| 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
|
|
|
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
|
|
|
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. |