Completed

EGCGEpigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes

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What is being tested

topical EGCG application on acne

+ topical EGCG application on acne

Other
Who is being recruted

Sebaceous Gland Diseases+2

+ Skin Diseases

+ Skin and Connective Tissue Diseases

From 15 to 40 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: July 2005
See protocol details

Summary

Principal SponsorSeoul National University Hospital
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2005

Actual date on which the first participant was enrolled.

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.

Principal SponsorSeoul National University Hospital
Last updated: September 19, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

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

35 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 15 to 40 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Sebaceous Gland DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAcneiform EruptionsAcne Vulgaris

Criteria

2 inclusion criteria required to participate
age of at least 15 years

clinical diagnosis of mild to moderate acne vulgaris

3 exclusion criteria prevent from participating
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

any medical illness that might influence the results of the study

known pregnancy or lactation

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Group II

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Department of Dermatology, Seoul National University College of Medicine,

Seoul, South KoreaOpen Department of Dermatology, Seoul National University College of Medicine, in Google Maps
CompletedOne Study Center