NCT01846338UnknownNot Applicable
The Effect of「GTT-EGCG」on Acne Women
National Yang Ming Chiao Tung University1 site in 1 country80 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- acne lesion counts
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
- •Very severe acne(IGA score5)
Arms & Interventions
green tea extract EGCG
Experimental
experimental: green tea extract EGCG, 500mg , tid, 4 weeks
Intervention: green tea extract EGCG (Dietary Supplement)
cellulose
Placebo Comparator
Placebo Comparator: cellulose, 500 mg tid, 4 weeks
Intervention: green tea extract EGCG (Dietary Supplement)
Outcomes
Primary Outcomes
acne lesion counts
Time Frame: four weeks
Secondary Outcomes
- quality of life, SF-12(four weeks)
Investigators
Chung-Hua Hsu
Associated Professor
National Yang Ming Chiao Tung University
Study Sites (1)
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