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Study of effect of Oral Glutathione Capsule for skin Lightening in subjects with dark skin

An Open-Label, Single-Arm, Prospective Clinical Study to Evaluate Efficacy and Safety of Oral Glutathione capsule as a skin-lightening agent in Subjects with dark skin and Hyperpigmentation.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/11/047177
Enrollment
40
Registered
2022-11-10
Start date
Unknown
Completion date
Unknown
Last updated
2022-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L814- Other melanin hyperpigmentation

Interventions

Intervention1: Glutathione: Glutathione capsule 600 mg OD for 30 Days Control Intervention1: NA: NA

Sponsors

Gangwal Healthcare Pvt Ltd
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr Abhijit Munshi

Alchemy Clinical Research Services

drabhijit@alchemyclinical.in9822371703

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026