Irma Bernadette S Sitohang1,2,3,4,5,6, Anis Irawan Anwar1,2,3,4,5,6, Nelva K Jusuf1,2,3,4,5,6, Abraham Arimuko1,2,3,4,5,6, Lilik Norawati1,2,3,4,5,6, Silvia Veronica1,2,3,4,5,6. 1. Dr. Sitohang is with the Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Indonesia. 2. Dr. Cipto Mangunkusumo Hospital in Jakarta, Indonesia. 3. Dr. Anwar is with the Department of Dermatology and Venereology, Faculty of Medicine Universitas Hasanuddin. 4. Dr. Wahidin Sudirohusodo Hospital in Makassar, Indonesia. 5. Dr. Jusuf is with the Division of Cosmetic Dermatology, Department of Dermatology and Venereology, Faculty of Medicine, Universitas Sumatera Utara-Universitas Sumatera Utara Hospital in Medan, Indonesia. 6. Drs. Arimuko, Norawati, and Veronica are with the Department of Dermatology and Venereology, Presidential-Army Central Hospital Gatot Soebroto in Jakarta, Indonesia.
Abstract
CLINICALTRIALSGOV IDENTIFIER: NCT04105504. BACKGROUND: For Asians, especially women with darker skin tones (Fitzpatrick Skin Types IV and V), clear, bright skin is considered highly desirable, and various topical, oral, or injection-based cosmetic skin-lightening agents with different mechanisms of action are widely available across Asia. OBJECTIVE: We sought to investigate the efficacy and safety of an oral glutathione supplement comprising L-glutathione (fermentation), ascorbic acid, alpha-lipoic acid, and zinc (as zinc aspartate) as a skin-lightening agent. METHODS: This randomized, double-blind, controlled clinical trial was carried out at three teaching hospital-based dermatovenereology clinics in Indonesia. Participants were randomized to receive either the glutathione supplement or placebo capsules and were evaluated every four weeks over a 12-week study period. Total reduction in spot ultraviolet, spot polarization, and skin tone were measured and recorded using a Janus Facial Analysis System® (PIE Co., Ltd, Suwon-si, Gyeonggi-do, Korea). RESULTS: Eighty-three participants, aged between 33 and 50 years, completed the study. Reductions in spot ultraviolet in certain subgroups, spot polarization, and skin tone were greater in the glutathione supplement group than in the placebo group, but the difference was not statistically significant. Both the glutathione supplement and placebo groups experienced only mild side effects in the first four weeks. CONCLUSION: The oral glutathione supplement was slightly beneficial for skin lightening in particular subgroups, but the results were not statistically significant. Mild and temporary side effects were reported. Further research is required to more fully evaluate the efficacy of this glutathione supplement as a skin-lightening agent.
CLINICALTRIALSGOV IDENTIFIER: NCT04105504. BACKGROUND: For Asians, especially women with darker skin tones (Fitzpatrick Skin Types IV and V), clear, bright skin is considered highly desirable, and various topical, oral, or injection-based cosmetic skin-lightening agents with different mechanisms of action are widely available across Asia. OBJECTIVE: We sought to investigate the efficacy and safety of an oral glutathione supplement comprising L-glutathione (fermentation), ascorbic acid, alpha-lipoic acid, and zinc (as zinc aspartate) as a skin-lightening agent. METHODS: This randomized, double-blind, controlled clinical trial was carried out at three teaching hospital-based dermatovenereology clinics in Indonesia. Participants were randomized to receive either the glutathione supplement or placebo capsules and were evaluated every four weeks over a 12-week study period. Total reduction in spot ultraviolet, spot polarization, and skin tone were measured and recorded using a Janus Facial Analysis System® (PIE Co., Ltd, Suwon-si, Gyeonggi-do, Korea). RESULTS: Eighty-three participants, aged between 33 and 50 years, completed the study. Reductions in spot ultraviolet in certain subgroups, spot polarization, and skin tone were greater in the glutathione supplement group than in the placebo group, but the difference was not statistically significant. Both the glutathione supplement and placebo groups experienced only mild side effects in the first four weeks. CONCLUSION: The oral glutathione supplement was slightly beneficial for skin lightening in particular subgroups, but the results were not statistically significant. Mild and temporary side effects were reported. Further research is required to more fully evaluate the efficacy of this glutathione supplement as a skin-lightening agent.