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Completed

NCT Number: NCT04105504

Oral Glutathione As A Skin Whitening Agent

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®.

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Key information

Age range

30 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Faculty of Medicine, Universitas Indonesia

Jakarta Pusat, 10430, Indonesia

About this study

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®.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glutathione

Drug

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

Other names: L-Gluthatione

Placebo oral tablet

Drug

Placebo oral capsule were taken once daily by the subjects.

Primary outcomes

  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 outcomes

  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:

    • minimal improvement
    • moderate improvement
    • good improvement
    • 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:

    • minimal improvement
    • moderate improvement
    • good improvement
    • 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:

    • minimal improvement
    • moderate improvement
    • good improvement
    • 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

Sponsors and collaborators

Lead sponsor

Dr Irma Bernadette S Sitohang

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 26, 2019
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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