The Effect of「GTT-EGCG」on Acne Women

Acne Lesion Counts Clinical Trial

Official title:

The Effect of「GTT-EGCG」on Acne Women

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01846338
• Other study ID #: TCHIRB1010505
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 1, 2013
• Last updated: May 2, 2013
• Start date: October 2012
• Est. completion date: September 2013

Study information

• Verified date: May 2013
• Source: National Yang Ming University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Description:

change in acne lesions counts, hormone, quality of life

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: September 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Lesion Counts

Intervention

Dietary Supplement:
• green tea extract EGCG
EGCG, 500mg, tid, 4 weeks

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Yang Ming University	Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acne lesion counts		four weeks	No
Secondary	quality of life, SF-12		four weeks	No