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Trial record 10 of 105 for:    egcg

The Effect of「GTT-EGCG」on Acne Women

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ClinicalTrials.gov Identifier: NCT01846338
Recruitment Status : Unknown
Verified May 2013 by Chung-Hua Hsu, National Yang Ming University.
Recruitment status was:  Enrolling by invitation
First Posted : May 3, 2013
Last Update Posted : May 3, 2013
Sponsor:
Collaborator:
Taipei City Hospital
Information provided by (Responsible Party):
Chung-Hua Hsu, National Yang Ming University

Tracking Information
First Submitted Date  ICMJE May 1, 2013
First Posted Date  ICMJE May 3, 2013
Last Update Posted Date May 3, 2013
Study Start Date  ICMJE October 2012
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
acne lesion counts [ Time Frame: four weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2013)
quality of life, SF-12 [ Time Frame: four weeks ]
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 The Effect of「GTT-EGCG」on Acne Women
Official Title  ICMJE The Effect of「GTT-EGCG」on Acne Women
Brief Summary The aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial.
Detailed Description change in acne lesions counts, hormone, quality of life
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Lesion Counts
Intervention  ICMJE Dietary Supplement: green tea extract EGCG
EGCG, 500mg, tid, 4 weeks
Study Arms  ICMJE
  • Experimental: green tea extract EGCG
    experimental: green tea extract EGCG, 500mg , tid, 4 weeks
    Intervention: Dietary Supplement: green tea extract EGCG
  • Placebo Comparator: cellulose
    Placebo Comparator: cellulose, 500 mg tid, 4 weeks
    Intervention: Dietary Supplement: green tea extract EGCG
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 2, 2013)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2013
Estimated Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female patient
  • 20 to 45 years of age
  • moderate or severe acne vulgaris as defined by the Investigator's Global Assessment (IGA; score of 3 or 4 on a scale from 0 to 5)

Exclusion Criteria:

  • Received systemic retinoid or hormone treatment in the previous 3 months.
  • Abnormal liver enzymes or kidney function tests (1.5 times higher than the upper normal limit)
  • abnormal blood chemistry
  • Pregnant or breast feeding women or the intention of becoming pregnant
  • Concurrent systemic illness
  • PCOS
  • Very severe acne(IGA score5)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01846338
Other Study ID Numbers  ICMJE TCHIRB1010505
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chung-Hua Hsu, National Yang Ming University
Study Sponsor  ICMJE National Yang Ming University
Collaborators  ICMJE Taipei City Hospital
Investigators  ICMJE Not Provided
PRS Account National Yang Ming University
Verification Date May 2013

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