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

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of EMC-CAP-2025A on Age-Related Skin Parameters in Healthy Individuals

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 Overview

• Status: Active, not recruiting
• Conditions: Skin Elasticity; Facial Wrinkles; Skin Hydration
• Intervention / Treatment: Dietary supplement: EMC-CAP-2025A; Dietary supplement: EMC-CAP-2025B

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • C.L.A.I.M.S. Private Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EMC-CAP-2025A	Dietary supplement: EMC-CAP-2025A; EMC-CAP-2025A 300 mg per capsule Regimen: 1 capsule per day after meals Route: Oral Duration: 60 days
Placebo Comparator: EMC-CAP-2025B	Dietary supplement: EMC-CAP-2025B; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Day 0 to Day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	The Cutometer is a measuring device that helps to estimate the degree of firmness and elasticity of the skin using negative pressure, which deforms the skin mechanically. The measuring principle is based on the suction method. Negative pressure is created in the device, and the skin is drawn into the aperture of the probe and after a defined time released again. The resistance of the skin to the negative pressure gives the skin firmness and its ability to return to its original position gives the elasticity of the skin. Cutometric measurements are carried out on the cheeks. The following parameters will be analyzed for this study. Readings will be taken at all visits.; Firmness (R0): Uf= First max. Amplitude, highest point of the first curve, has an implication for the firmness of the skin. This parameter represents the passive behavior of the skin to force.; Elasticity (R7): This gives an indication of the elasticity of the skin.	Day 0, Day 30 and Day 60
Hyperpigmentation spots (blemishes, post-inflammatory hyperpigmentation, acne marks, age spots, sunspots) at Day 30 and Day 60 in comparison to baseline and placebo as assessed by 3D imaging.	Hyperpigmentation spots (blemish, post-inflammatory hyperpigmentation, acne marks, age spots, sunspots)-[mean pigmentation, mean L*] measurement using 3D imaging. Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)	Day 0, Day 30 and Day 60
Average pore volume and porosity index at Day 30 and Day 60 in comparison to baseline and placebo as assessed by 3D imaging.	Average pore volume and porosity index measurement using 3D imaging. The Optical 3D is a camera for image acquisition and analysis of the skin. It relies on multi-directional illumination and computer-aided reconstruction of the skin surface, illuminating the surface from different angles and using the differences between these images to reconstruct the surface in three dimensions. The skin topography and the chromophores concentration are derived from the spatial and spectral analysis of the acquired image data, obtained by illuminating the skin with light emitting diodes (LEDs) of different wavelengths (455 to 625 nm) shining from different directions. The surface reconstructed in this way is then used for quantitative skin analysis. Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)	Day 0, Day 30 and Day 60
Skin roughness at Day 30 and Day 60 in comparison to baseline and placebo as assessed by 3D imaging.	Skin roughness measurement using 3D imaging. The Optical 3D is a camera for image acquisition and analysis of the skin. It relies on multi-directional illumination and computer-aided reconstruction of the skin surface, illuminating the surface from different angles and using the differences between these images to reconstruct the surface in three dimensions. The skin topography and the chromophores concentration are derived from the spatial and spectral analysis of the acquired image data, obtained by illuminating the skin with light emitting diodes (LEDs) of different wavelengths (455 to 625 nm) shining from different directions. The surface reconstructed in this way is then used for quantitative skin analysis. Instrument: Antera 3D® (Miravex Limited, Dublin, Ireland)	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 scale.	The Allergan Skin Roughness Scale is a validated, 5-point photo-numeric scale used by clinicians to visually assess the texture of facial skin, particularly in the midface area. It grades skin roughness from 0 (smooth) to 4 (extremely coarse), using a set of images and detailed descriptors to provide objective, consistent, and reliable assessments.	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, redness and pimples on skin at Day 30 and Day 60.	A subjective self-assessment questionnaire will be administered to participants to understand participant perception of efficacy of the product.	Day 0, Day 30 and Day 60
Tolerability of the Investigational Product as assessed by self-assessment questionnaire.	Self-assessment questionnaire for in-use tolerance to capture any systemic side effects.	Day 60

Collaborators and Investigators

• Sponsor: Circul'Egg

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2026
• Primary Completion (Estimated): May 26, 2026
• Study Completion (Estimated): May 26, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: March 20, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: CL/142/1125/STU; CTRI/2026/02/102872 (Registry Identifier: CTRI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No