SPM™ for Healthy Skin

(SPMT Trial)

Overseen By Guillermo Barahona

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: BizCoz Global PTE. LTD

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Skin cancer, Eczema, Psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a new skin product, SPM™, can improve skin appearance, enhance hydration, and protect the skin's barrier. Participants will apply the product to one area of their skin for six weeks, while another area remains untreated for comparison. Researchers will assess changes by measuring the skin's moisture levels and structure before and after product use. This trial suits healthy adults without ongoing skin issues who consent to small skin samples being taken. As an unphased trial, it offers participants the chance to contribute to foundational research that could lead to innovative skincare solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using systemic corticosteroids or immunosuppressants.

What prior data suggests that SPM™ is safe for cosmetic use?

Research has shown that SPM™, a cream made with peptides, is designed to be safe for cosmetic use. This treatment includes ingredients like amino acids, vitamins, and recombinant human serum albumin, which are commonly found in skincare products and are known to be well-tolerated.

Although detailed safety studies specifically on SPM™ are lacking, its ingredients are generally considered safe for skin application. In cosmetics, safety checks often avoid animal testing and use alternative methods to ensure products do not irritate the skin or cause other issues.

This study is exploratory and focuses on cosmetic use, so the treatment is not expected to cause significant side effects. Participants will apply the product only to their skin, reducing the risk of serious adverse effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

SPM™ is unique because it combines peptides, amino acids, vitamins, and recombinant human serum albumin to enhance skin health, hydration, and barrier function. Unlike most standard skincare treatments, which often focus on moisturizing or exfoliating, SPM™ aims to improve skin structure and function at a molecular level. Researchers are excited about this treatment because it leverages a new peptide-based formulation that could offer more comprehensive skin benefits than conventional topical products.

What evidence suggests that SPM™ is effective for improving skin appearance and hydration?

Research has shown that SPM™, a cream made with special proteins, might improve skin health by reducing irritation and boosting skin function. Early laboratory studies found that SPM™ can decrease certain proteins that cause skin irritation. The cream is also designed to increase skin moisture and strengthen the skin's protective layer, promoting skin health. In this trial, participants will apply SPM™ to one designated skin area, while another area will remain untreated as a control. Although human trial data is limited, these early results suggest that SPM™ could enhance skin health and hydration. ^{1 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in improving their skin's appearance, hydration, and barrier function. Participants should be willing to apply a topical peptide-based formulation twice daily and undergo noninvasive skin measurements as well as small punch biopsies.

Inclusion Criteria

Able to provide written informed consent

I am willing to have skin biopsies and follow the study's procedures.

I am generally healthy and do not have any skin or systemic diseases.

Exclusion Criteria

I am currently taking steroids or immunosuppressants.

Known allergy or sensitivity to components of the investigational product

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants apply SPM™ topical cosmetic formulation twice daily for six weeks to a designated skin area

6 weeks

2 visits (in-person) for biopsies

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a final safety follow-up visit to evaluate recovery and participant-reported outcomes

1 week

1 visit (in-person), follow-up phone calls

What Are the Treatments Tested in This Trial?

Interventions

• SPM™

Trial Overview The study tests the effects of SPM™, a new skincare product, on healthy adult skin over six weeks. It measures how well it hydrates the skin and strengthens its barrier by comparing treated areas with untreated ones using tools like Tewameter® and Corneometer®.

How Is the Trial Designed?

Group I: SPM™ Application Area Experimental Treatment 3 Interventions

Participants will apply the SPM™ topical cosmetic formulation twice daily for six (6) weeks to one designated skin area (e.g., right arm). SPM™ is a peptide-based, multi-component formulation containing amino acids, vitamins, and recombinant human serum albumin, designed to support healthy skin appearance, hydration, and barrier function. 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)

Group II: Untreated Control Area Active Control 3 Interventions

The contralateral matched skin site (e.g., left arm) will remain untreated and serve as the within-subject control for comparison with the SPM™-treated site. No topical product will be applied to this area. Skin biopsies (3-6 mm) will be performed at the same two time points as in the treated arm: Baseline (prior to product initiation on the treated site) End of product-use period (after 6 weeks) Biopsy samples from the untreated control site will be analyzed in parallel to assess differences in skin structure, hydration, and barrier-related markers relative to the SPM™-treated site.

Who Is Running the Clinical Trial?

BizCoz Global PTE. LTD

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07236736

Evaluation of SPM™ Topical Cosmetic Application on Skin ... Preclinical data demonstrate reduced expression of inflammatory cytokines and potential improvements in epidermal physiology.

2. trial.medpath.com trial.medpath.com/clinical-trial/b57bd151c0126028/nct07236736-spm-topical-cosmetic-skin-hydration-barrier

Evaluation of SPM™ Topical Cosmetic Application on Skin ... Preclinical data demonstrate reduced expression of inflammatory cytokines and potential improvements in epidermal physiology.

3. medicaldevicenavigator.com medicaldevicenavigator.com/upcoming_clinical_study_evaluates_spm_cosmetic_application/

Upcoming Clinical Study Evaluates SPM™ Cosmetic ... The trial's main goals include quantifying the impact of SPM™ on skin hydration levels and overall barrier integrity. These parameters are critical in assessing ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12554163/

Fibroblast exosomes promote wound healing and improve the ... Our findings demonstrate that fibroblast exosome treatment not only accelerates wound closure but also improves the long-term quality of healed ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666154325000225

Biochemical insights into specialized plant metabolites Clinical studies have demonstrated the efficacy of flavonoids in improving skin barrier function and reducing irritation. For instance, quercetin, a ...

6. researchgate.net researchgate.net/publication/49638924_Safety_of_botanical_ingredients_in_personal_care_productscosmetics

Safety of botanical ingredients in personal care products/ ... When choosing new ingredients for cosmetic formulations, data on cyto-and genotoxicity, skin irritation, photosensitization, dermal ...

7. seppic.com seppic.com/article/master-the-microplastic-regulation-in-cosmetics

3 questions to master the microplastic regulation in cosmetics Cosmetic manufacturers have to be vigilant about compliance. In this article, let's understand the regulation on microplastics and microbeads use, explore the ...

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34459931/

Safety assessment of cosmetics by read across applied to ... As a result of the cosmetics testing ban, safety evaluations of cosmetics ingredients must now be conducted using animal-free methods.