| CTRI Number |
CTRI/2025/12/098427 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study comparing the effect of Thiamidol cream and triple combination therapy in reducing pigmentation among Melasma patients |
|
Scientific Title of Study
|
Efficacy of topical isobutylamido thiazolyl resorcinol (thiamidol) compared to triple combination therapy in patients with melasma a prospective study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bandreddy Peranti |
| Designation |
Post graduate resident |
| Affiliation |
Alluri Sitarama Raju Academy of Medical Sciences |
| Address |
Room no- 115 Krishna block
Alluri Sitarama Raju academy of medical sciences malkapuram Eluru
Andra pradhesh 534005
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9398752811 |
| Fax |
|
| Email |
perantibandreddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Nirupama Bhagya Lakshmi Tatavarthi |
| Designation |
Professor and HOD MD DVL |
| Affiliation |
Department of DVL ASRAM Hospital |
| Address |
Room no 118 DEPARTMENT OF DVL 1st floor
ASRAM HOSPITAL MALKAPURAM ELURU
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9553164588 |
| Fax |
|
| Email |
niruluckee@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bandreddy Peranti |
| Designation |
Post graduate resident |
| Affiliation |
Alluri Sitarama Raju Academy of Medical Sciences |
| Address |
Room no- 115 Krishna block
Alluri Sitarama Raju academy of medical sciences malkapuram Eluru
Andra pradhesh 534005
West Godavari
ANDHRA PRADESH
534005
India |
| Phone |
9398752811 |
| Fax |
|
| Email |
perantibandreddy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Bandreddy Peranti |
| Address |
Room no- 115 Krishna block
Alluri Sita Rama Raju academy of medical sciences malkapuram Eluru,Andra pradhesh 534005 |
| Type of Sponsor |
Other [Self] |
|
|
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 Bandreddy Peranti |
ASRAM Hospital affiliated to Alluri Sitarama Raju Academy of Medical Sciences |
Room no 118 Department of DVL
Malkapuram Eluru Andhra pradhesh 534005
West Godavari
ANDHRA PRADESH |
9398752811
perantibandreddy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASRAMS BHR Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L814||Other melanin hyperpigmentation, (2) ICD-10 Condition: L818||Other specified disorders of pigmentation, (3) ICD-10 Condition: L818||Other specified disorders of pigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Topical Thiamidol |
Topical Thiamidol is applied once daily for 12 weeks Clinical assessment will be done after every session of the treatment at 4weeks 8 weeks 12 weeks using MODIFIED MELASMA AREA AND SEVERITY INDEX SCORING and it will be compared with the baseline score |
| Comparator Agent |
Triple combination therapy |
Topical Triple combination therapy is given once daily for 12 weeks. Clinical assessment will be done after every session of the treatment at 4weeks 8 weeks12 weeks using MODIFIED MELASMA AREA AND SEVERITY INDEX SCORING and it will be compared with the baseline score |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All females and males with Melasma aged above18 years
Patients who are not on any other treatment for Melasma for past 1 month and patients who are advised to stop treatment for 1month
Patients unresponsive to regular topical agents
|
|
| ExclusionCriteria |
| Details |
Allergy or sensitivity to Thiamidol
Active skin conditions or infections like eczema, dermatitis in the treatment area
Recent laser or light based therapies
Pregnancy and lactation |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
Modification(s)
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of topical Thiamidol compared to triple combination therapy in patients with Melasma. Reduction in mMASI score indicating improvement in melasma severity |
Clinical assessment was performed using the Modified Melasma Area and Severity Index mMASI at baseline 4 weeks 8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary outcomes included the evaluation of side effects and patient tolerance to each therapy
|
Clinical assessment was performed using the Modified Melasma Area and Severity Index mMASI at baseline 4 weeks 8 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The trial has not begun enrolling patients Melasma is a pigmentary disorder that affects middle aged women more commonly presents as hyperpigmented irregular macules patches on sun exposed areas like cheeks upper lip chin nasal bridge forehead and the neck It is a stubborn condition which is more prone to relapse It has a complex etiology like exposure to Ultraviolet radiations pregnancy oral contraceptive pills Hormone replacement therapy etc
Various studies used multiple treatment modalities including topically applied depigmenting agents like hydroquinone alone triple combination therapy cysteamine chemical peels glycolic acid and laser therapy with none of them showing satisfactory outcomes Thiamidol is now being identified as a new potent inhibitor of human tyrosinase enzyme
This study titled Efficacy of Topical Isobutylamido Thiazolyl Resorcinol Thiamidol Compared to Triple Combination Therapy in patients with Melasma over 18 months The study aims to compare the therapeutic efficacy and safety of topical Thiamidol with the conventional triple combination therapy in patients with melasma A total of 68 patients clinically diagnosed with melasma will be randomly divided into two groups Group A will be treated with topical Thiamidol
Group B will be treated with triple combination therapy
Clinical assessment will be done by using the Modified Melasma Area and Severity Index mMASI at baseline 4 weeks 8 weeks and 12 weeks Clinical photographs will be taken at each time point under standardized conditions Data will be analyzed using paired and unpaired t tests The primary outcome will be the change in mMASI score from baseline to 12 weeks which will indicate treatment efficacy The secondary outcomes will include the evaluation of side effects and patient tolerance to each therapy
|