The Effect of「GTT-EGCG」on Acne Women

May 2, 2013 updated by: Chung-Hua Hsu, National Yang Ming University
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

change in acne lesions counts, hormone, quality of life

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 886
        • Taipei City Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: green tea extract EGCG
experimental: green tea extract EGCG, 500mg , tid, 4 weeks
Dietary supplement: green tea extract EGCG
EGCG, 500mg, tid, 4 weeks
PLACEBO_COMPARATOR: cellulose
Placebo Comparator: cellulose, 500 mg tid, 4 weeks
Dietary supplement: green tea extract EGCG
EGCG, 500mg, tid, 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
acne lesion counts
Time Frame: four weeks
four weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
quality of life, SF-12
Time Frame: four weeks
four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Yang Ming University

Collaborators

Taipei City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ANTICIPATED)

June 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

May 1, 2013

First Submitted That Met QC Criteria

May 2, 2013

First Posted (ESTIMATE)

May 3, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 3, 2013

Last Update Submitted That Met QC Criteria

May 2, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCHIRB1010505

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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