Health Condition 1: L811- Chloasma Health Condition 2: L814- Other melanin hyperpigmentation
Conditions
Interventions
Intervention1: Cysteamine 5% cream: Once daily (to be applied once daily for 30mins in the evening for 112 days)
Control Intervention1: Hydroquinone 4% cream: Once daily (to be applied once daily at b
Sponsors
Cutis Institute of Dermatology
Eligibility
Inclusion criteria
Inclusion criteria: Patients who meet following criteria will be randomized in the study- 1. Indian adult subjects aged 18 to 60 years 2. Healthy subjects (no infectious and evolutive pathology which could make the subject vulnerable and stop the study, no pathology which could interfere with the study, no symptom in the process of an exploratory check-up) 3. With healthy intact skin on the studied anatomic unit (free of eczema, wounds, inflammation) 4. Patients willing to provide informed consent
Exclusion criteria
Exclusion criteria: Patients who do not meet following criteria will be randomized in the study- 1. Being pregnant or breastfeeding or having stopped to breastfeed in the past three months. 2. Having refused to give consent by not signing the consent form. 3. Taking part in another study liable to interfere with this study. 4. Being insulin-dependent diabetic or non-insulin-dependent diabetic with a recent therapy (less than 6 months) 5. Having progressive asthma. 6. Being epileptic. 7. Having non-stabilized thyroid disease (requirement of a stabilized treatment for at least 6 months) 8. Having cutaneous hypersensitivity to study ingredients 9. Having a diagnosed or highly probable allergy to one or several compounds of cosmetic products. 10. Following a chronic medical treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticosteroid therapy, taken by general or local routes (the only medication permitted is paracetamol)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent improvement in MSI score and mMASI score as assessed by a certified dermatologist.Timepoint: At day 0, 14, 28, 56 and 112 compared to baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Percent reduction in melanin content of pigmentory spots (melasma) assessed through a spectrophotometer (mexameter) at day 0,14, 28, 56 and 112 compared to baseline. 2. Dermatological assessment score for cosmetic acceptability at day 0,14, 28, 56 and 112. 3. Subject questionnaire for change in quality of lifestyle related to melasma and number of events at day 0, 56 &112. 4. The incidences of treatment emergent adverse events (TEAEs), treatment related AEs and AEs/SAEs leading to study withdrawal.Timepoint: Day 0,14, 28, 56 and 112 | — |
Countries
India
Contacts
Public ContactDr Wani Imran Majid
Cutis Institute of Dermatology
Outcome results
None listed