Study of PCC1 and Senolytic Complex (Cellumiva) for Skin Rejuvenation

Not Applicable

Completed

• Conditions: Skin Rejuvenation

• Registration Number: NCT06641869
• Lead Sponsor: Express Rx, Inc

Brief Summary

This clinical trial will assess the efficacy of PCC1 and the Senolytic Complex Cellumiva 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 and Cellumiva, 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 and the senolytic complex Cellumiva in skin rejuvenation over 12 weeks. Healthy female participants aged 45-65 will be randomly assigned to receive PCC1, Cellumiva (a blend including procyanidin C1, Pterostilbene, and Spermidine), 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.

Study Timeline

• Study Start: 2022-10-10
• Primary Completion: 2024-02-23
• Study Completion: 2024-08-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-12
• Study First Posted: 2024-10-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Wrinkle Reduction	at baseline, week 6, and week 12.	Quantified using Antera 3D imaging analysis for wrinkle indentation.
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.
Skin Texture and Radiance	at baseline, week 6, and week 12.	Evaluated via VISIA-CR imaging and expert clinical grading

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Geneva; 🇨🇭 Geneva, Switzerland