Study of PCC1 for Skin Rejuvenation

A 12-week , Randomized, Open-label Study of PCC1 in Healthy Volunteers for Skin Rejuvenation

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.

Study Overview

• Status: Completed
• Conditions: Skin Rejuvenation
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: procyanidin C1; Dietary supplement: PCC1 complex

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • University of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Dosage Form: Oral placebo supplement. Dosage: Administered once daily. Duration: 12 weeks.	Dietary supplement: Placebo; Placebo
Experimental: PCC1 Group; Dosage Form: Oral dietary supplement. Dosage: 2.5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.	Dietary supplement: procyanidin C1; Proprietarily extracted procyanidin C1
Experimental: PCC1 Complex; Dosage: 5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.	Dietary supplement: PCC1 complex; 5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.	12 weeks
Safety and Tolerability	Monitored through adverse event reports, particularly any irritation or dermatological reactions	12 weeks

Collaborators and Investigators

• Sponsor: Express Rx, Inc
• Investigators: Principal Investigator: Emilia Loewe, Express Rx, Inc

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Actual): February 23, 2024
• Study Completion (Actual): August 10, 2024

Study Registration Dates

• First Submitted: October 10, 2024
• First Submitted That Met QC Criteria: October 12, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 6, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antiprotozoal Agents; Antiparasitic Agents; Antioxidants; Protective Agents; Proanthocyanidin; Procyanidin
• Other Study ID Numbers: EXRX023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No