None listed
Conditions
Interventions
Intervention1: 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-affecte
Sponsors
CATALYSIS S.L.,
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Weeks 4, 8, 12, and 16. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: 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.Timepoint: week 16 | — |
Countries
India
Contacts
Public ContactSudhanthiran S
MS Clinical Research Pvt. Ltd
Outcome results
None listed