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

Recruiting

• Conditions: Other melanin hyperpigmentation,

• Registration Number: CTRI/2022/11/047177
• Lead Sponsor: Gangwal Healthcare Pvt Ltd

Brief Summary

The study is designed as Open label, singlearm, prospective, interventional and observational study. All the subjects willreceive Glutathione capsule 600 mg as a test product. Subjects fulfilling theinclusion and exclusion criteria will be enrolled in the study. Enrolledsubjects will be under treatment for 4 weeks, following up at day 15 and day30.

Parameters of Skin tone and Melaninindices and quality of life questionnaires will be assessed at baseline and atday 30. Safety parameters like hematology and biochemistry will be assessed atbaseline and at day 30.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-10-11
• Study Start: 2022-11-14

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1.Healthy Volunteers, men or women, from 18 to 60 years old.
• 2.Having given their written, free and informed consent.
• 4.Working indoor office jobs (for minimum 8 hours).

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.

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.	Day 1 to Day 30

Secondary Outcome Measures

Name	Time	Method
The numbers of subjects with Decreased Melanin Index	Day 1 to Day 30
Mean change in Liver function test	Day 1 to Day 30
Mean change in Melanin indices	Day 1 to Day 30
Mean change in Plasma Glutathione level	Day 1 to Day 30
Overall improvement in Skin tone by Physician’s Global Assessment	Day 1 to Day 30
Overall improvement in Skin tone by Patient’s Global Assessment	Day 1 to Day 30

Trial Locations

Locations (1)

KR Hospital; 🇮🇳 Mysore, KARNATAKA, India

KR Hospital

🇮🇳Mysore, KARNATAKA, India

Dr Bangaru H

Principal investigator

8971832402

drbangaruskin@gmail.com