| CTRI Number |
CTRI/2015/04/005697 [Registered on: 15/04/2015] Trial Registered Retrospectively |
| Last Modified On: |
21/10/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Observational Study to Evaluate Efficacy, Safety and Tolerability of Z-n-butylresorcinol in Patients with Melasma |
|
Scientific Title of Study
|
An Open Label, Single Arm, Observational Study to Evaluate Efficacy, Safety and Tolerability of 4-n-butylresorcinol in Patients with Melasm
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrManjula S |
| Designation |
Vice president -Medical services |
| Affiliation |
Micro Labs Ltd |
| Address |
No 27 Race course Road
Bangalore Karnataka
India
No 27 Race course Road
Bangalore Karnataka
India
Bangalore
KARNATAKA
560001
India |
| Phone |
|
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DrManjula S |
| Designation |
Vice president -Medical services |
| Affiliation |
Micro Labs Ltd |
| Address |
No 27 Race course Road
Bangalore Karnataka
India
No 27 Race course Road
Bangalore Karnataka
India
KARNATAKA
560001
India |
| Phone |
|
| Fax |
|
| Email |
drmanjula@microlabs.in |
|
Details of Contact Person
Public Query
|
| Name |
DrLokesh |
| Designation |
Manager-Medical services |
| Affiliation |
Micro Labs Ltd |
| Address |
No 27 Race course Road
Bangalore Karnataka
India
No 27 Race course Road
Bangalore Karnataka
India
Bangalore
KARNATAKA
560001
India |
| Phone |
|
| Fax |
|
| Email |
lokeshkumar@microlabs.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Micro Labs Ltd |
| Address |
No 27 Race course road
Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Micro Labs Ltd |
No 27 Race course road
Bangalore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrMadan Mohan |
Dr.B.R Ambedkar Medical college |
Dr B R Ambedkar Medical College 1 st floor Department of dermatology Room number 3 Kadugondanahalli Bangalore 560045
Bangalore
KARNATAKA |
080-25476498
derma_madanmohan@yahoo.co.in |
| DrAdarsh gowda |
Kempegowda Institute of Medical Sciences |
Kempegowda Institute of Medical Sciences Department of dermatology ground floor no 10 K.R Road, V.V Puram, Bangalore 560 004
Bangalore
KARNATAKA |
080-26613225
adarshgowda@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee, Dr. B.R.Ambedkar Medical College situated at Kadugondanahalli, Bangalore-560045, Karnataka India |
Approved |
| KIMS Institutional Ethics Committee, Kemegowda Institute of Medical Sciences, Institutional ethics committee, Banashankari, 2nd stage, Bangalore 560070 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Melasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
4 n Butylresorcinol |
Tyrosinase and TRP-1 inhibitor found useful in melasma and hyperpigmentation. Drug to be applied topically over the affected areas twice daily for a period of 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
•Subjects with melasma who are either treatment naive or were not on any treatment for at-least 6 months
•Subjects aged 18 and above years with melasma
•Subjects with Epidermal type of melasma
•Subjects with Fitzpatrick skin types III, IV and V
•Subjects willing to apply sunscreen during the course of study
•Subjects willing to return for all clinic visits and complete all study-related procedures
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluate the efficacy of 4-n-butylresorcinol in reducing melasma |
4th week and 8th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate safety of 4-n-butylresorcinol based on the adverse effects as mentioned by the patient and evaluated by the investigator.
Assess tolerability of 4-n-butylresorcinol by the investigators
|
8 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/11/2014 |
| 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="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
|
This study is Open Label,
Single Arm, Observational Study to Evaluate Efficacy, Safety and Tolerability
of 4-n-butylresorcinol in 50 subjects with Melasma. The study conducted at two sites in
India. The primary outcome measures efficacy of 4-n-butylresorcinol in reducing
melasma and the secondary outcome measures safety and tolerability of 4-n-butylresorcinol by
the investigators. The total treatment period is 8 weeks
|