Oral Glutathione As A Skin Whitening Agent

• ClinicalTrials.gov Identifier: NCT04105504
• Recruitment Status: Completed
• First Posted: September 26, 2019
• Last Update Posted: September 26, 2019
• Sponsor: Dr Irma Bernadette S Sitohang
• Information provided by (Responsible Party): Dr Irma Bernadette S Sitohang, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Study Description

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®.

Condition or disease	Intervention/treatment	Phase
Glutathione; Skin Whitening	Drug: Glutathione; Drug: Placebo oral tablet	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
• Actual Study Start Date: April 8, 2018
• Actual Primary Completion Date: June 6, 2018
• Actual Study Completion Date: August 1, 2018

Arms and Interventions

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

1. Change from Baseline Spot UV at 4 weeks [ Time Frame: 4 weeks ]
   Total reduction (improvement) of spot UV
2. Change from Baseline Spot Polarization at 4 weeks [ Time Frame: 4 weeks ]
   Total reduction (improvement) of spot polarization
3. Change from Baseline Skin Tone at 4 weeks [ Time Frame: 4 weeks ]
   Improvement of skin tone
4. Change from Baseline Spot UV at 8 weeks [ Time Frame: 8 weeks ]
   Total reduction (improvement) of spot UV
5. Change from Baseline Spot Polarization at 8 weeks [ Time Frame: 8 weeks ]
   Total reduction (improvement) of spot polarization
6. Change from Baseline Skin Tone at 8 weeks [ Time Frame: 8 weeks ]
   Improvement of skin tone
7. Change from Baseline Spot UV at 12 weeks [ Time Frame: 12 weeks ]
   Total reduction (improvement) of spot UV
8. Change from Baseline Spot Polarization at 12 weeks [ Time Frame: 12 weeks ]
   Total reduction (improvement) of spot polarization
9. Change from Baseline Skin Tone at 12 weeks [ Time Frame: 12 weeks ]
   Improvement of skin tone

Secondary Outcome Measures :

1. Subjective Improvement at 4 weeks [ Time Frame: 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.

2. Adverse events at 4 weeks [ Time Frame: 4 weeks ]
   Adverse events related to therapy
3. Subjective Improvement at 8 weeks [ Time Frame: 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.

4. Adverse events at 8 weeks [ Time Frame: 8 weeks ]
   Adverse events related to therapy
5. Subjective Improvement at 12 weeks [ Time Frame: 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.

6. Adverse events at 12 weeks [ Time Frame: 12 weeks ]
   Adverse events related to therapy

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 55 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

Indonesia

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, Indonesia, 10430

Sponsors and Collaborators

Dr Irma Bernadette S Sitohang

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Dr Irma Bernadette S Sitohang, Dr. dr. Irma Bernadette S. Sitohang, SpKK(K) - Head of Cosmetic Dermatology Division of Dermatology and Venereology Department of Faculty of Medicine Universitas Indonesia / Cipto Mangunkusumo Hospital, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
• ClinicalTrials.gov Identifier: NCT04105504
• Other Study ID Numbers: RCTGlutathione
• First Posted: September 26, 2019
• Last Update Posted: September 26, 2019
• Last Verified: September 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Dr Irma Bernadette S Sitohang, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto:

glutathione; whitening