Health Condition 1: L814- Other melanin hyperpigmentation
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy Volunteers, men or women, from 18 to 60 years old. 2. Having given their written, free and informed consent. 3. Healthy subjects with skin type Fitzpatrick IV and V. 4. Working indoor office jobs (for minimum 8 hours).
Exclusion criteria
Exclusion criteria: 1. Personal or family history of skin cancer, especially melanoma. 2. Consumption of any preparations containing glutathione within 1 month of enrolment. 3. Use of any topical skin brightening or whitening preparations within 1 month of enrolment. 4. Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas. 5. A pregnant or breastfeeding mother. 6. Personal history of drug allergy or skin disorder due to side effects of oral therapy. 7. Alcoholics and subjects with substance abuse. 8. Subjects who have participated in other trial within last 3 months. 9. Any other condition which the principal investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects with Skin lightening over baseline at least one tone light at 30 days of treatment using Fitzpatrick scale the from baseline visit to end of treatment visit.Timepoint: Day 1 to Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in Liver function testTimepoint: Day 1 to Day 30;Mean change in Melanin indicesTimepoint: Day 1 to Day 30;Mean change in Plasma Glutathione levelTimepoint: Day 1 to Day 30;Overall improvement in Skin tone by Patientâ??s Global AssessmentTimepoint: Day 1 to Day 30;Overall improvement in Skin tone by Physicianâ??s Global AssessmentTimepoint: Day 1 to Day 30;The numbers of subjects with Decreased Melanin IndexTimepoint: Day 1 to Day 30 | — |
Countries
India
Contacts
Alchemy Clinical Research Services