| 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
|
|
|
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
|
|
|
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
|
|
|
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. |