Oral Glutathione As A Skin Whitening Agent

Dr Irma Bernadette S Sitohang

Status and phase: Completed; Phase 1

Conditions: Skin Whitening; Glutathione

Treatments: Drug: Placebo oral tablet; Drug: Glutathione

Study type: Interventional

Funder types: Other

Identifiers

NCT04105504

RCTGlutathione

Details and patient eligibility

About

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®.

Full 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®.

Enrollment: 90 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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
• Pigmentary disorders or any dermatoses, which may affect the measurement within the study areas
• A pregnant or breastfeeding mother
• Personal history of drug allergy or skin disorder due to side effects of oral therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Glutathione Group

Experimental group

Description:

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

Treatment:

Drug: Glutathione

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo oral tablet