Oral Glutathione As A Skin Whitening Agent

Study Overview
=================
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®.

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

Conditions
-----------------
Glutathione, Skin Whitening

Intervention / Treatment
-----------------
* Drug: Glutathione
* Drug: Placebo oral tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Glutathione Group<br>Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks. | Drug: Glutathione<br>* Oral glutathione capsule (500 mg), were taken once daily by the subjects.<br>* Other names: L-Gluthatione;|
| Placebo Comparator: Placebo Group<br>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. | Drug: Placebo oral tablet<br>* Placebo oral capsule were taken once daily by the subjects.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Spot UV at 4 weeks | Total reduction (improvement) of spot UV | 4 weeks | 
| Change from Baseline Spot Polarization at 4 weeks | Total reduction (improvement) of spot polarization | 4 weeks | 
| Change from Baseline Skin Tone at 4 weeks | Improvement of skin tone | 4 weeks | 
| Change from Baseline Spot UV at 8 weeks | Total reduction (improvement) of spot UV | 8 weeks | 
| Change from Baseline Spot Polarization at 8 weeks | Total reduction (improvement) of spot polarization | 8 weeks | 
| Change from Baseline Skin Tone at 8 weeks | Improvement of skin tone | 8 weeks | 
| Change from Baseline Spot UV at 12 weeks | Total reduction (improvement) of spot UV | 12 weeks | 
| Change from Baseline Spot Polarization at 12 weeks | Total reduction (improvement) of spot polarization | 12 weeks | 
| Change from Baseline Skin Tone at 12 weeks | Improvement of skin tone | 12 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glutathione, whitening