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CTRI Number  CTRI/2024/11/076217 [Registered on: 04/11/2024] Trial Registered Prospectively
Last Modified On: 28/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparision of topical 5 percent Cysteamine cream and 4 percent Hydroquinone cream in melasma 
Scientific Title of Study   Comparative efficacy of topical 5 percent Cysteamine cream and 4 percent Hydroquinone cream in melasma 
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. Mala Bhalla 
Designation  Professor, Dermatology 
Affiliation  GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH 
Address  Government Medical College and Hospital, Chandigarh, India.

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121545  
Fax    
Email  malabhalla@yahoo.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr.Mala Bhalla 
Designation  Professor, Dermatology 
Affiliation  GOVERNMENT MEDICAL COLLEGE AND HOSPITALCHANDIGARH 
Address  Government Medical College and Hospital, Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121545  
Fax    
Email  malabhalla@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Oshin Madaan 
Designation  Junior Resident, Dermatology 
Affiliation  GOVERNMENT MEDICAL COLLEGE AND HOSPITAL CHANDIGARH 
Address  Government Medical College and Hospital, Chandigarh, India

Chandigarh
CHANDIGARH
160030
India 
Phone  8847295568  
Fax    
Email  oshinapril@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  government medical college and hospital chandigarh 
Address  government medical college and hospital chandigarh, chandigarh 160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Oshin Madaan  Government Medical College and Hospital Chandigarh  Room number 4302,Dermatology opd, Department of Dermatology, Venereology and Leprosy, Government Medical College, and Hospital, Sector-32, Chandigarh.
Chandigarh
CHANDIGARH 
8847295568

oshinapril@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE (GMCH,CHANDIGARH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L814||Other melanin hyperpigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  4% hydroquinone cream  Seventy- four patients will be included in the study after taking informed consent/ assent. They shall be randomly divided into two groups of thirty- seven each using a random table method. One group (Group A) will apply topical 5% cysteamine cream over melasma patches for 15-30 minutes at bedtime initially which will be gradually increased to overnight application based on the tolerance of patient and the other group (Group B) will have overnight application of topical 4 % hydroquinone cream at bedtime for the duration of 9 weeks. Each patient will be followed up at 3 weekly intervals (3, 6 ,9). Another follow up visit will be conducted at 4 weeks after completing the course of treatment.Assessment of improvement for efficacy of therapy will be done by dermoscopic evaluation and by calculating the mMASI score of the face at each visit (3, 6 and 9 weeks) and 4 weeks later after completion of treatment. 
Intervention  cysteamine 5% cream  Cysteamine, an aminothiol derived from the breakdown of coenzyme A, is synthesized in various cell types. It demonstrates antioxidant properties and plays a role in regulating melanin production. Cysteamine is a promising newer topical option for treating melasma .comparative efficacy of topical 5% cysteamine cream and 4% hydroquinone cream in melasma will be assessed by assessing the comparative reduction in the modified Melasma Area and Severity Index (mMASI).Seventy- four patients will be included in the study after taking informed consent/ assent. They shall be randomly divided into two groups of thirty- seven each using a random table method. One group (Group A) will apply topical 5% cysteamine cream over melasma patches for 15-30 minutes at bedtime initially which will be gradually increased to overnight application based on the tolerance of patient and the other group (Group B) will have overnight application of topical 4 % hydroquinone cream at bedtime for the duration of 9 weeks. Each patient will be followed up at 3 weekly intervals (3, 6 ,9). Another follow up visit will be conducted at 4 weeks after completing the course of treatment.Common and important adverse effects such as redness, dryness, itching, burning, irritation, and dyspigmentation as stated above in the review of literature shall be explained to the patients. To assess for adverse effects, patients will be provided with a check list of possible side effects at every visit. Adverse effects reported by participants will be categorized according to the Numerical Rating Scale (NRS) in which each adverse effect will be assigned a numerical score ranging from 0 to 10, with 0 representing no side effect and 10 representing an extremely severe side effect. Patients will be asked to choose the number that corresponds to the severity of their symptom. In case a patient experiences severe redness, irritation, or hyperpigmentation (Numerical Rating Scale 7 or more), they will be removed from the study and treated with the appropriate therapy for those adverse effects and started on alternative treatment for melasma. During treatment, they will be advised strict photoprotection by avoidance of sun exposure and physical protection as well as use of physical sunscreen whenever outdoors. They will be strictly cautioned against the use of any unprescribed topical agent, fairness cream, or any facial cosmetic procedure which may interfere with the therapeutic outcome. Assessment of improvement for efficacy of therapy will be done by dermoscopic evaluation and by calculating the mMASI score of the face at each visit (3, 6 and 9 weeks) and 4 weeks later after completion of treatment.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of 18-50 years of age with clinical diagnosis of facial melasma. 
 
