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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2026/02/102872 | Registry Identifier | CTRI |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMC-CAP-2025A | Experimental |
| |
| EMC-CAP-2025B | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMC-CAP-2025A | Dietary Supplement | EMC-CAP-2025A 300 mg per capsule Regimen: 1 capsule per day after meals Route: Oral Duration: 60 days |
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| 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 |
| 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) |
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Inclusion Criteria:
Individuals who are willing to understand and sign a written informed consent form prior to the study.
Healthy male and female individuals aged between 30 to 55 years (both values included).
Individuals showing symptoms of aging, with mild to moderate wrinkles in crow's feet area based on PI discretion.
Individuals with any one of the following skin conditions along with mild to moderate wrinkles:
Individuals willing to maintain stable dietary patterns and maintain adequate hydration every day throughout the study
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.
Willingness to participate in the study and comply with the study procedures and required visits.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.L.A.I.M.S. Private Limited | Mumbai | India |
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| EMC-CAP-2025B | Dietary Supplement | Placebo |
|
| 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.
| 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 |