| CTRI Number |
CTRI/2023/10/058259 [Registered on: 04/10/2023] Trial Registered Prospectively |
| Last Modified On: |
15/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study of Test Product and Cysteamine 5% in Treating Facial Epidermal Melasma |
|
Scientific Title of Study
|
Randomized controlled investigator blinded comparative study of the efficacy and tolerability of Test Product
versus Cysteamine 5% cream in the treatment of facial epidermal melasma over 4 months |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| SKIN/LPMS/2023-01, ver 1.0, dated 30 Aug 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukta Sachdev |
| Designation |
Principal Investigator |
| Affiliation |
MS Clinical Research Pvt Ltd |
| Address |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
KARNATAKA
560008
India |
| Phone |
08041125934 |
| Fax |
|
| Email |
mukta.sachdev@msclinical.com |
|
|
Source of Monetary or Material Support
|
| La Roche-Posay Laboratoire Dermatologique |
|
|
Primary Sponsor
|
| Name |
La Roche-Posay Laboratoire Dermatologique |
| Address |
62 Quai Charles Pasqua
92300 LEVALLOIS PERRET
|
| Type of Sponsor |
Other [FMCG (Fast moving Consumer Goods)] |
|
|
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 Mukta Sachdev |
MS Clinical Research Pvt Ltd |
Second floor, Evaluation room no. 1, 327/15, 1st Main Road, Cambridge layout, Ulsoor, Bangalore.
Bangalore
KARNATAKA |
08041125934
mukta.sachdev@msclinical.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| CLINICOM Ethics Committee |
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 |
| Intervention |
Test Product |
A thin coat (3 drops) of Test
Product to be applied on full face, focusing on the
melasma area |
| Comparator Agent |
Cysteamine 5% |
A thin coat of cysteamine 5%, to be applied on full face, focusing on the melasma area |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects in general good health as determined from a recent medical history, general physical examination, dermatological assessment.
2. Subjects of Phototype III, IV, V,
3. Subjects diagnosed with facial epidermal Melasma (exclude mixed and dermal melasma) for more than 1 year.
4. Subjects who have not used contraindicated products (irritants, other depigmenting agents) in the past 4-24 weeks (as per the treatment category, as per dermatologists’ discretion,
5. Subjects willing to stop all other skin care products and diligently follow the provided treatment plan.
6. Subject free of excessive hair, acne, cuts, abrasions, fissures, wounds,lacerations, or any other active skin conditions on the face,
7. Subject who agrees not to use any other product/treatment/home remedy/except the provided products on their face during the study period other than the test product,
8. Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period,
9. Subjects who agree not to expose to excessive sun light. (Sun exposure not more than half an hour daily and during that time use of umbrella to cover face),
10.Subjects willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up,
11. Subjects willing to abide by and comply with the study protocol |
|
| ExclusionCriteria |
| Details |
1. Subject with any other signs of significant local irritation or skin disease,
2. Subjects diagnosed with Mixed and Dermal melasma (wood lamp at inclusion),
3. Subjects using oral contraceptive pills or hormonal implants as birth control measures during the study,
4. Subjects on hormonal therapy (contraceptive, TSH) for at least 6 months,
5. Subjects who are pregnant, breastfeeding or have any plans of pregnancy,
6. Subjects planning a pregnancy 4 months after the end of the study period,
7. Patient applying irritants (2 weeks wash out),
8. Subjects who recently had a skin lightening skin procedure in the past 8 weeks,
9. Subjects using corticosteroids.
10. Subjects who have been taking antiepileptic medications for the previous six months,
11.Subjects with a history of any other dermatosis of the face or known photosensitivity,
12.Subject who is undergoing topical treatment with Sun Protection Factor in past 1 month,
13.Subject having any facial procedure planned during the course of the study,
14.Patient who underwent phototherapy in past 1 month wash out,
15.Subjects with any other active skin condition that may interfere with the study results,
16.Subjects with a known history of allergenic reaction to any components of the products,
17.Subjects who have participated in any other clinical trial in the last 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare Test Product to Cysteamine 5% in terms of
raw value of mMASI at M4 |
Month 0, Month 1, Month 2, Month 3, Month 4 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare TP to CYS at each evaluation time:
1. mMASI, in terms of raw value (other than M4) and %
change from Baseline
2.Investigator Global Assessment (IGA), in terms of proportion of subjects across the IGA scores (0 to 3).
3.Skin Hydration, in terms of proportion of subjects across
the scores (1 to 5)
4.Evenness of Skin tone, in terms of proportion of subjects across the scores.
5.Subject Self-Assessment Questionnaire (VAS 0 to 5), in
terms of raw value for each question
6.Satisfaction questionnaire, in terms of proportion of subjects across the categories for each question.
|
Month 0, Month 1, Month 2, Month 3, Month 4 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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 2 |
|
Date of First Enrollment (India)
|
03/09/2024 |
| 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="0"
Months="5"
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
|
This study is to compare the efficacy and tolerability of a new
depigmenting cosmetic formulation versus Cysteamine 5% in the acute management
of melasma over 4 months. The study will be conducted for a period of approximately 4 months for each subject
and will include a total of 6 visits. A total of 140 subjects will be
enrolled and 120 subjects are expected to complete the study. Various assessment Digital Imaging VISIACR®→ Dermatological Examination → Spectrophotometer® reading→ subject self-assessment will be done for the entire study duration for comparing the two groups.. |