Oral Glutathione As A Skin Whitening Agent

NCT04105504 | Completed Phase 1

• 1 other identifier: RCTGlutathione
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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®.

Conditions

Glutathione; Skin Whitening

Keywords

glutathione; whitening

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (6)

• Subjective Improvement at 4 weeks

  4 weeks

• Adverse events at 4 weeks

  4 weeks

• Subjective Improvement at 8 weeks

  8 weeks

• Adverse events at 8 weeks

  8 weeks

• Subjective Improvement at 12 weeks

  12 weeks

Study Arms (2)

Glutathione Group

EXPERIMENTAL

Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.

Drug: Glutathione

Placebo Group

PLACEBO COMPARATOR

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

Interventions

Glutathione DRUG

Oral glutathione capsule (500 mg), were taken once daily by the subjects.

Also known as: L-Gluthatione

Glutathione Group

Placebo oral tablet DRUG

Placebo oral capsule were taken once daily by the subjects.

Placebo Group

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr Irma Bernadette S Sitohang: lead

Study Sites (1)

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, 10430, Indonesia

Location

Related Publications (1)

• 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.

  PMID: 34840651 DERIVED

MeSH Terms

Interventions

Glutathione

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: 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

Study Record Dates

• First Submitted: August 8, 2019
• First Posted: September 26, 2019
• Study Start: April 8, 2018
• Primary Completion: June 6, 2018
• Study Completion: August 1, 2018
• Last Updated: September 26, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)