| CTRI Number |
CTRI/2014/01/004310 [Registered on: 15/01/2014] Trial Registered Retrospectively |
| Last Modified On: |
31/12/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Soap] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study to evaluate the efficacy and safety of a Skin Lightening Soap for the treatment of Hyper Pigmentation in adults |
|
Scientific Title of Study
|
A Prospective, Open-labeled, Clinical Study to evaluate the efficacy and safety of a Skin Lightening Soap for the treatment of Hyper Pigmentation in adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ICBio/CR/KOP/0415/24,Version 01 dated 14.MAY.2013 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr J Prasad |
| Designation |
Consultant Dermatologist |
| Affiliation |
Revive Cosmetic Clinique |
| Address |
Revive Cosmetic Clinique No.72, 2nd Road, Nandidurga Extn, Jayamahal Bangalore 560 046
Bangalore
KARNATAKA
560 046
India |
| Phone |
9844061806 |
| Fax |
|
| Email |
revive_cos@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harisha S |
| Designation |
Director |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Harisha S |
| Designation |
Director |
| Affiliation |
ICBio Clinical research Pvt Ltd |
| Address |
ICBio Clinical Research Pvt. Ltd. #16, ICBio Tower, Yelahanka Main Road Chikkabetahalli, Vidyaranyapura,Bangalore.
Bangalore
KARNATAKA
560097
India |
| Phone |
9900111997 |
| Fax |
|
| Email |
harish@icbiocro.com |
|
|
Source of Monetary or Material Support
|
| Kumar Organic Products Research Center |
|
|
Primary Sponsor
|
| Name |
Kumar Organic Products Research Center |
| Address |
Plot No.36, Road No. 3 Road No.3&5, Jigani Industrial Area, Anekal Taluk, Bangalore - 562 106 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 J Prasad |
Revive Cosmetic Clinique |
#72, 2nd Road, Nandidurga Extn, Jayamahal Bangalore – 560 046
Bangalore
KARNATAKA |
9844061806
revive_cos@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Clinical IEC Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hyper pigmentation disorders such as Melasma and lentigo (mild to moderate). |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Skin Lightening Soap |
Deep wash: Wash the face, neck and arms with the provided soap two times per day morning and in the evening for 90 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Males and females of age group 18-60 years Subjects who are willing to give written informed consent.
Subjects with Fitzpatrick Skin types II to IV Subjects with hyper pigmentation disorders such as Melasma and lentigo (mild to moderate).
Patient is willing and able to comply with all trial requirements |
|
| ExclusionCriteria |
| Details |
Having major treatment, including topical hydroquinone or tretinoin, cryotherapy, electro-surgery, trichloroacetic acid application, laser or intense pulsed light, in the 3 months before the beginning of the study Past history of allergy to whitening cosmetic products
Past history of atopic dermatitis Habit of going to the tanning salon or frequent sun exposure longer than 4 hours per day
Present history of mental diseases
Previous participation in a clinical trial within 6 months.
Pregnant or lactating woman
Certain medications that may interfere with the study medication (these will be identified by the study Investigator). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in score of the Melasma area and severity index (MASI) (Baseline to EOT) Mexameter analysis (Melanin,erythema contents) (Baseline to EOT) Chromameter (L,a and b values) (Baseline to EOT) To assess the efficacy of skin lightening soap for the treatment of hyper pigmentation in adults in comparison to base line by following parameters(Baseline to EOT)
Dermatologists assessment (Baseline to EOT) Shade card assessment(Baseline to EOT) |
Baseline to end of the treatment
(Day 90) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Physician global improvement assessment scores.
Melasma Quality of life questionnaire before and after the treatment. (Baseline to EOT) To study the performance of the skin lightening soap in imparting the
skin whitening by subject self assessment during the visits (Baseline to EOT) - patient satisfaction using grading scale. |
All Visits |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/11/2013 |
| Date of Study Completion (India) |
06/02/2014 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A Prospective, Open-labeled, Clinical Study to evaluate the efficacy and safety of a Skin Lightening Soap for the treatment of hyper pigmentation in adults.
Primary Objective: To assess the efficacy of „Skin Lightening Soap‟ for the treatment of hyper pigmentation disorders in adults.
Secondary Objective: To evaluate the safety of Skin Lightening Soap‟ for the treatment of hyper pigmentation disorders in adults.
Primary endpoints Changes in score of the Melasma area and severity index (MASI) (Baseline to EOT)
Mexameter analysis (Melanin,erythema contents) (Baseline to EOT)
Chromameter (L,a and b values) (Baseline to EOT)
To assess the efficacy of skin lightening soap for the treatment of hyper pigmentation in adults in comparison to base line by following parameters(Baseline to EOT)
Dermatologists assessment (Baseline to EOT) Shade card assessment(Baseline to EOT)
Secondary Endpoints Physician global improvement assessment scores at Day 1 to Day 90
skin whitening by subject self assessment during the visits (Baseline to EOT) - Patient satisfaction using grading scale. |