NCT01687556

Brief Summary

Epigallocatechin-3-gallate (EGCG) may improve acne vulgaris

  • major polyphenolic constituent in green tea
  • known as potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and antimicrobial activities
  • lipid-lowering and antiandrogenic properties was reported
  • EGCG can improve acne vulgaris via one of the above mentioned actions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2010

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

September 19, 2012

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

11 months

First QC Date

July 23, 2010

Last Update Submit

September 13, 2012

Conditions

Acne Vulgaris

Keywords

EGCGgreen tea

Outcome Measures

Primary Outcomes (1)

  • Assessment of acne severity

    Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale

    8 week after baseline

Secondary Outcomes (2)

  • 2-mm punch biopsy of acne lesion on the EGCG-treated sides

    8 week after baseline

  • Standardized clinical photographs

    8 week after baseline

Study Arms (2)

Topical EGCG 1%

ACTIVE COMPARATOR

Seventeen subjects were designated to use 1% EGCG .Since baseline visits, affected areas of randomly allocated half sides were treated with 1% solution twice daily, whereas those of the opposite sides were treated with vehicle only (3% ethanol).

Other: topical EGCG application on acne

topical EGCG 5%

EXPERIMENTAL

Eighteen subjects were designated to use 5% EGCG, to evaluate a dose-response relationship. Since baseline visits, affected areas of randomly allocated half sides were treated with 5% EGCG solution twice daily, whereas those of the opposite sides were treated with vehicle only (3% ethanol).

Other: topical EGCG application on acne

Interventions

topical EGCG application on acneOTHER

two times application of topical EGCG on acne lesion

Also known as: Green tea extract, EGCG
Topical EGCG 1%topical EGCG 5%

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age of at least 15 years
  • clinical diagnosis of mild to moderate acne vulgaris

You may not qualify if:

  • known pregnancy or lactation
  • any medical illness that might influence the results of the study,
  • a previous history of oral acne medication or surgical procedures including laser treatment within 6 month and topical medication within 4 weeks of study enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Seoul National University College of Medicine,

Seoul, 110-744, South Korea

Location

Related Publications (3)

  • Dominguez J, Hojyo MT, Celayo JL, Dominguez-Soto L, Teixeira F. Topical isotretinoin vs. topical retinoic acid in the treatment of acne vulgaris. Int J Dermatol. 1998 Jan;37(1):54-5. doi: 10.1046/j.1365-4362.1998.00254.x.

    PMID: 9522243BACKGROUND

  • Abe I, Seki T, Umehara K, Miyase T, Noguchi H, Sakakibara J, Ono T. Green tea polyphenols: novel and potent inhibitors of squalene epoxidase. Biochem Biophys Res Commun. 2000 Feb 24;268(3):767-71. doi: 10.1006/bbrc.2000.2217.

    PMID: 10679280BACKGROUND

  • Alexis AF, Jones VA, Stiller MJ. Potential therapeutic applications of tea in dermatology. Int J Dermatol. 1999 Oct;38(10):735-43. doi: 10.1046/j.1365-4362.1999.00796.x. No abstract available.

    PMID: 10561043BACKGROUND

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Teaepigallocatechin gallate

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Dae Hun Suh, M.D., Ph.D.

    Department of Dermatology, Seoul National University College of Medicine

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 23, 2010

First Posted

September 19, 2012

Study Start

July 1, 2005

Primary Completion

June 1, 2006

Study Completion

June 1, 2006

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations

KR(1)