ExclusionCriteria 
Details  1.Pregnant and lactating mothers.
2.Patients with any severe systemic illness requiring systemic treatment of more than 4 weeks.
3.Patients received any oral treatment or any procedural treatment for melasma in the preceding four weeks.
4.Patients with personal or familial history of depigmenting disorders like vitiligo.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Reduction in melasma severity assessed using the modified Melasma Area and Severity Index (mMASI) score.
2. Reduction in pigmentary lesions assessed through clinical photography and dermoscopic evaluation.
 
from baseline to 13 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Patient-reported outcomes: Evaluation of treatment satisfaction and improvement in melasma.
2. Adverse effects: Monitoring and categorization of adverse events related to each treatment using the Numerical Rating Scale (NRS).
 
from baseline to 13 weeks 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
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)   18/11/2024 
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="0"
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  

Seventy- four patients will be included in the study after taking informed consent/ assent. They shall be randomly divided into two groups of thirty- seven each using a random table method. One group (Group A) will apply topical 5% cysteamine cream over melasma patches for 15-30 minutes at bedtime initially which will be gradually increased to overnight application based on the tolerance of patient and the other group (Group B) will have overnight application of topical 4 % hydroquinone cream at bedtime for the duration of 9 weeks. Each patient will be followed up at 3 weekly intervals (3, 6 ,9). Another follow up visit will be conducted at 4 weeks after completing the course of treatment.

Common and important adverse effects such as redness, dryness, itching, burning, irritation, and dyspigmentation shall be explained to the patients. To assess for adverse effects, patients will be provided with a check list of possible side effects at every visit. Adverse effects reported by participants will be categorized according to the Numerical Rating Scale (NRS) in which each adverse effect will be assigned a numerical score ranging from 0 to 10, with 0 representing no side effect and 10 representing an extremely severe side effect. Patients will be asked to choose the number that corresponds to the severity of their symptom. In case a patient experiences severe redness, irritation, or hyperpigmentation (Numerical Rating Scale 7 or more), they will be removed from the study and treated with the appropriate therapy for those adverse effects and started on alternative treatment for melasma. During treatment, they will be advised strict photoprotection by avoidance of sun exposure and physical protection as well as use of physical sunscreen whenever outdoors. They will be strictly cautioned against the use of any unprescribed topical agent, fairness cream, or any facial cosmetic procedure which may interfere with the therapeutic outcome.

Assessment of improvement for efficacy of therapy will be done by dermoscopic evaluation and by calculating the mMASI score of the face at each visit (3, 6 and 9 weeks) and 4 weeks later after completion of treatment.

Primary outcome measures

1.     Reduction in melasma severity assessed using the modified Melasma Area and Severity Index (mMASI) score.

2.     Reduction in pigmentary lesions assessed through clinical photography and dermoscopic evaluation.

Secondary outcome measures

1.     Patient-reported outcomes: Evaluation of treatment satisfaction and improvement in melasma.

2.     Adverse effects: Monitoring and categorization of adverse events related to each treatment using the Numerical Rating Scale (NRS).

At the end of this study, means of mMasi score from both groups will be calculated separately and the mean of difference between both groups will be compared. The response of patients towards improvement will be graded as per their level of self-satisfaction at the end of study as:

§  Poor response rate= 0-25% reduction

§  Fair response rate= 25-50% reduction

§  Good response rate=50-75% reduction

§  Excellent response rate=75-100% reduction

Clinical as well as dermoscopic photographs will be taken and labelled by specific numbers for each patient before starting the treatment and at each follow up visit and 4 weeks later after completion of treatment.

 
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