The Effect of「GTT-EGCG」on Acne Women

NCT ID: NCT01846338

Last Updated: 2013-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-09-30

Brief Summary

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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

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change in acne lesions counts, hormone, quality of life

Conditions

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Acne Lesion Counts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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green tea extract EGCG

experimental: green tea extract EGCG, 500mg , tid, 4 weeks

Group Type EXPERIMENTAL

green tea extract EGCG

Intervention Type DIETARY_SUPPLEMENT

EGCG, 500mg, tid, 4 weeks

cellulose

Placebo Comparator: cellulose, 500 mg tid, 4 weeks

Group Type PLACEBO_COMPARATOR

green tea extract EGCG

Intervention Type DIETARY_SUPPLEMENT

EGCG, 500mg, tid, 4 weeks

Interventions

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green tea extract EGCG

EGCG, 500mg, tid, 4 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Taipei City Hospital

OTHER_GOV

Sponsor Role collaborator

National Yang Ming Chiao Tung University

OTHER

Sponsor Role lead

Responsible Party

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Chung-Hua Hsu

Associated Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei City Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 18468736 (View on PubMed)

Hsu 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.

Reference Type BACKGROUND
PMID: 21649457 (View on PubMed)

Other Identifiers

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TCHIRB1010505

Identifier Type: -

Identifier Source: org_study_id

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