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This clinical trial will assess the efficacy of PCC1 for skin rejuvenation. The primary objective is to determine whether these interventions enhance skin barrier function, reduce wrinkles, and improve skin texture and radiance over a 12-week period. The study will involve healthy participants applying the treatments and undergoing assessments at baseline, 6 weeks, and 12 weeks. Secondary objectives include evaluating the safety and tolerability of PCC1, with any adverse effects closely monitored during the trial.
As skin ages, intrinsic and extrinsic factors contribute to cellular senescence, disrupting the skin's structure and function. Senescent cells accumulate in the skin, leading to the secretion of senescence-associated secretory phenotype (SASP) factors, which promote inflammation and degrade extracellular matrix proteins like collagen. These changes result in wrinkles, loss of elasticity, and reduced skin barrier function. The study explores anti-senescence strategies using senolytic agents that selectively eliminate senescent cells, aiming to rejuvenate the skin. Compounds like PCC1 and Cellumiva have shown promise in targeting senescent cells by inducing apoptosis and reducing SASP expression, offering a novel approach to skin aging therapy.
This clinical trial is designed to evaluate the efficacy and safety of PCC1 in skin rejuvenation over 12 weeks. Healthy female participants aged 45-65 will be randomly assigned to receive PCC1 or a placebo. The study will measure skin barrier function, wrinkle reduction, and texture/radiance improvements using imaging technologies and participant feedback. Safety will also be monitored through adverse event reporting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCC1 Group | Experimental | Dosage Form: Oral dietary supplement. Dosage: 2.5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks. |
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| Placebo | Placebo Comparator | Dosage Form: Oral placebo supplement. Dosage: Administered once daily. Duration: 12 weeks. |
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| PCC1 Complex | Experimental | Dosage: 5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| procyanidin C1 | Dietary Supplement | Proprietarily extracted procyanidin C1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Barrier Function | Measured via Trans-Epidermal Water Loss (TEWL) using a VapoMeter at baseline, week 6, and week 12. | at baseline, week 6, and week 12. |
| Wrinkle Reduction | Quantified using Antera 3D imaging analysis for wrinkle indentation. | at baseline, week 6, and week 12. |
| Skin Texture and Radiance | Evaluated via VISIA-CR imaging and expert clinical grading | at baseline, week 6, and week 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Perceived Skin Improvements | This outcome will be assessed using the Self-Perceived Skin Improvement Scale (SPSIS), a questionnaire with a minimum score of 0 and a maximum of 100. Higher scores indicate better self-perceived skin improvements. Participants will evaluate hydration, smoothness, radiance, and overall appearance of their skin. Results will be measured at baseline and at the end of 12 weeks. Separate outcome measures will be reported for each parameter (hydration, smoothness, radiance), based on individual scores from the SPSIS. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emilia Loewe | Express Rx, Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Geneva | Geneva | Switzerland |
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| ID | Term |
|---|---|
| C000630864 | procyanidin trimer C1 |
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| Placebo |
| Dietary Supplement |
Placebo |
|
| PCC1 complex | Dietary Supplement | 5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks. |
|
| 12 weeks |
| Safety and Tolerability | Monitored through adverse event reports, particularly any irritation or dermatological reactions | 12 weeks |