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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-75
SponsorBiocoz Global Pte. Ltd.

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Skin biopsy

    Procedure/Surgery

    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).

  • Corneometer® Measurement

    Other intervention

    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.

  • Tewameter® Measurement

    Other intervention

    Noninvasive transepidermal water loss (TEWL) measurement using the Tewameter® device to assess barrier function before and after the 6-week product-use period.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: SPM™ Application AreaExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)

Secondary outcomes

1

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.

Time frame
Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
2

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™.

Time frame
Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
3

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.

Time frame
Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
4

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.

Time frame
Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)

Other outcomes

Sponsors and contacts

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