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Oral Glutathione As A Skin Whitening Agent

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04105504
Recruitment Status : Completed
First Posted : September 26, 2019
Last Update Posted : September 26, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Irma Bernadette S Sitohang, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

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®.

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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

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04105504


Locations
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Indonesia
Faculty of Medicine, Universitas Indonesia
Jakarta Pusat, Indonesia, 10430
Sponsors and Collaborators
Dr Irma Bernadette S Sitohang
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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    Key Record Dates
Last Update Posted: September 26, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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