Oral Glutathione As A Skin Whitening Agent

Skin Whitening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04105504
• Other study ID #: RCTGlutathione
• Status: Completed
• Phase: Phase 1
• Start date: April 8, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: September 2019
• Source: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 1, 2018
• Est. primary completion date: June 6, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Glutathione
• Skin Whitening

Intervention

Drug:
• Glutathione
Oral glutathione capsule (500 mg), were taken once daily by the subjects.
• Placebo oral tablet
Placebo oral capsule were taken once daily by the subjects.

Locations

Country	Name	City	State
Indonesia	Faculty of Medicine, Universitas Indonesia	Jakarta Pusat

Sponsors (1)

Lead Sponsor	Collaborator
Dr Irma Bernadette S Sitohang

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Spot UV at 4 weeks	Total reduction (improvement) of spot UV	4 weeks
Primary	Change from Baseline Spot Polarization at 4 weeks	Total reduction (improvement) of spot polarization	4 weeks
Primary	Change from Baseline Skin Tone at 4 weeks	Improvement of skin tone	4 weeks
Primary	Change from Baseline Spot UV at 8 weeks	Total reduction (improvement) of spot UV	8 weeks
Primary	Change from Baseline Spot Polarization at 8 weeks	Total reduction (improvement) of spot polarization	8 weeks
Primary	Change from Baseline Skin Tone at 8 weeks	Improvement of skin tone	8 weeks
Primary	Change from Baseline Spot UV at 12 weeks	Total reduction (improvement) of spot UV	12 weeks
Primary	Change from Baseline Spot Polarization at 12 weeks	Total reduction (improvement) of spot polarization	12 weeks
Primary	Change from Baseline Skin Tone at 12 weeks	Improvement of skin tone	12 weeks
Secondary	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
Secondary	Adverse events at 4 weeks	Adverse events related to therapy	4 weeks
Secondary	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
Secondary	Adverse events at 8 weeks	Adverse events related to therapy	8 weeks
Secondary	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
Secondary	Adverse events at 12 weeks	Adverse events related to therapy	12 weeks