related effects of SPM™.
Change in Skin Appearance (Photographic Assessment)
Standardized clinical photographs will be captured under consistent lighting and positioning conditions at baseline and after six weeks to document visible changes in skin texture, tone, and smoothness. Images will be assessed for cosmetic improvements using qualitative scoring.
Safety and Tolerability (Adverse Events and Local Reactions)
Frequency and severity of product-related local skin reactions (e.g., erythema, irritation, dryness) and biopsy-related adverse events will be recorded and summarized.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: