Role of Oral Glutathione in Skin Whitening - Tabular View

Tracking Information
First Received Date ^ICMJE	November 17, 2009
Last Updated Date	November 17, 2009
Start Date ^ICMJE	February 2009
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 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

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
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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	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 *
* 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
Enrollment ^ICMJE	60
Completion Date	June 2009
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
Gender	Both
Ages	18 Years to 25 Years
Accepts Healthy Volunteers
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Thailand

Administrative Information
NCT Number ^ICMJE	NCT01016080
Other Study ID Numbers ^ICMJE	COA840/2008
Has Data Monitoring Committee	No
Responsible Party	Pravit Asawanonda, Chulalongkorn University
Study Sponsor ^ICMJE	Chulalongkorn University
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Chulalongkorn University
Verification Date	November 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP