EGCG Improves Acne by Modulating Molecular Targets (EGCG)
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
topical EGCG application on acne
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring EGCG, green tea
Eligibility 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.
Sites / Locations
- Department of Dermatology, Seoul National University College of Medicine,
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Topical EGCG 1%
topical EGCG 5%
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Assessment of acne severity
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
Standardized clinical photographs
Full Information
NCT ID
NCT01687556
First Posted
July 23, 2010
Last Updated
September 13, 2012
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01687556
Brief Title
EGCG Improves Acne by Modulating Molecular Targets
Acronym
EGCG
Official Title
Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
EGCG, green tea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical EGCG 1%
Arm Type
Active Comparator
Arm Description
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).
Arm Title
topical EGCG 5%
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
topical EGCG application on acne
Other Intervention Name(s)
Green tea extract, EGCG
Intervention Description
two times application of topical EGCG on acne lesion
Primary Outcome Measure Information:
Title
Assessment of acne severity
Description
Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale
Time Frame
8 week after baseline
Secondary Outcome Measure Information:
Title
2-mm punch biopsy of acne lesion on the EGCG-treated sides
Time Frame
8 week after baseline
Title
Standardized clinical photographs
Time Frame
8 week after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Hun Suh, M.D., Ph.D.
Organizational Affiliation
Department of Dermatology, Seoul National University College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Department of Dermatology, Seoul National University College of Medicine,
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
9522243
Citation
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.
Results Reference
background
PubMed Identifier
10679280
Citation
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.
Results Reference
background
PubMed Identifier
10561043
Citation
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.
Results Reference
background
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EGCG Improves Acne by Modulating Molecular Targets
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