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

Express Rx, Inc

Status: Completed

Conditions: Skin Rejuvenation

Treatments: Dietary Supplement: procyanidin C1; Dietary Supplement: Cellumiva; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06641869

EXRX023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 3 patient groups, including a placebo group

PCC1 Group

Experimental group

Description:

Dosage Form: Oral dietary supplement. Dosage: 2.5 mg of procyanidin C1. Frequency: Administered once daily. Duration: 12 weeks.

Treatment:

Dietary Supplement: procyanidin C1

Cellumiva Group

Experimental group

Description:

Dosage Form: Oral dietary supplement. Dosage: Blend containing Procyanidin C1, Pterostilbene, and Spermidine. Frequency: Administered once daily. Duration: 12 weeks.

Treatment:

Dietary Supplement: Cellumiva

Placebo

Placebo Comparator group

Description:

Dosage Form: Oral placebo supplement. Dosage: Administered once daily. Duration: 12 weeks.

Treatment:

Dietary Supplement: Placebo