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®.
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®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
90
Oral glutathione capsule (500 mg), were taken once daily by the subjects.
Placebo oral capsule were taken once daily by the subjects.
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, Indonesia
Change from Baseline Spot UV at 4 weeks
Total reduction (improvement) of spot UV
Time frame: 4 weeks
Change from Baseline Spot Polarization at 4 weeks
Total reduction (improvement) of spot polarization
Time frame: 4 weeks
Change from Baseline Skin Tone at 4 weeks
Improvement of skin tone
Time frame: 4 weeks
Change from Baseline Spot UV at 8 weeks
Total reduction (improvement) of spot UV
Time frame: 8 weeks
Change from Baseline Spot Polarization at 8 weeks
Total reduction (improvement) of spot polarization
Time frame: 8 weeks
Change from Baseline Skin Tone at 8 weeks
Improvement of skin tone
Time frame: 8 weeks
Change from Baseline Spot UV at 12 weeks
Total reduction (improvement) of spot UV
Time frame: 12 weeks
Change from Baseline Spot Polarization at 12 weeks
Total reduction (improvement) of spot polarization
Time frame: 12 weeks
Change from Baseline Skin Tone at 12 weeks
Improvement of skin tone
Time frame: 12 weeks
Subjective Improvement at 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.
Time frame: 4 weeks
Adverse events at 4 weeks
Adverse events related to therapy
Time frame: 4 weeks
Subjective Improvement at 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.
Time frame: 8 weeks
Adverse events at 8 weeks
Adverse events related to therapy
Time frame: 8 weeks
Subjective Improvement at 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.
Time frame: 12 weeks
Adverse events at 12 weeks
Adverse events related to therapy
Time frame: 12 weeks
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