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The Effect of「GTT-EGCG」on Acne Women

Primary Purpose

Acne Lesion Counts

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
green tea extract EGCG
Sponsored by
National Yang Ming University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Lesion Counts focused on measuring acne, EGCG, green tea

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • Taipei City Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

green tea extract EGCG

cellulose

Arm Description

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

Placebo Comparator: cellulose, 500 mg tid, 4 weeks

Outcomes

Primary Outcome Measures

acne lesion counts

Secondary Outcome Measures

quality of life, SF-12

Full Information

First Posted
May 1, 2013
Last Updated
May 2, 2013
Sponsor
National Yang Ming University
Collaborators
Taipei City Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01846338
Brief Title
The Effect of「GTT-EGCG」on Acne Women
Official Title
The Effect of「GTT-EGCG」on Acne Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2012 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
September 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
Collaborators
Taipei City Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Lesion Counts
Keywords
acne, EGCG, green tea

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
green tea extract EGCG
Arm Type
Experimental
Arm Description
experimental: green tea extract EGCG, 500mg , tid, 4 weeks
Arm Title
cellulose
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator: cellulose, 500 mg tid, 4 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
green tea extract EGCG
Intervention Description
EGCG, 500mg, tid, 4 weeks
Primary Outcome Measure Information:
Title
acne lesion counts
Time Frame
four weeks
Secondary Outcome Measure Information:
Title
quality of life, SF-12
Time Frame
four weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
Taipei City Hospital
City
Taipei
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
18468736
Citation
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.
Results Reference
background
PubMed Identifier
21649457
Citation
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.
Results Reference
background

Learn more about this trial

The Effect of「GTT-EGCG」on Acne Women

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