Study of PCC1 for Skin Rejuvenation

August 6, 2025 updated by: Express Rx, Inc

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Skin Barrier Function
Time Frame: at baseline, week 6, and week 12.
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
Time Frame: at baseline, week 6, and week 12.
Quantified using Antera 3D imaging analysis for wrinkle indentation.
at baseline, week 6, and week 12.
Skin Texture and Radiance
Time Frame: at baseline, week 6, and week 12.
Evaluated via VISIA-CR imaging and expert clinical grading
at baseline, week 6, and week 12.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Perceived Skin Improvements
Time Frame: 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.
12 weeks
Safety and Tolerability
Time Frame: 12 weeks
Monitored through adverse event reports, particularly any irritation or dermatological reactions
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Express Rx, Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emilia Loewe, Express Rx, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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