Oral Glutathione As A Skin Whitening Agent

NCT ID: NCT04105504

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-08
• Study Completion Date: 2018-08-01

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®.

Conditions

Glutathione; Skin Whitening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Glutathione Group

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

Group Type: EXPERIMENTAL

Glutathione

Intervention Type: DRUG

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

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.

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

Placebo oral capsule were taken once daily by the subjects.

Interventions

Glutathione

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

Intervention Type: DRUG

Placebo oral tablet

Placebo oral capsule were taken once daily by the subjects.

Intervention Type: DRUG

Other Intervention Names

L-Gluthatione

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr Irma Bernadette S Sitohang

OTHER

Sponsor Role: lead

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

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, , Indonesia

Countries

Indonesia

References

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.

Reference Type: DERIVED

PMID: 34840651 (View on PubMed)

Other Identifiers

RCTGlutathione

Identifier Type: -

Identifier Source: org_study_id