EGCG Improves Acne by Modulating Molecular Targets
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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 |
- 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
- 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 |
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| Korea, Republic of | |
| Department of Dermatology, Seoul National University College of Medicine, | |
| Seoul, Korea, Republic of, 110-744 | |
| 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 Epigallocatechin gallate Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Neuroprotective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013