None listed
Conditions
Interventions
Intervention1: Fiber interlaced liposomal (FIL) vitamin C Capsules Oral (Active): FIL VITAMIN C 350 mg capsules is administered twice daily 30 minutes before food, Duration-84 days.
Intervention2: Fib
Sponsors
Vidya Herbs Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory female subjects of 35-60 years with a Body Mass Index (BMI) of 18.5 to 24.9 kgm2. And having dry skin. 2. Subjects considered as healthy by Principal Investigator through medical history and laboratory results during screening. 3. Subjects who are having 3-6 degrees wrinkles in the crow s-feet area, with global photo damage score between 3 and 6. 4. Subjects who are not taking Vitamin supplements. 5. Fitzpatrick Skin Photo types III to V 6. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face. 7. Subjects voluntarily agree to participate, sign written informed consent and comply with study protocol. 8. Subjects willing not to undergo Skincare therapy, Laser therapy, BotoxFiller, ETC during the study period. 9. Subjects willing to not to take food that could effect on skin condition and continue their normal diet during the study period 10. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrhoeic for at least 1 year or had a hysterectomy and or bilateral oophorectomy.
Exclusion criteria
Exclusion criteria: 1. Subjects underwent treatment for COVID 19 within last 3 months or tested positive during the study will be excluded. 2. Individuals with sensitive or hypersensitive skin. 3. Psoriasis patients taking immunosuppressive drugs, severe atopic dermatitis patients. 4. Subjects with a history of photo allergy or photosensitization for minimal erythema test. 5. Expectation of any surgery during the study period. 6. Subject with history of allergies to cosmetics, pharmaceutical products, or foods 7. Use of topical retinoid, any other anti wrinkle steroid products and cosmetic products containing AHA, BHA within the 3 months prior to initiation of the study. 8. Subjects who are using moisture rich cosmetic products within the 2 weeks prior to study initiation. 9. Subjects with uncontrolled Diabetes and Hypertension 10. Subjects with history of renal or liver impairment, any endocrine, inflammatory, cardiovascular, gastro intestinal, neurological, psychiatric, neoplastic or metabolic disease. 11. Subjects suffering from COPD or having history of any respiratory or breathing disorders. 12. Subjects with HIV Positive status. 13. Alcohol intake greater than 2 standard drinks per day or use of recreational drugs such as cocaine, methamphetamine, marijuana, etc. and smokers. 14. Participation in any other trials involving investigational or marketed products within 30 days prior to the screening visit. 15. Clinically significant or abnormal laboratory results during screening. 16. Any condition judged by the investigator to be unsuitable for participation in the study. 17. Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcomes: Change from baseline to the end of the study period in: 1. Skin elasticity by Cutometer. 2. Skin collagen measurement by Ultrasound. 3. Skin hydration by Corneometer. 4. Trans epidermal water loss (TEWL) by Tewameter. 5. Erythema index (EI) and melanin index (MI) by Mexameter.Timepoint: Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcomes: Change from baseline to the end of the study period in: 1. Participants degree of satisfaction (Product Efficacy Questionnaires, Product Characteristics Questionnaires and Product Acceptability Questionnaires). 2. Skin stripping on dorsal region of hand 10 layers for detection of SOD and catalase activity.(Visit2(day 0), Visit 3(Week 1), Visit 4(Week 6), Visit 5(week 12))Timepoint: Visit 4(Week 6), Visit 5(week 12) | — |
Countries
India
Contacts
Public ContactDr Ashok Godavarthi
Radiant Research Services Pvt. Ltd
Outcome results
None listed