Health Condition 1: L814- Other melanin hyperpigmentation
Conditions
Interventions
Intervention1: Test Product: A thin coat (3 drops) of Test
Product to be applied on full face, focusing on the
melasma area
Control Intervention1: Cysteamine 5%: A thin coat of cysteamine 5%, to be
Sponsors
La Roche-Posay Laboratoire Dermatologique
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare Test Product to Cysteamine 5% in terms of raw value of mMASI at M4Timepoint: Month 0, Month 1, Month 2, Month 3, Month 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. Timepoint: Month 0, Month 1, Month 2, Month 3, Month 4 | — |
Countries
India
Contacts
Public ContactDr Mukta Sachdev
MS Clinical Research Pvt Ltd
Outcome results
None listed