A clinical study to evaluate the safety and efficacy of a food supplement in improving skin health
- Registration Number
- CTRI/2022/11/047326
- Lead Sponsor
- aturetech Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Ambulatory, male and female subjects of 40-60 years age with a Body Mass Index (BMI) of 20 to 29 kg/m2.
2. Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening.
3. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy.
4. Fitzpatrick Skin Photo types III to V
5. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face.
6. Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol.
7. Subjects willing not to undergo Skincare therapy, Laser therapy, Botox/Filler, ETC during the study period.
8. Subjects willing to not to take food that could effect on skin condition and continue their normal diet during the study period
9. Subjects who are having 3-6 degrees wrinkles in the crowâ??s-feet area, with global photodamage score between 3 and 6, and water content 170 or less on both left and right cheeks.
1. Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
2. Expectation of any surgery during the study period.
3. Subject with history of allergies to cosmetics, pharmaceutical products, or foods containing ingredients included in the study supplement.
4. Use of topical retinoids, any other anti-wrinkle steroid products and cosmetic products containing AHA, BHA within the 3 months prior to initiation of the study.
5. Subjects who are using moisture-rich cosmetic products within the2 weeks prior to study initiation.
6. Subjects with uncontrolled Diabetes (FPG >126 mg/dL) and Hypertension (Systolic > 140 mmHg and Diastolic >90 mmHg).
7. Subjects with history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro-intestinal, neurological, psychiatric, neoplastic or metabolic disease.
8. Subjects suffering from COPD or having history of any respiratory or breathing disorders.
9. Subjects with HIV Positive status.
10. Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) and smokers.
11. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit.
12. Clinically significant or abnormal laboratory results during screening.
13. Any condition judged by the investigator to be unsuitable for participation in the study.
14. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method