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Trial record 1 of 1 for:    glutathione skin whitening
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Role of Oral Glutathione in Skin Whitening

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ClinicalTrials.gov Identifier: NCT01016080
Recruitment Status : Completed
First Posted : November 18, 2009
Last Update Posted : November 18, 2009
Sponsor:
Information provided by:
Chulalongkorn University

Tracking Information
First Submitted Date  ICMJE November 17, 2009
First Posted Date  ICMJE November 18, 2009
Last Update Posted Date November 18, 2009
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2009)
Skin melanin index [ Time Frame: 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Oral Glutathione in Skin Whitening
Official Title  ICMJE Glutathione as an Oral Whitening Agent: a Randomized, Double-blind, Placebo-controlled Study
Brief Summary Oral and intravenous glutathione have been used widely to whiten the skin. The investigators tested this hypothesis by giving oral glutathione for 4 weeks to medical students.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Skin Whitening
Intervention  ICMJE
  • Drug: glutathione
    250 mg capsules, twice daily, orally
  • Drug: placebo
    250 mg capsules, twice daily, orally
Study Arms  ICMJE
  • Active Comparator: oral glutathione
    glutathione, 500 mg, taken orally twice daily
    Intervention: Drug: glutathione
  • Placebo Comparator: placebo capsules
    identical-appearing placebo capsules
    Intervention: Drug: placebo
Publications * Not Provided

*   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: November 17, 2009)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy medical students

Exclusion Criteria:

  • history of skin cancer, especially melanoma
  • consumption of any preparations containing glutathione within 1 month of enrollment
  • pigmentary disorders or any dermatoses
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 25 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01016080
Other Study ID Numbers  ICMJE COA840/2008
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pravit Asawanonda, Chulalongkorn University
Study Sponsor  ICMJE Chulalongkorn University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chulalongkorn University
Verification Date November 2009

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