Oral Glutathione As A Skin Whitening Agent

Phase 1

Completed

Brief 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®.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo oral tablet	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.
Glutathione Group	Glutathione	Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Spot UV at 4 weeks	4 weeks	Total reduction (improvement) of spot UV
Change from Baseline Spot UV at 8 weeks	8 weeks	Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 4 weeks	4 weeks	Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 12 weeks	12 weeks	Improvement of skin tone
Change from Baseline Spot Polarization at 8 weeks	8 weeks	Total reduction (improvement) of spot polarization
Change from Baseline Skin Tone at 4 weeks	4 weeks	Improvement of skin tone
Change from Baseline Skin Tone at 8 weeks	8 weeks	Improvement of skin tone
Change from Baseline Spot UV at 12 weeks	12 weeks	Total reduction (improvement) of spot UV
Change from Baseline Spot Polarization at 12 weeks	12 weeks	Total reduction (improvement) of spot polarization

Secondary Outcome Measures

Name	Time	Method
Subjective Improvement at 4 weeks	4 weeks	Subjects were asked to grade the overall response using rating scale with a multiple-choice question: 1. minimal improvement 2. moderate improvement 3. good improvement 4. excellent improvement Note: The higher improvement represents a better outcome.
Adverse events at 4 weeks	4 weeks	Adverse events related to therapy
Subjective Improvement at 8 weeks	8 weeks	Subjects were asked to grade the overall response using rating scale with a multiple-choice question: 1. minimal improvement 2. moderate improvement 3. good improvement 4. excellent improvement Note: The higher improvement represents a better outcome.
Adverse events at 8 weeks	8 weeks	Adverse events related to therapy
Subjective Improvement at 12 weeks	12 weeks	Subjects were asked to grade the overall response using rating scale with a multiple-choice question: 1. minimal improvement 2. moderate improvement 3. good improvement 4. excellent improvement Note: The higher improvement represents a better outcome.
Adverse events at 12 weeks	12 weeks	Adverse events related to therapy

Locations (1): Faculty of Medicine, Universitas Indonesia
🇮🇩
Jakarta Pusat, Indonesia