None listed
Conditions
Interventions
Intervention1: EMC-CAP-2025A: EMC-CAP-2025A 300 mg per capsule
Regimen: 1 capsule per day after meals Route: Oral
Duration: 60 days
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Circul Egg
Eligibility
Inclusion criteria
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: a. Under-eye dark circles b.Hyperpigmentation spots (blemish) (post-inflammatory hyperpigmentation, acne marks, age spots, sunspots) c. 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
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 any uncontrolled chronic or serious disease that would prevent participation in the study, such as cancer, AIDS, diabetes, obesity, renal impairment, psychiatric disorder, 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 to improve skin hydration, firmness, anti-aging, anti-wrinkle, skin lightening, or dyschromia correction including those containing alpha/beta/poly-hydroxy acids, salicylic acid, vitamin C, collagen, hyaluronic acid, soy, CoQ-10, chondroitin sulfate, hydroquinone, corticosteroids, tretinoin, retinoids, or any combination 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 improvement effects such as but not limited to glutathione, cysteine, placenta-based extracts, Vitamins C/E/A (retinol), astaxanthin, lycopene, etc., and who cannot refrain 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 prior to 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 modify contraception 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 or their 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 equal to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of Investigational product at Day 60 in comparison to baselineTimepoint: Day 0 to Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the effect of Investigational product at Day 30 in comparison to baseline and placebo on Wrinkles in the nasolabial and lateral canthal region near the eyes as assessed by 3D imaging.Timepoint: Day 0 to Day 60;Skin hydration at Day 30 and Day 60 in comparison to baseline and placebo as assessed by the Moisture Meter SC.Timepoint: Day 0, Day 30 and Day 60;Skin firmness and elasticity at Day 30 and Day 60 in comparison to baseline and placebo as assessed by Cutometer.Timepoint: Day 0, Day 30 and Day 60;Hyperpigmentation spots (blemishes, post-inflammatory hyperpigmentation, acne marks, age spots, sunspots), average pore volume, porosity index, and roughness at Day 30 and Day 60 in comparison to baseline and placebo as assessed by 3D imaging.Timepoint: Day 0, Day 30 and Day 60;Skin texture and roughness at Day 30 and Day 60 in comparison to baseline and placebo as assessed by the Allergan skin roughness scaleTimepoint: Day 0, Day 30 and Day 60;Skin quality like lines and wrinkles, crow s feet, smoothness, skin hydration, moisture, skin tone, skin radiance, skin discomfort such as itching, burning, prickling, irritation, and redness and pimples on skin at Day 30 and Day 60 in comparison to baseline and placebo as assessed by participants self-assessment.Timepoint: Day 0, Day 30 and Day 60;Tolerability of the Investigational Product as assessed by self-assessment questionnaire.Timepoint: Day 60 | — |
Countries
India
Contacts
Public ContactDr Sonal Raote
Vedic Lifesciences Pvt Ltd
Outcome results
None listed