The Effect of「GTT-EGCG」on Acne Women
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 3, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMay 3, 2013
May 1, 2013
8 months
May 1, 2013
May 2, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
acne lesion counts
four weeks
Secondary Outcomes (1)
quality of life, SF-12
four weeks
Study Arms (2)
green tea extract EGCG
EXPERIMENTALexperimental: green tea extract EGCG, 500mg , tid, 4 weeks
cellulose
PLACEBO COMPARATORPlacebo Comparator: cellulose, 500 mg tid, 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Female patient
- 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)
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Yang Ming Chiao Tung Universitylead
- Taipei City Hospitalcollaborator
Study Sites (1)
Taipei City Hospital
Taipei, Taiwan, 886, Taiwan
Related Publications (2)
Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
PMID: 18468736BACKGROUNDHsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.
PMID: 21649457BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor
Study Record Dates
First Submitted
May 1, 2013
First Posted
May 3, 2013
Study Start
October 1, 2012
Primary Completion
June 1, 2013
Study Completion
September 1, 2013
Last Updated
May 3, 2013
Record last verified: 2013-05