Oral Glutathione As A Skin Whitening Agent

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

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®.

Study Overview

• Status: Completed
• Conditions: Glutathione; Skin Whitening
• Intervention / Treatment: Drug: Glutathione; Drug: Placebo oral tablet

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®.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 1

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta Pusat, Indonesia, 10430
    • Faculty of Medicine, Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Dr Irma Bernadette S Sitohang

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 8, 2018
• Primary Completion (Actual): June 6, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: August 8, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 26, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: glutathione; whitening
• Other Study ID Numbers: RCTGlutathione

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No