Health Condition 1: R238- Other skin changes
Conditions
Interventions
Intervention1: Body Firming Cream: Approx. 4-5 gm of test product to be applied on their hips, buttocks, and thighs and also on legs /abdomen.
Product to be used twice daily for a duration of 84 days
Sponsors
Zydus Wellness Ltd
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)Dermatological assessment of cellulite of thighs, buttocks and hips using Nurnberger-Muller Scale. 2)Measurement of circumference of the thighs, buttocks and hips. 3)Dermatological assessment of skin tonicity of the thighs, buttocks and hips using Cellulite Severity Grading scale. 4)Dermatological assessment of under eyes dark circles using 6-point grading scale. 5)Dermatological assessment of under eye puffiness using Investigatorâ??s Global Assessment Scale. 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Cliantha Research
Outcome results
None listed