To study the effect of a product on wrinkles in volunteers.
- Registration Number
- CTRI/2022/10/046168
- Lead Sponsor
- Zywie Ventures Pvt. Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Voluntary women and/or men from 35 years to 55 years of age.
2. Volunteers with moderate wrinkles in crowâ??s feet area.
3. Having apparently healthy skin on test area.
4. Willingness to discontinue the use of other cosmetic products on face/forearms during the course of the study.
5. Subjects not on any nutritional supplement or not consuming any therapeutic medication for any disorder for last 45 days.
6. Subjects with no known allergies to foods & other substances
7. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures.
8. Having signed a Consent Form, after being informed orally and in writing of all information concerning the study procedures and study objectives.
9. Willingness to avoid intense UV exposure as far as possible for the entire study duration.
1. Pregnant women by UPT /lactating women.
2. Subjects showing abnormal levels in blood test parameters. (Subjects having abnormal values but are Clinically fit to participate in the trial would be enrolled in the study at Principal Investigatorâ??s Discretion).
3. Any cutaneous conditions on test site (scars, moles, papules etc).
4. Any clinically significant systemic or cutaneous disease, which may interfere with study treatments or procedures.
5. Subjects with known allergies to ingredients of the product, milk products, egg, gluten etc and wheat flour.
6. Subjects with substance abuse (alcohol, drugs etc.).
7. Subject likely to undergo any surgery in the period of the study.
8. Subjects who were on any other experimental Investigational study within last 1 month as identified during screening on visit 1 (V1).
9. Subjects having any hard damage to skin (e.g., excessive sunburn or suntan).
10. Subjects who have used a collagen peptide containing supplement in the past 6 months.
Subjects who have taken high doses of vitamin C ( >500 mg a day) or any other high dose antioxidant product in the past 1 month.
11. Individuals with chronic Gastrointestinal issues such as frequent indigestion, GERD.
Subjects with severe acne and other major conditions.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the efficacy of a Collagen Building Blend Nutraceutical product for facial skin anti- ageing effect in a mixed population versus initial state and placebo. <br/ ><br>Timepoint: Screening, Day 0, Week 4, Week 8
- Secondary Outcome Measures
Name Time Method To evaluate the in-use tolerance of the product.Timepoint: Screening, Day 0, Week 4, Week 8