Study of effect of Oral Glutathione Capsule for skin Lightening in subjects with dark ski
- Conditions
- Health Condition 1: L814- Other melanin hyperpigmentation
- Registration Number
- CTRI/2022/11/047177
- Lead Sponsor
- Gangwal Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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