EGCG Improves Acne by Modulating Molecular Targets

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dae Hun Suh, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01687556
First received: July 23, 2010
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

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.

Condition Intervention
Acne Vulgaris
Other: topical EGCG application on acne

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • Assessment of acne severity [ Time Frame: 8 week after baseline ] [ Designated as safety issue: Yes ]
    Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale


Secondary Outcome Measures:
  • 2-mm punch biopsy of acne lesion on the EGCG-treated sides [ Time Frame: 8 week after baseline ] [ Designated as safety issue: Yes ]
  • Standardized clinical photographs [ Time Frame: 8 week after baseline ] [ Designated as safety issue: Yes ]

Enrollment: 35
Study Start Date: July 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Topical EGCG 1%
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
two times application of topical EGCG on acne lesion
Other Name: Green tea extract, EGCG
Experimental: topical EGCG 5%
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
two times application of topical EGCG on acne lesion
Other Name: Green tea extract, EGCG

Detailed Description:

Acne vulgaris is one of the most prevalent skin disorders of sebaceous follicles, affecting more than 85% of adolescents in United States. Acne can persist throughout the adulthood, and even a mild form of acne might progress to permanent scarring on the face, chest and back, thereby causing significant physical and psychosocial morbidities. Acne is a multifactorial disease of which etiology has not been fully elucidated, although considerable progress has been made in understanding its pathogenesis during last decade. The major pathogenic features of acne include abnormal ductal keratinization, sebum overproduction, Propionibacterium acnes, and inflammation. Common acne medications such as topical retinoids, antibiotics and isotretinoin are associated with irritation and incomplete responses, increased bacterial resistance or untoward side events, respectively. Thus there is a continuing need for a novel, effective agent targeting different aspects of acne pathogenesis, with minimal side effects.

In the recent decade, epigallocatechin-3-gallate (EGCG), the major polyphenolic constituent in green tea, has attracted much interest on account of its potent anti-carcinogenic, anti-inflammatory, anti-proliferative, and antimicrobial activities. Preclinical, observational, and clinical trial data have indicated that EGCG can inhibit tumor initiation, promotion, progression, and angiogenesis. EGCG also suppresses neutrophil chemotaxis, and has been suggested to improve many diseases that have inflammatory components such as diabetes, kidney injuries, arthritis, allergies, dental caries, cardiovascular, gastrointestinal, and neurodegenerative diseases. In skin, EGCG has been investigated mainly in light of antioxidative, immunopotentiating and anticarcinogenic properties against chemicals or ultraviolet irradiation. Moreover, EGCG has lipid-lowering and antiandrogenic properties, and can downregulate peroxisome proliferator-activated receptor-γ expression. Based on these observations, it can be inferred that EGCG might be effective in the treatment of acne.

  Eligibility

Ages Eligible for Study:   15 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01687556

Locations
Korea, Republic of
Department of Dermatology, Seoul National University College of Medicine,
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Director: Dae Hun Suh, M.D., Ph.D. Department of Dermatology, Seoul National University College of Medicine
  More Information

Publications:
Responsible Party: Dae Hun Suh, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01687556     History of Changes
Other Study ID Numbers: 04-2005-043-0
Study First Received: July 23, 2010
Last Updated: September 13, 2012
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
EGCG
green tea

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on September 18, 2014