To study the effect of an Oral Supplement on various skin aging parameters and any unwanted side-effect (if any) in women.
Phase 4
Completed
- Registration Number
- CTRI/2018/07/014808
- Lead Sponsor
- Axys Nutrition Products Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
Voluntary women with mild to moderate wrinkles.
- Having at least 1 hyperpigmented spot.
- Having undereye dark circles.
- Food habit - Non-vegetarians or consented vegetarian.
- Subjects not on any nutritional supplement or not consuming any therapeutic medication for any disorder for last 45 days.
Exclusion Criteria
- Subjects with any chronic illness or any clinical condition.
- Subjects showing abnormal levels in blood test parameters.
- Pregnant Women (as confirmed via UPT) and lactating women.
- Subject likely to undergo any surgery in the period of the study.
- Subjects who have used a collagen peptide containing supplement in the past 6 months.
- Subjects consuming tobacco.
- Obese individuals (BMI >30).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical Evaluation of Wrinkles in crowâ??s feet area, Blemishes and Undereye dark circle <br/ ><br> <br/ ><br>Instrumental evaluation using 3D imaging (Wrinkles, blemish, Average Pore volume and Porosity index, Roughness), MoistureMeter SC (hydration), Vapometer (TEWL) and Cutometer (firmness and elasticity) <br/ ><br> <br/ ><br>Subjective self-assessment for product efficacy (Not at Day -30)Timepoint: Day -30 <br/ ><br>Day 0 <br/ ><br>Day 30 <br/ ><br>Day 60
- Secondary Outcome Measures
Name Time Method Self-evaluation questionnaire to capture tolerabilityTimepoint: Day 0 <br/ ><br>Day 30 <br/ ><br>Day 60