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CTRI Number  CTRI/2026/02/103260 [Registered on: 06/02/2026] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [cosmetic]  
Study Design  Other 
Public Title of Study   A Study to Evaluate a Test Product for Treating Facial Melasma in Women. 
Scientific Title of Study   A Baseline-Controlled Clinical Study to Evaluate the Efficacy and Tolerability of a Test Product in Female Trial participants with Facial Melasma over 16 Weeks 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SKIN/CYMS/2025-01 Version: 1.0 Date: 14 Jan 2026  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  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  mukta.sachdev@msclinical.com  
 
Details of Contact Person
Scientific Query  
Name  Ritambhara 
Designation  Director-Business and operations 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  09080826918  
Fax    
Email  ritambhara@msclinical.com  
 
Details of Contact Person
Public Query  
Name  Sudhanthiran S 
Designation  manager- Techno commercial 
Affiliation  MS Clinical Research Pvt. Ltd 
Address  327/15, 1st Main Road, Cambridge Layout, Ulsoor

Bangalore
KARNATAKA
560008
India 
Phone  08040917253  
Fax    
Email  sudhan@msclinical.com  
 
Source of Monetary or Material Support  
CATALYSIS S.L., Avenida de la Madera, 5. Villaluenga de la Sagra (45520), Toledo, Spain 
 
Primary Sponsor  
Name  CATALYSIS S.L.,  
Address  Avenida de la Madera, 5. Villaluenga de la Sagra (45520), Toledo, Spain 
Type of Sponsor  Other [FMCG] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NA 
 
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  MS Clinical Research Pvt. Ltd, 327/15,1st Main Road, Cambridge Layout, Ulsoor
Bangalore
KARNATAKA 		 08040917253

mukta.sachdev@msclinical.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE INDEPENDENT ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  female volunteers with facial melasma 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Melanil Foam 100 ml  All participants will apply the test product twice daily (morning and evening) from Baseline to Week 12; At Week 12, approximately 50% will discontinue while the remaining participants will continue until Week 16. The test product will be applied evenly over the face with primary focus on melasma-affected areas. 
Comparator Agent  NIL  Not Applicable 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  1. Female participants aged 25 to 60 years at the time of screening.

2. Participants in general good health, as determined by medical history and dermatological examination.

3. Participants with clinically diagnosed mild to moderate facial melasma, as assessed by the investigator.

4. Participants with Fitzpatrick skin phototypes III to VI.

5. Participants who have not used topical or systemic depigmenting, skin-lightening, or irritating products on the face within 7 days prior to baseline.

6. Participants willing to discontinue use of other facial skincare products during the study, except the test product and permitted basic products as advised by the investigator.

7. Participants without active facial dermatological conditions (e.g., severe acne, wounds, infections) that could interfere with study assessments.

8. Participants willing to avoid facial cosmetic or dermatological procedures during the study period.

9. Participants willing to avoid excessive sun exposure and follow sun-protection advice throughout the study.

10. Participants willing and able to comply with study procedures and scheduled visits.

11. Participants who provide written informed consent and agree to photographic documentation for study purposes. 
 
ExclusionCriteria 
Details  1. Participants with severe melasma or other facial dermatological conditions that may interfere with study evaluations.

2. Participants who are pregnant, breastfeeding, or planning pregnancy during the study period.

3. Participants with a known hypersensitivity or allergy to any component of the test product.

4. Participants who have undergone facial cosmetic or skin-lightening procedures within 7 days prior to baseline.

5. Participants currently using or having recently used oral photosensitizing medications or phototherapy within 7 days prior to baseline.

Participants who have received systemic corticosteroids, immunosuppressive therapy, or antiepileptic drugs within the past 6 months.

6. Participants with photosensitivity disorders or chronic facial dermatoses.

7. Participants with occupational or unavoidable excessive sun exposure that cannot be adequately controlled during the study period.

8. Participants who have participated in another clinical trial involving an investigational product within 3 months prior to screening.

9. Participants with psychological, cognitive, or language limitations that may affect informed consent or study compliance.

10. Participants unable to undergo standardized photography or assessments as required by the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Change from baseline in melasma severity as assessed by the Investigator Global Assessment (IGA).

2. Change from baseline in melasma severity as assessed by the Modified Melasma Area and Severity Index (mMASI).

3. Change from baseline in facial pigmentation as assessed by instrumental and photographic evaluations. 		 Weeks 4, 8, 12, and 16. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change from baseline in participant-perceived improvement of melasma as assessed by the Participant Self-Assessment Questionnaire.

2. Change from baseline in melasma-related quality of life, as assessed by the Melasma Quality of Life (MelasQoL) questionnaire, where applicable, at scheduled visits.

3. Assessment of skin tolerability of the test product based on investigator evaluation of local skin reactions and participant self-assessment.

4. Incidence, severity, and relationship of adverse events reported during the study period. 		 Weeks 4, 8, 12, and 16. 
5. Assessment of maintenance of treatment effect following product discontinuation, evaluated by change in IGA, mMASI, and instrumental assessments between Week 12 and Week 16 in participants who discontinue the test product at Week 12.  week 16 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   16/02/2026 
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="4"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 is an interventional, baseline-controlled, single-center study to evaluate the efficacy and tolerability of a test product in female participants with facial melasma. Participants will be followed for approximately 17 weeks, including screening and washout, with six study visits. Assessments will be conducted at baseline and at Weeks 4, 8, 12, and 16. At Week 12, approximately 50% of participants will discontinue the test product while the remaining will continue until Week 16 to assess maintenance of effect. 
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