Study to Assess the Efficacy of EMC-CAP-2025A on Age-Related Skin Parameters in Healthy Individuals

Phase 2Active Not RecruitingNCT07493850

Circul'Egg60 enrolled

Overview

The goal of this clinical study is to evaluate the efficacy and tolerability of EMC-CAP-2025A, an eggshell membrane-based dietary supplement, on age-related skin parameters in healthy adults. The main questions this study aims to answer are: * Does daily supplementation with EMC-CAP-2025A improve facial wrinkles compared to placebo? * Does EMC-CAP-2025A improve skin hydration, firmness, elasticity, texture, and overall skin quality? * Is EMC-CAP-2025A well tolerated when taken daily for 60 days? Researchers will compare EMC-CAP-2025A to a placebo to assess its effects on multiple skin parameters using objective instrumental assessments and participant self-evaluations. Participants will: * Be randomly assigned to receive either EMC-CAP-2025A or a placebo * Take one capsule orally once daily for 60 days * Attend scheduled study visits at baseline, Day 30, and Day 60 for instrumental skin assessments and safety evaluations * Complete self-assessment questionnaires related to skin quality and product tolerability

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Enrollment

Conditions

Facial Wrinkles Skin Hydration Skin Elasticity

Eligibility

Sex: ALLMin age: 30 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Individuals who are willing to understand and sign a written informed consent form prior to the study. 2. Healthy male and female individuals aged between 30 to 55 years (both values included). 3. Individuals showing symptoms of aging, with mild to moderate wrinkles in crow's feet area based on PI discretion. 4. Individuals with any one of the following skin conditions along with mild to moderate wrinkles: 1. Under-eye dark circles 2. Hyperpigmentation spots (blemish) (post-inflammatory hyperpigmentation, acne marks, age spots, sunspots) 3. Dry dull skin 5. Individuals willing to maintain stable dietary patterns and maintain adequate hydration every day throughout the study 6. Individuals who are willing to attend all scheduled study visits at the test center and agree to refrain from applying any topical products (e.g.,moisturizers, creams, or similar treatments) 24 hours prior to each visit. 7. Willingness to participate in the study and comply with the study procedures and required visits. Exclusion Criteria: 1. Individuals having an allergy to any of the components of the IP. 2. Use of another investigational product within 90 days prior to the screening visit. 3. Individuals with any dermatologic disorders or skin conditions that could interfere with the evaluation of proprietary supplement's effects. 4. Individuals having an underlying disease or surgical or medical condition that could put them at risk in the opinion of Principal Investigator, including anyuncontrolled chronic or serious disease that would prevent participation in the study, such as cancer, AIDS, diabetes, obesity, renal impairment, psychiatricdisorder, compromised immunity, etc. 5. Individuals having a history of self-reported allergies to cosmetic and/or sunscreen products. 6. Individuals who have used or are unwilling to abstain from using any topical or systemic skin-treatment products or dietary supplements with claims toimprove skin hydration, firmness, anti-aging, anti-wrinkle, skin lightening, or dyschromia correction - including those containing alpha/beta/poly-hydroxyacids, salicylic acid, vitamin C, collagen, hyaluronic acid, soy, CoQ-10, chondroitin sulfate, hydroquinone, corticosteroids, tretinoin, retinoids, or anycombination thereof - within 1 month prior to screening or during the study period. 7. Individuals currently using oral or topical health foods, supplements, pharmaceuticals, or cosmetics that claim whitening or skin-texture improvementeffects such as but not limited to glutathione, cysteine, placenta-based extracts, Vitamins C/E/A (retinol), astaxanthin, lycopene, etc., and who cannotrefrain from using them during the study period. 8. Individuals who have undergone any facial cosmetic or aesthetic procedures, including beauty injections, deep or superficial-to-mid chemical peels,dermabrasion, laser resurfacing, Thermage, tanning, cosmetic surgery, or any equivalent high-energy or anti-aging facial treatments, within 3 months priorto the screening visit. 9. Individuals who had hormone replacement therapy within 3 months preceding the screening visit. 10. Individuals who have used oral contraceptives or had changed contraceptive method within 3 months prior to the screening visit, or plan to modifycontraception treatment within the duration of study. 11. Employees of the clinical labs or other testing firms or laboratories, as well as those of cosmetic or raw-material manufacturers of topical products ortheir suppliers. 12. Individuals who are undergoing medical treatment or have a medical history of lupus, scleroderma, atopic dermatitis, acne, facial scarring, psoriasis,eczema, and other autoimmune/inflammatory scaly skin disorders. 13. History of uncontrolled hypertension with systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure more than or equalto 90 mmHg. 14. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. 15. History of smoking or currently smoking and also using any form of smokeless tobacco. 16. Individuals having a history of or ongoing drug or alcohol abuse.

Outcomes

Primary Outcomes

To assess the effect of Investigational product at Day 60 in comparison to baseline and placebo on Wrinkles in the nasolabial and lateral canthal region near the eyes (crow's feet)

Wrinkles \[average wrinkle length, average wrinkle area, average wrinkle volume, average wrinkle count\] measurement using 3D imaging. Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)

Time frame: Day 0 to Day 60

Secondary Outcomes

Skin hydration at Day 30 and Day 60 in comparison to baseline and placebo as assessed by the Moisture Meter SC.

The MoistureMeter SC measures the hydration of the skin surface, the stratum corneum. The skin is an electrically layered structure. The electrical properties of its layers are related to their water content. The probe, the skin surface and the deeper skin layers form a structure, like an electrical capacitor. The measured capacitance is proportional to the water content of the surface layer of the skin. The higher the reading, the higher the moisture content. Instrument: MoistureMeter SC Compact (Delfin Technologies, Kuopio, Finland)