Clinical study to evaluate the safety and efficacy of Body Firming Cream and Under Eye Gel in lactating females and only Under Eye Gel in healthy pregnant females.

Not Applicable

Completed

• Conditions: Health Condition 1: R238- Other skin changes

• Registration Number: CTRI/2022/08/044565
• Lead Sponsor: Zydus Wellness Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-02-23
• Last Update Posted: 1 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 65

Inclusion Criteria

1)Lactating females

a.with diagnosis of cellulite with grades I to III according to Cellulite Severity Grading scale.

b.with stage 1 and stage 2 according to Nurnberger-Muller Cellulite Classification Scale

c.with Grade 2 and Grade 3 under eyes dark circles and under eyes puffiness as determined by 6-point grading scale.

d.Subjects having history of delivery within 42 weeks.

2)Healthy pregnant females

a.with Grade 2 and Grade 3 under eyes dark circles and under eyes puffiness as determined by 6-point grading scale.

b.Primipara (woman who is giving birth for the first time) subjects, who are diagnosed as pregnant female by gynaecologist.

Exclusion Criteria

1)Subjects having varicose veins or history of phlebitis in the cellulite area or condition such as psoriasis, eczema, erythema, edema, scars, wounds and other visible lesions.

2)Subjects who have used some kind of cellulite-treatment in the last 30 days before beginning of the study or those who underwent any kind of surgical procedure in area of treatment, in past three months before the study.

3)Participation in a similar clinical study within the previous 90 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Dermatological assessment of cellulite of thighs, buttocks and hips using Nurnberger-Muller Scale. <br/ ><br>2)Measurement of circumference of the thighs, buttocks and hips. <br/ ><br>3)Dermatological assessment of skin tonicity of the thighs, buttocks and hips using Cellulite Severity Grading scale. <br/ ><br>4)Dermatological assessment of under eyes dark circles using 6-point grading scale. <br/ ><br>5)Dermatological assessment of under eye puffiness using Investigatorâ??s Global Assessment Scale. <br/ ><br>6)Dermatological assessment of under eye fine lines using Allergan Fine Lines Scale.Timepoint: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84

Secondary Outcome Measures

Name	Time	Method
Assessment of under eye dark circles and under eye fine lines by image analysis.Timepoint: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84;Subject Satisfaction Questionnaire and Product Response Index (Perception about Product).Timepoint: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84;6)Digital photographs of thighs, buttocks and/or hips and photographs of under eye area will be taken using Visia CRTimepoint: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84;Assessment of skin barrier function of thighs, buttocks and hips using TEWAmeter/Vapometer.Timepoint: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84;Assessment of skin elasticity of thighs, buttocks and hips using Cutometer.Timepoint: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84;Assessment of skin hydration of thighs, buttocks and hips using Corneometer/ Moisturemeter SC.Timepoint: Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84