| CTRI Number |
CTRI/2012/11/003140 [Registered on: 22/11/2012] Trial Registered Retrospectively |
| Last Modified On: |
22/11/2012 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [cosmetics] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
to evaluate the efficacy of face wash, face scrub and face mask individually and when used in combination, to give salon like fresh fair look everyday on healthy female subjects. |
|
Scientific Title of Study
|
A double blinded, single centered study to evaluate the efficacy of face wash, face scrub and face mask individually and when used in combination, to give salon like fresh fair look everyday on healthy female subjects. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SRC/CD/388, Version: 01, Dated: November 01, 2012 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
The KETs Scientific research centre, Cosmetology division |
| Address |
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081 Tel: 25639644 Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081 Tel: 25639644 Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
9102225639644 |
| Fax |
|
| Email |
meghana@kelkarcosmetology.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Meghana Surve |
| Designation |
Principal Investigator |
| Affiliation |
The KETs Scientific research centre, Cosmetology division |
| Address |
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081 Tel: 25639644 Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081 Tel: 25639644 Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
MAHARASHTRA
400081
India |
| Phone |
9102225639644 |
| Fax |
|
| Email |
meghana@kelkarcosmetology.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Aditi Barve |
| Designation |
Head Skin Evaluation |
| Affiliation |
The KETs Scientific research centre, Cosmetology division |
| Address |
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081 Tel: 25639644 Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081 Tel: 25639644 Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
400081
India |
| Phone |
9102225639644 |
| Fax |
|
| Email |
aditi@kelkarcosmetology.com |
|
|
Source of Monetary or Material Support
|
| Hindustan Unilever Limited |
|
|
Primary Sponsor
|
| Name |
Hindustan Unilever Limited |
| Address |
Research Centre B D Sawant Marg Chakala Andheri (E) Mumbai- 400 099
Tel: 0120-39830000
|
| Type of Sponsor |
Other [Multinational] |
|
|
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 |
| Ms Aditi Barve |
The KETs Scientific research centre, Cosmetology division |
KET Scientific Research Centre, Cosmetology Division, 4th Floor, V. G. Vaze College Campus, Mulund (E), Mumbai – 400 081 Tel: 25639644 Mumbai (Suburban) MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA
Mumbai (Suburban)
MAHARASHTRA |
9102225639644
aditi@kelkarcosmetology.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent Scientific & Ethics Committee, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
face wash study |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
face mask FFM-01 |
dermatologists assessment 30 minutes post face mask FFM-01 application |
| Intervention |
face scrub FFS-01
|
dermatologists assessment 30 minutes post face scrub FFS-01 application |
| Comparator Agent |
Face wash FFW-01 |
dermatologists assessment 30 minutes post face wash FFW-01 application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Female |
| Details |
1. Subject in generally good health.
2. Subject between the ages of 18 and 30 years.
3. Subject has done salon visits two times in the last one year for cleanup and facial.
4. Subject with Fitzpatrick III or IV skin type.
5. Subject having blackheads on face.
6. Subject has not participated in a similar clinical investigation in the past four weeks
7. Subject with no known allergy/ sensitivity to cosmetic products or fragrance and without any skin allergies / infections.
8. Subject not under any dermatologic treatment / prescribed medications.
9. Subject willing to abstain from using any cosmetic product on face, besides the provided product during the entire study course.
10. Subject willing to visit the site at specified frequencies for periodic evaluations.
11. Subject willing to comply with study specific requirements.
12. Subject willing to give a written informed consent and come for regular observation?
|
|
| ExclusionCriteria |
| Details |
A known history or present condition of allergic response to any cosmetic products.
2. Skin disease (e.g. psoriasis, atopic dermatitis or other cutaneous manifestations on the scalp), which would interfere with the test readings.
3. Medications (e.g. steroids or antihistamines), which would compromise the study.
4. Currently or has been undergoing dermatologist facial treatments or procedures within the last 1 month.
5. Subject viewed by the investigator as not being able to complete the study or participating in another study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The objective of this study is to ascertain the salon like instant fairness on the healthy human female subjects. |
Pre product application and 30 mins after each product application in a single day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| and associated skin attributes softness, smoothness, overall appearance, glow, evenness on the healthy human female subjects. |
baseline, 30 minutes post face wash, 30 minutes post face scrub, 30 minutes post face mask application on single day. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
21/11/2012 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
People
experience change in skin conditions constantly, due to environmental factors,
biological factors, psychological state, lifestyle, grooming and other habits
etc. Some of these changes are perceived fast and some over a period of time.
Maintaining a good appearance notwithstanding these changes is a justifiable
consumer “wantâ€. In order to fulfill this want and deliver cosmetically
appealing appearance to skin, people largely resort to cosmetic treatments.
One
cosmetic intervention that is gaining popularity amongst women is a cosmetic
product that would render their skin fair and moisturized. Cosmetic scientists,
world over are constantly searching for solutions to meet the increasing
consumer preferences. |