Healthy SkinSPMTNCT07236736
Evaluation of SPM™ Topical Cosmetic Application on Skin Appearance, Hydration, and Barrier Support in Healthy Adults
A study testing Skin biopsy, Corneometer® Measurement and Tewameter® Measurement in people with Healthy Skin and Skin Hydration, run by Biocoz Global Pte. Ltd. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Skin, Skin Hydration
- What is being tested?
- Skin biopsy, Corneometer® Measurement and Tewameter® Measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2027to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Project Quality of Life
West Hollywood, California, 90069
Daniel Rahmann, 310-907-8348, daniel@drchristiela.com
Christie Prendergast, DO
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy Skin, Skin Hydration
- Being tested
- Skin biopsy, Corneometer® Measurement, Tewameter® Measurement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin biopsyProcedure or 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® MeasurementOther
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® MeasurementOther
Noninvasive transepidermal water loss (TEWL) measurement using the Tewameter® device to assess barrier function before and after the 6-week product-use period.
| Study group | Role | What they receive |
|---|---|---|
| SPM™ Application Area | Experimental | Participants will apply the SPM™ topical cosmetic formulation twice daily for six (6) weeks to a designated skin area (e.g., right arm). SPM™ is a peptide-based cosmetic formulation containing amino acids, vitamins, and recombinant human serum albumin, designed to support healthy skin appearance, hydration, and barrier function.
A matching contralateral site (e.g., left arm) will remain untreated and serve as the within-subject control for comparison. No product will be applied to this area.
Skin biopsies (3-6 mm) will be obtained from both the treated and untreated sites at two timepoints:
Baseline (before starting SPM™ application), and
End of the 6-week product-use period.
Biopsy samples from both sites will be analyzed in parallel to characterize cosmetic skin attributes (e.g., structure, hydration-related markers, and barrier-related characteristics) and to compare changes between the SPM™-treated and untreated control areas. Receives: Procedure: Skin biopsy; Other: Corneometer® Measurement; Other: Tewameter® Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
Secondary outcomes (5)
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.
Measured: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
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™.
Measured: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
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.
Measured: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
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.
Measured: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9).
Participants will complete a self-reported questionnaire assessing perceived changes in skin comfort, hydration, smoothness, and overall cosmetic benefit after SPM™ use. Scores for each domain range from 0 to 100, with higher scores indicating greater satisfaction.
Measured: End of study (Day 42-49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start30 Jan 2027 (estimated)
- Primary completion5 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biocoz Global Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236736
- Sponsor's protocol ID
- 1401971
- Acronym
- SPMT
- Status last verified
- Oct 2026
- First submitted
- 15 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of SPM™ Topical Cosmetic Application on Skin Appearance, Hydration, and Barrier Support in Healthy Adults
- ClinicalTrials.gov ID
- NCT07236736
- Acronym / sponsor ID
- SPMT / 1401971
- Conditions
- Healthy Skin, Skin Hydration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Biocoz Global Pte. Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 5 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPM™ Application Area | Experimental | Procedure: Skin biopsy, Other: Corneometer® Measurement, Other: Tewameter® MeasurementParticipants will apply the SPM™ topical cosmetic formulation twice daily for six (6) weeks to a designated skin area (e.g., right arm). SPM™ is a peptide-based cosmetic formulation containing amino acids, vitamins, and recombinant human serum albumin, designed to support healthy skin appearance, hydration, and barrier function. A matching contralateral site (e.g., left arm) will remain untreated and serve as the within-subject control for comparison. No product will be applied to this area. Skin biopsies (3-6 mm) will be obtained from both the treated and untreated sites at two timepoints: Baseline (before starting SPM™ application), and End of the 6-week product-use period. Biopsy samples from both sites will be analyzed in parallel to characterize cosmetic skin attributes (e.g., structure, hydration-related markers, and barrier-related characteristics) and to compare changes between the SPM™-treated and untreated control areas. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin biopsySkin 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). | Procedure or surgery | SPM™ Application Area |
| Corneometer® MeasurementNoninvasive 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. | Other | SPM™ Application Area |
| Tewameter® MeasurementNoninvasive transepidermal water loss (TEWL) measurement using the Tewameter® device to assess barrier function before and after the 6-week product-use period. | Other | SPM™ Application Area |
Primary outcome
Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application
Time frame: 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.
5 secondary outcomes
Change in Skin Hydration
Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
Change in Transepidermal Water Loss (TEWL)
Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
Change in Skin Appearance (Photographic Assessment)
Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
Safety and Tolerability (Adverse Events and Local Reactions)
Time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)
Treatment Satisfaction Questionnaire for Medication 9 (TSQM-9).
Time frame: End of study (Day 42-49)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skin biopsy, Corneometer® Measurement and Tewameter® Measurement in people with Healthy Skin and Skin Hydration, run by Biocoz Global Pte. Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillermo Barahona (4106038343, guillermobarah@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin structure and protein expression (filaggrin levels) after 6 weeks of SPM™ topical application (time frame: Baseline (Day 0) and Week 6 - End of Product Use (Day 42 ± 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.