| CTRI Number |
CTRI/2014/03/004476 [Registered on: 14/03/2014] Trial Registered Retrospectively |
| Last Modified On: |
24/01/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Instrumental Evaluation of Cellulite affected skin |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of cellulite affected and Normal Skin on healthy human volunteers. |
|
Scientific Title of Study
|
Evaluating Non-Invasive Measurement Tools to Differentiate Cellulite Affected Skin from Normal Skin on Healthy Human Volunteers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/ITCS/2013-13,version 1.0, 11th Nov 2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt.Ltd. |
| Address |
Mezzanine Floor, Classic Court, 9/1 Richmond Road,Bangalore
Bangalore
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt.Ltd. |
| Address |
Mezzanine Floor, Classic Court, 9/1 Richmond Road,Bangalore
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
sapna.r@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr SapnaR |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt.Ltd. |
| Address |
Mezzanine Floor, Classic Court, 9/1 Richmond Road,Bangalore
KARNATAKA
560025
India |
| Phone |
08040917253 |
| Fax |
08041125934 |
| Email |
sapna.r@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ITC R D Centre |
| Address |
Peenya Industrial area,I Phase, Peenya Bangalore- 560058 Karnataka, India |
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sapna R |
MS Clinical Research Pvt Ltd |
Mezzanine Floor,
Classic Court, 9/1 Richmond Road,Bangalore
Bangalore
KARNATAKA |
08040917253
08041125934
sapna.r@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinicom, Independent Ethics Committee, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
cellulite affected subjects and normal subjects. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
•Subjects willing to give written informed consent and abide by the study protocol.
•10 healthy female subjects in the age group of 20 to 50 yrs.
•At least 5 subjects with cellulite on at least one of the arms/ thighs and the remaining 5 with normal skin.
•Subjects with no medical history of disease / medical condition/ concurrent illness/ pre-existing or dormant dermatologic condition that could interfere with the study results.
•Subjects who are not pregnant or nursing.
•Subjects who are willing to abstain from using any cosmetic product on the identified sites on the day of study.
|
|
| ExclusionCriteria |
| Details |
• Subjects who are pregnant or lactating.
• Subjects having skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations), which would interfere with the test readings.
• Subjects on medications (e.g. steroids or antihistamines), which could compromise the study results.
• Subjects with scars, cuts/ wounds/ scratches on the potential test sites (Brachium region, Femoral regions and Volar forearm), which could interfere with the test readings.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study for difference in skin thickness, moisture, elasticity, viscoelasticity, smoothness, firmness and color recovery in cellulite accumulated skin vs. non cellulite accumulated skin through non-invasive instrumental measurements and visual evaluation. |
single visit evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the correlation between the varied evaluation tools available to measure skin cellulite. |
Single visit evaluation |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/11/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="5" |
|
Recruitment Status of Trial (Global)
|
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)?
|
|
Brief Summary
|
|
An observational/
non-interventional study.
|
|
Total
10 healthy human adult female subjects, of which at least 5 with visible
cellulite on upper arms and / or thighs and remaining with no cellulite.
|
|
Dermatologist’s
visual assessment , Instrumental
measurements- 1
day of evaluation for each subject. Subjects might need to visit on an
additional day for screening and enrolment.
|
|