NCT04105504

Oral Glutathione As A Skin Whitening Agent

Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Dr Irma Bernadette S Sitohang · Academic / Other
• Sex: Female
• Age: 30 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules or placebo for 12 weeks and evaluated every 4 weeks. The main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.

Detailed description

The objective of the study was to evaluate the efficacy and safety of oral glutathione for 12 weeks, used as a skin-whitening agent. The study was a randomized, double-blind, placebo-controlled, multicenter study, set at Dermatology outpatient clinic at three different hospitals in Indonesia, Gatot Seobroto Army Hospital Jakarta, Dr. dr. Wahiddin Soedirohoesodo Hospital Makassar, and University of Sumatera Utara Teaching Hospital Medan. Ninety healthy females, aged between 33 and 50 years, were randomized to receive either glutathione capsules (500 mg) or placebo capsules, which were identical in appearance and packaged in identical-looking containers. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. Compliance was assessed by counting the remaining capsules at each follow-up visit. At each follow-up visit, subjects were asked to grade the overall response and questioned regarding adverse events. The objective or main outcome was total reduction (improvement) of spot UV, spot polarization, and skin tone measured at five different sites for each indices, recorded by Janus Facial Analysis System®.

Conditions

• Glutathione
• Skin Whitening

Interventions

Type	Name	Description
DRUG	Glutathione	Oral glutathione capsule (500 mg), were taken once daily by the subjects.
DRUG	Placebo oral tablet	Placebo oral capsule were taken once daily by the subjects.

Timeline

• Start date: 2018-04-08
• Primary completion: 2018-06-06
• Completion: 2018-08-01
• First posted: 2019-09-26
• Last updated: 2019-09-26

Locations

1 site across 1 country: Indonesia