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Oral Glutathione As A Skin Whitening Agent

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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

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE September 26, 2019
Last Update Posted Date September 26, 2019
Actual Study Start Date  ICMJE April 8, 2018
Actual Primary Completion Date June 6, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • Change from Baseline Spot UV at 4 weeks [ Time Frame: 4 weeks ]
    Total reduction (improvement) of spot UV
  • Change from Baseline Spot Polarization at 4 weeks [ Time Frame: 4 weeks ]
    Total reduction (improvement) of spot polarization
  • Change from Baseline Skin Tone at 4 weeks [ Time Frame: 4 weeks ]
    Improvement of skin tone
  • Change from Baseline Spot UV at 8 weeks [ Time Frame: 8 weeks ]
    Total reduction (improvement) of spot UV
  • Change from Baseline Spot Polarization at 8 weeks [ Time Frame: 8 weeks ]
    Total reduction (improvement) of spot polarization
  • Change from Baseline Skin Tone at 8 weeks [ Time Frame: 8 weeks ]
    Improvement of skin tone
  • Change from Baseline Spot UV at 12 weeks [ Time Frame: 12 weeks ]
    Total reduction (improvement) of spot UV
  • Change from Baseline Spot Polarization at 12 weeks [ Time Frame: 12 weeks ]
    Total reduction (improvement) of spot polarization
  • Change from Baseline Skin Tone at 12 weeks [ Time Frame: 12 weeks ]
    Improvement of skin tone
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2019)
  • 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.
  • Adverse events at 4 weeks [ Time Frame: 4 weeks ]
    Adverse events related to therapy
  • 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.
  • Adverse events at 8 weeks [ Time Frame: 8 weeks ]
    Adverse events related to therapy
  • 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.
  • Adverse events at 12 weeks [ Time Frame: 12 weeks ]
    Adverse events related to therapy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Glutathione As A Skin Whitening Agent
Official Title  ICMJE Oral Glutathione As A Skin Whitening Agent: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial
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®.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Glutathione
  • Skin Whitening
Intervention  ICMJE
  • Drug: Glutathione
    Oral glutathione capsule (500 mg), were taken once daily by the subjects.
    Other Name: L-Gluthatione
  • Drug: Placebo oral tablet
    Placebo oral capsule were taken once daily by the subjects.
Study Arms  ICMJE
  • Experimental: Glutathione Group
    Subjects were randomised to receive Glutathione capsules. The capsules were taken once daily for 12 weeks and evaluated every 4 weeks.
    Intervention: Drug: Glutathione
  • 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.
    Intervention: Drug: Placebo oral tablet
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 24, 2019)
90
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1, 2018
Actual Primary Completion Date June 6, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04105504
Other Study ID Numbers  ICMJE RCTGlutathione
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr Irma Bernadette S Sitohang, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Study Sponsor  ICMJE Dr Irma Bernadette S Sitohang
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP