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CTRI Number  CTRI/2024/04/066500 [Registered on: 29/04/2024] Trial Registered Prospectively
Last Modified On: 26/04/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study on patients suffering from Melasma (a skin problem caused by brown to gray-brown patches on the face) to determine efficacy and safety of 2 skin care products which are Cysteamine cream with Hydroquinone cream. 
Scientific Title of Study   A prospective, randomized, comparative open label study to evaluate efficacy and safety of Cysteamine 5% cream with Hydroquinone 4 % cream in patients with Melasma.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IIS/2024/01,version 1.0 dated 23-Jan-2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Wani Imran Majid 
Designation  Director  
Affiliation  Cutis Institute of Dermatology 
Address  Department of Dermatology, Hyderpora Srinagar 190014 Jammu Kashmir

Srinagar
JAMMU & KASHMIR
190014
India 
Phone  7006971891  
Fax    
Email  drimranmajid@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Wani Imran Majid 
Designation  Director  
Affiliation  Cutis Institute of Dermatology 
Address  Department of Dermatology, Hyderpora Srinagar 190014 Jammu Kashmir

Srinagar
JAMMU & KASHMIR
190014
India 
Phone  7006971891  
Fax    
Email  drimranmajid@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Wani Imran Majid 
Designation  Director  
Affiliation  Cutis Institute of Dermatology 
Address  Department of Dermatology, Hyderpora Srinagar 190014 Jammu Kashmir

Srinagar
JAMMU & KASHMIR
190014
India 
Phone  7006971891  
Fax    
Email  drimranmajid@gmail.com  
 
Source of Monetary or Material Support  
Glenmark Pharmaceuticals Ltd. Mumbai- 400099 
 
Primary Sponsor  
Name  Cutis Institute of Dermatology 
Address  Cutis Institute of Dermatology Hyderpora Srinagar19 0014 Jammu Kashmir 
Type of Sponsor  Private hospital/clinic 
 
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 Wani Imran Majid  Cutis Institute of Dermatology  Department of Dermatology,Hyderpora Srinagar 190014 Jammu Kashmir
Srinagar
JAMMU & KASHMIR 
7006971891

drimranmajid@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
lslamic University of Science and Technology  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma, (2) ICD-10 Condition: L814||Other melanin hyperpigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cysteamine 5% cream  Once daily (to be applied once daily for 30mins in the evening for 112 days) 
Comparator Agent  Hydroquinone 4% cream  Once daily (to be applied once daily at bedtime for 112 days) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients who meet following criteria will be randomized in the study-
1. Indian adult subjects aged 18 to 60 years
2. Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up)
3. With healthy intact skin on the studied anatomic unit (free of eczema, wounds, inflammation)
4. Patients willing to provide informed consent
 
 
ExclusionCriteria 
Details  Patients who do not meet following criteria will be randomized in the study-
1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months.
2. Having refused to give consent by not signing the consent form.
3. Taking part in another study liable to interfere with this study.
4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months)
5. Having progressive asthma.
6. Being epileptic.
7. Having non-stabilized thyroid disease (requirement of a stabilized treatment for at least 6 months)
8. Having cutaneous hypersensitivity to study ingredients
9. Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products.
10. Following a chronic medical treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percent improvement in MSI score and mMASI score as assessed by a certified dermatologist.   At day 0, 14, 28, 56 and 112 compared to baseline 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percent reduction in melanin content of pigmentory spots (melasma) assessed through a spectrophotometer (mexameter) at day 0,14, 28, 56 and 112 compared to baseline.
2. Dermatological assessment score for cosmetic acceptability at day 0,14, 28, 56 and 112.
3. Subject questionnaire for change in quality of lifestyle related to melasma and number of events at day 0, 56 &112.
4. The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal. 
Day 0,14, 28, 56 and 112 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 4 
Date of First Enrollment (India)   09/05/2024 
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)  Closed to Recruitment of Participants 
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  

This prospective, randomized, comparative, open label study is to compare efficacy, safety and tolerability of Cysteamine 5% cream with Hydroquinone 4% cream in melasma patients. After obtaining written informed consent, patients will be screened and eligible patients with melasma will be randomized into either Cysteamine 5% cream arm or Hydroquinone 4% cream arm. Study drug will be applied for 30 min for 112 days and comparator will be applied at bedtime.

Efficacy evaluations (MSI score, mMASI score) will be done at baseline, Day 14, Day 28, Day 56 and Day 112.

Safety will be assessed for any adverse or serious adverse events, patient reported symptoms and recorded by the treating physician and also if the physician deemed the event to be related to either study drug or comparator. Mexametry to determine melanin content of the skin will be done at Baseline, Day 56 and Day 112. Dermatological assessment for skin tolerability will be done in all visits along with MASI ,mMASI score will be determined at all visits. Quality of Life questionnaire to determine change in quality of lifestyle related to melasma and number of events will be obtained from patients at baseline, Day 56 and Day 112.

In the maintenance phase, patient will be followed up every two weeks telephonically up to 12 weeks or time of relapse, whichever is earlier. Patient complaining of relapse will be asked for physical examination at the site.

 

 
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