| CTRI Number |
CTRI/2012/06/002710 [Registered on: 04/06/2012] Trial Registered Retrospectively |
| Last Modified On: |
26/12/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Skin Lightening Cream] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of fairness cream in healthy human volunteers compared to placebo |
|
Scientific Title of Study
|
A Phase II, randomized, double blind placebo controlled study to evaluate the efficacy and safety of Skin Lightening cream in healthy human volunteers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MSCR/CWSL/2012-01, version 1.0 dated 05-Mar-2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Prinicpal Investigator |
| Affiliation |
MS CLINICAL RESEARCH PVT.LTD |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore.
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore.
Bangalore
KARNATAKA
560025
India |
| Phone |
9180-40917253 |
| Fax |
9180-41125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Prinicpal Investigator |
| Affiliation |
MS CLINICAL RESEARCH PVT.LTD |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore.
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore.
Bangalore
KARNATAKA
560025
India |
| Phone |
9180-40917253 |
| Fax |
9180-41125934 |
| Email |
mukta.sachdev@mscr.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Prinicpal Investigator |
| Affiliation |
MS CLINICAL RESEARCH PVT.LTD |
| Address |
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore.
MS CLINICAL RESEARCH PVT. LTD, Mezzanine Floor, Classic Court, 9/1 Richmond Road, Bangalore.
Bangalore
KARNATAKA
560025
India |
| Phone |
9180-40917253 |
| Fax |
9180-41125934 |
| Email |
mukta.sachdev@mscr.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sami Labs |
| Address |
19/1 & 19/2, I main, II phase, Peenya Industrial Area, Bangalore, Karnataka, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt. Ltd |
Classic Court, 9/1,Richmond Road,
Bangalore
KARNATAKA |
91-80-40917253
91-80-41125934
mukta.sachdev@mscr.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-Aditya,Ahmedabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Skin Lightening study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
Frequency:Twice daily- morning and night. Dose:0.5 gms per application. Duration of application: 42 days |
| Intervention |
Skin Lightening Cream |
Frequency:Twice daily- morning and night. Dose:0.5 gms per application. Duration of application: 42 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
• Male and Female subjects in generally good health
• Subjects of skin types III, IV, and V.
• Subjects age group 18 - 55 years
• Subjects willing to give a written informed consent and come for a regular follow up.
• Subject willing to abide by and comply with the study protocol
• Subject has not participated in a similar investigation in the past four weeks.
• Subject should be willing to abstain from spa treatments/facials throughout the study period
|
|
| ExclusionCriteria |
| Details |
• A known history or present condition of allergic response to any cosmetic products.
• Subject having skin diseases (e.g. moderate to severe acne vulgaris face or nodulocystic acne, psoriasis, active atopic dermatitis, melasma, lichen planus pigmentosus/ Achy dermatosis, pigmented contact dermatitis or other cutaneous manifestations), which will interfere with the test readings.
• Subjects on oral medications (e.g. steroids, anti-oxidant) which will compromise the study.
• Systemic treatment which may modify the cutaneous state on the day of inclusion or in the previous 30 days, including retinoid therapy, photosensitizing drugs.
• Subjects not willing to discontinue other topical fairness, anti ageing, anti wrinkle facial products.
• Subjects who are pregnant, lactating or nursing.
• Hypersensitivity to any component of the tested products.
• History of intense sun exposure.
• Chronic illness which may influence the cutaneous state.
• Subject participating concurrently in any other cosmetic or therapeutic trial.
• Any underlying uncontrolled medical illness such as diabetes mellitus, hypertension, liver disease or history of alcoholism, HIV, hepatitis, or any other serious medical illness.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
a. Primary objective
To assess product efficacy by overall lightening of skin tone in comparison to baseline and placebo by following parameters:
• Dermatologist’s assessment
• Instrumental measurements- mexameter, chromameter
|
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
b. Secondary objective
• To assess product performance in reduction of dark spots, blemishes and marks in comparison to baseline and placebo by evaluating photographically with Imaging system - Image pro II
• Assessment for adverse events |
6 Weeks. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2012 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
It is a Phase II, randomized double blind placebo controlled study to evaluate the efficacy and safety of skin lightening cream in healthy human volunteers.
The study aims at
a. Primary objective
To assess product efficacy by overall lightening of skin tone in comparison to baseline and placebo by following parameters:
· Dermatologist’s assessment
· Instrumental measurements- mexameter, chromameter
b. Secondary objective
· To assess product performance in reduction of dark spots, blemishes and marks in comparison to baseline and placebo by evaluating photographically with Imaging system - Image pro II
· Assessment for adverse events
|