Clinical trial NCT06641869: Study of PCC1 and Senolytic Complex (Cellumiva) for Skin Rejuvenation
Official title: A 12-week , Randomized, Open-label Study of PCC1 and Senolytic Complex (Cellumiva) in Healthy Volunteers for Skin Rejuvenation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Rejuvenation
Lead sponsor: Express Rx, Inc
Sponsor class: INDUSTRY
First posted: 2024-10-15
Enrollment: 74
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Skin Barrier Function
timeFrame: at baseline, week 6, and week 12.
measure: Wrinkle Reduction
timeFrame: at baseline, week 6, and week 12.
measure: Skin Texture and Radiance
timeFrame: at baseline, week 6, and week 12.
Secondary outcomes:
measure: Self-Perceived Skin Improvements
timeFrame: 12 weeks
measure: Safety and Tolerability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University of Geneva
Study officials:
affiliation: Express Rx, Inc
name: Emilia Loewe
role: PRINCIPAL_INVESTIGATOR
References: