| CTRI Number |
CTRI/2022/08/044565 [Registered on: 02/08/2022] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Cosmeceutical] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
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. |
|
Scientific Title of Study
|
An open-label, single-arm study to evaluate the efficacy and safety of a Body Firming Cream and Under Eye Gel in lactating female (post pregnancy mother having 0 month to 36 months old baby) subjects and only Under Eye Gel in healthy pregnant female (1st and 2nd trimester) subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B00918 Version: 01, Dated 15 Jul 22 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Joshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
GUJARAT
380054
India |
| Phone |
8000085049 |
| Fax |
917966219549 |
| Email |
pjoshi@ofacto.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director - Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
917966219549 |
| Email |
ssethi@ofacto.com |
|
|
Source of Monetary or Material Support
|
| Zydus Wellness Ltd.
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
|
|
Primary Sponsor
|
| Name |
Zydus Wellness Ltd |
| Address |
Plot No 115/5 TP Scheme No 51,
Beside Bliss Apartment,
Opp Viola Apartment,
Ambli Bopal Road,
Ahmedabad 38001, India |
| Type of Sponsor |
Other [Health and Hygiene] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth Joshi |
Cliantha Research |
Consumer Research Department,
Garden View Corporate House No 7,
Opp Auda Garden,
Bodakdev, Ahmedabad 380054, India
Ahmadabad
GUJARAT |
8000085049
917966219549
pjoshi@ofacto.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| OM |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R238||Other skin changes, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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.
|
| Comparator Agent |
Not Applicable |
Not Applicable |
| Intervention |
Under Eye Gel |
Approx. 0.2 gm of test product to be applied under the eye contour. Product to be used twice daily for a duration of 42 days. |
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 Investigator’s Global Assessment Scale.
6) Dermatological assessment of under eye fine lines using Allergan Fine Lines Scale. |
Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of skin elasticity of thighs, buttocks and hips using Cutometer. |
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. |
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. |
Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84 |
| Assessment of under eye dark circles and under eye fine lines by image analysis. |
Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84 |
| Subject Satisfaction Questionnaire and Product Response Index (Perception about Product). |
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 CR |
Baseline, Day 14, Day 28, Day 42, Day 56 and Day 84 |
|
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Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "65"
Final Enrollment numbers achieved (India)="65" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/08/2022 |
| Date of Study Completion (India) |
23/02/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="24" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The potential
subjects will be screened as per the inclusion and exclusion criteria only
after obtaining written informed consent from the subjects.
There are total 7 visits in the study i.e.
·
Visit 01:
Screening Visit (within 30 days prior to day 01)
·
Visit 02:
Enrollment (Day 01)
·
Visit 03:
Evaluation phase (Day 14)
·
Visit 04:
Evaluation phase (Day 28)
·
Visit 05:
Evaluation phase (Day 42)
·
Visit 06:
Evaluation phase (Day 56)
·
Visit 07:
Evaluation phase and End of the study (Day 84)
Before entering the facility, at security check-post,
subjects will be asked for pre-entry scrutiny check for COVID-19 symptoms.
Study can be conducted in multiple batches (set of subjects) in order to follow
the norms of covid-19 restrictions.
Instrumental assessment, dermatological assessments
and questionnaires will be assessed. Photographs of the affected area will also
be taken. Safety will be assessed throughout the study by monitoring of adverse
events. |