Clinical trial NCT04105504: Oral Glutathione As A Skin Whitening Agent
Official title: Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glutathione
Skin Whitening
Keywords: glutathione
whitening
Lead sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Sponsor class: OTHER
First posted: 2019-09-26
Enrollment: 90
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

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

Primary outcomes:
measure: Change from Baseline Spot UV at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline Spot Polarization at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline Skin Tone at 4 weeks
timeFrame: 4 weeks
measure: Change from Baseline Spot UV at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Spot Polarization at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Skin Tone at 8 weeks
timeFrame: 8 weeks
measure: Change from Baseline Spot UV at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline Spot Polarization at 12 weeks
timeFrame: 12 weeks
measure: Change from Baseline Skin Tone at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Subjective Improvement at 4 weeks
timeFrame: 4 weeks
measure: Adverse events at 4 weeks
timeFrame: 4 weeks
measure: Subjective Improvement at 8 weeks
timeFrame: 8 weeks
measure: Adverse events at 8 weeks
timeFrame: 8 weeks
measure: Subjective Improvement at 12 weeks
timeFrame: 12 weeks
measure: Adverse events at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jakarta Pusat
country: Indonesia
facility: Faculty of Medicine, Universitas Indonesia
Study officials:
References:
citation: Sitohang IBS, Anwar AI, Jusuf NK, Arimuko A, Norawati L, Veronica S. Evaluating Oral Glutathione Plus Ascorbic Acid, Alpha-lipoic Acid, and Zinc Aspartate as a Skin-lightening Agent: An Indonesian Multicenter, Randomized, Controlled Trial. J Clin Aesthet Dermatol. 2021 Jul;14(7):E53-E58. Epub 2021 Jul 1.