Skin Rejuvenation
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTprocyanidin C1
Proprietarily extracted procyanidin C1
DIETARY_SUPPLEMENTPlacebo
Placebo
DIETARY_SUPPLEMENTPCC1 complex
5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.
Sponsors
Express Rx, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 45-65 * any skin type according to the Glogau scale * No significant underlying health conditions affecting skin. * Willingness to comply with the study protocol. * Capacity to personally give informed consent (consent via legally authorized representative will not be accepted) and who are willing to comply with all study-related procedures and assessments;
Exclusion criteria
* Presence of any dermatological conditions or use of retinoids or similar compounds within 6 months of the study. * patients with active skin diseases (e.g. atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis) * patients using other anti-aging treatments within 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin Barrier Function | at baseline, week 6, and week 12. | Measured via Trans-Epidermal Water Loss (TEWL) using a VapoMeter at baseline, week 6, and week 12. |
| Wrinkle Reduction | at baseline, week 6, and week 12. | Quantified using Antera 3D imaging analysis for wrinkle indentation. |
| Skin Texture and Radiance | at baseline, week 6, and week 12. | Evaluated via VISIA-CR imaging and expert clinical grading |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Perceived Skin Improvements | 12 weeks | 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. |
| Safety and Tolerability | 12 weeks | Monitored through adverse event reports, particularly any irritation or dermatological reactions |
Countries
Switzerland
Outcome results
None listed