TO CHECK THE EFFECT OF SKIN ANTI AGEING NUTRICOSMECTIC PRODUCT IN WOMEN

Completed

• Conditions: with dry skin.Non vegetarians or consented vegetarian.

• Registration Number: CTRI/2011/10/002040
• Lead Sponsor: Meiji India Private Ltd

Brief Summary

·         This study will have 2 test products – a skin antiageing Nutricosmetic and 1 placebo.

·         During screening visit, following documentation of written informed consent of the volunteer, a detailed history will be taken from the volunteers by the Investigator.

·         Medical History and prior treatments taken by the volunteer would be recorded at screening visit.

·         Voluntary women in the age group of 30 – 50 years and with dry skin as confirmed by MoistureMeter SC readings will be recruited for the study. Dry skin readings via MoistureMeter SC lies between 0 – 20. Hence volunteers whose MoistureMeter SC readings are below 20 will be included. MoistureMeter SC readings for skin hydration will be taken on cheek.

·         All the subjects will undergo a blood test to determine her general health conditions for screening only.

·         At **Visit 1** (D0) and Visit 2 (Week 4) the volunteers face will be washed with Cetaphil and volunteer will be acclimatized under controlled conditions (Temperature: 20â 22o C) and (Humidity: 40â60%) for 1 hour.

·         Measurements would be as follows: Silicon imprints for skin roughness and wrinkle evaluation of crows feet area

·         Spectrophotometer readings for skin whitening and Cutometer readings for skin elasticity will be taken on cheeks.

·         MoistureMeter SC readings for skin hydration will be taken on cheek.

·         Follow up visit will be at week 1 at a decided site and 4 weeks.

·         All measurements will be taken at both visits. Visit 1 (D0) and Visit 2 (4 weeks).

·         Digital Photographs will be taken at both visits.

**Self Evaluation Questionnaire will be taken every week. At Week 1, the volunteers will be called to a previously specified place to fill in the self evaluation questionnaire. At week 2 and week 3 it will be taken telephonically. Volunteer will not be asked to come to the study centre for a visit.**

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-11
• Study Completion: 2011-05-12
• Last Update Posted: 2018-11-26

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• Women with dry skin confirmed by taking 2.
• MoistureMeter SC readings (MoistureMeter SC Readings<20).
• Phototype IV and below.
• 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.
• Subjects with no known allergies to foods & other substances.
• Cooperating, informed of the need and duration of the study procedures, and ready to comply.
• Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives.

Exclusion Criteria

• 1.Subjects with any chronic illness or any clinical condition.
• 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 Investigator’s Discretion).
• 3.Pregnant Women (as confirmed via UPT) and lactating women.
• 4.Subjects with known allergies to food items like fish gelatine, soya, milk and milk products, egg, gluten etc and wheat flour.
• 5.Subjects with substance abuse (alcohol, drugs etc.) 6.Subject likely to undergo any surgery in the period of the study 7.Subjects who were on any other experimental Investigational study within last 1 month as identified during screening on visit 1 (V1).
• 8.Subjects unable to comply with the protocol in the opinion of Investigators.
• 9.Subjects who were not to maintain regular (orderly) life.
• 10.Subjects having any hard damage to skin (e.g. excessive sunburn or suntan).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Reduction in skin roughness and Wrinkle evaluation.	At Day 0 and Week 4
2. Skin Whitening effect evaluation	At Day 0 and Week 4
3. Skin elasticity	At Day 0 and Week 4
4. Skin Hydration	At Day 0 and Week 4
5. Self Evaluation	At Day 0 and Week 4

Secondary Outcome Measures

Name	Time	Method
Tolerance Evaluation	Week 4

Trial Locations

Locations (1)

C.L.A.I.M.S. Pvt. Ltd.; 🇮🇳 Mumbai, MAHARASHTRA, India

C.L.A.I.M.S. Pvt. Ltd.

🇮🇳Mumbai, MAHARASHTRA, India

Dr Rajiv Joshi

Principal investigator

rsjdr@rediffmail.com