Oral Glutathione As A Skin Whitening Agent

What Was Tested

The trial (phase 1) is built around Glutathione.

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.

It had two arms (groups): Glutathione Group (experimental) and Placebo Group (placebo comparator).

Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.

Subjects were randomised to receive Placebo capsules, which were identical in appearance and packaged in identical-looking containers with the Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 90 actual participants took part.

It was open to women only aged from 30 years up to 55 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Healthy subjects with skin type Fitzpatrick IV and V. Women aged from 30 to 55 years with an understanding of all the information given by a written consent form. Working indoor office jobs (for minimum 8 hours).

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: personal or family history of skin cancer, especially melanoma; consumption of any preparations containing glutathione within 1 month of enrollment; use of any topical skin brightening or whitening preparations within 1 month of enrollment.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Glutathione and who got the comparison, which limits bias.

The Glutathione group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Glutathione, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2018-04-08 with completion listed for 2018-06-06.

It ran at 1 site in Indonesia.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline Spot UV at 4 weeks (time frame: 4 weeks). Change from Baseline Spot Polarization at 4 weeks (time frame: 4 weeks). Change from Baseline Skin Tone at 4 weeks (time frame: 4 weeks).

It also tracked 6 secondary outcomes, for example Adverse events at 4 weeks, Adverse events at 8 weeks and Adverse events at 12 weeks.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Glutathione in 90 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glutathione compound page, all human trials.