effect of Kanak taila in reducing wrinkles and promoting skin brightening.

Phase 4

Completed

• Registration Number: CTRI/2021/09/036560
• Lead Sponsor: Ms Ozone Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-20
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

Volunteers meeting the following criteria will be enrolled:

ïâ??· Between the age of 18-65 years;

ïâ??· Available for 3 study visits;

ïâ??· Fine lines/wrinkles: Allergen fine lines (ââ?°Â¥ grade 1)

ïâ??· Individuals who are willing to provide written informed consent

ïâ??· Individuals willing not to wear makeup or use skin care products other

than the study products the day of the study visits;

ïâ??· Individuals willing to discontinue using current skincare products and

only use study products for the study duration.

ïâ??· Individuals willing to refrain from sun tanning / sun bathing for the study

duration

Exclusion Criteria

Volunteers will be excluded from the study if they meet any of the criteria listed

below:

ïâ??· Any medically diagnosed chronic skin problems on their face (e.g.,

psoriasis, eczema, seborrheic dermatitis, or chronic cystic acne, etc.)

ïâ??· Diagnosed with known allergies to facial skin care products

ïâ??· Have undergone dermatological skin rejuvenation procedures such as

light-therapies (lasers, radiofrequency and other lights treatments ) or

such as collagen or other facial tissue augmentation, fillers, or retail

micro dermabrasion on the face within the last 1 year preceding the

baseline visit and intended to receive them during the study period

ïâ??· Have planned surgeries or invasive procedures during the course of the

study.

ïâ??· Excessively tanned face before the baseline visit and who intend to

excessively be exposed to sun.

ïâ??· Have sunburned skin

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy Endpoints <br/ ><br>ïâ??· Reduction of fine lines according to Allergan Fine Lines Scale (Grade <br/ ><br>0 to 4) <br/ ><br>ïâ??· Subjective Improvement in fine lines, skin whitening and skin <br/ ><br>smoothening scoring <br/ ><br>Timepoint: baseline, 4 weeks and 8 weeks <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Safety/Tolerability Endpoints <br/ ><br>ïâ??· No visible Erythema, oedema, , scaling, dryness, burning, tingling <br/ ><br>stinging & itching <br/ ><br>ïâ??· Monitoring of adverse events throughout the course of the study. <br/ ><br>Timepoint: 3 months