Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, 10430, Indonesia
NCT Number: NCT04105504
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®.
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Notify Me30 year–55 year
Female
Interventional
Phase 1
Jakarta Pusat, 10430, Indonesia
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®.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral glutathione capsule (500 mg), were taken once daily by the subjects.
Other names: L-Gluthatione
Placebo oral capsule were taken once daily by the subjects.
Time frame: 4 weeks
Total reduction (improvement) of spot UV
Time frame: 4 weeks
Total reduction (improvement) of spot polarization
Time frame: 4 weeks
Improvement of skin tone
Time frame: 8 weeks
Total reduction (improvement) of spot UV
Time frame: 8 weeks
Total reduction (improvement) of spot polarization
Time frame: 8 weeks
Improvement of skin tone
Time frame: 12 weeks
Total reduction (improvement) of spot UV
Time frame: 12 weeks
Total reduction (improvement) of spot polarization
Time frame: 12 weeks
Improvement of skin tone
Time frame: 4 weeks
Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
Note: The higher improvement represents a better outcome.
Time frame: 4 weeks
Adverse events related to therapy
Time frame: 8 weeks
Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
Note: The higher improvement represents a better outcome.
Time frame: 8 weeks
Adverse events related to therapy
Time frame: 12 weeks
Subjects were asked to grade the overall response using rating scale with a multiple-choice question:
Note: The higher improvement represents a better outcome.
Time frame: 12 weeks
Adverse events related to therapy
Dr Irma Bernadette S Sitohang
Other
Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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