EGCG Improves Acne by Modulating Molecular Targets

Acne Vulgaris Clinical Trial

— EGCG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01687556
• Other study ID #: 04-2005-043-0
• Status: Completed
• Phase: N/A
• First received: July 23, 2010
• Last updated: September 13, 2012
• Start date: July 2005
• Est. completion date: June 2006

Study information

• Verified date: September 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Other:
• topical EGCG application on acne
two times application of topical EGCG on acne lesion

Locations

Country	Name	City	State
Korea, Republic of	Department of Dermatology, Seoul National University College of Medicine,	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View Citation

Alexis AF, Jones VA, Stiller MJ. Potential therapeutic applications of tea in dermatology. Int J Dermatol. 1999 Oct;38(10):735-43. Review. — View Citation

Domínguez J, Hojyo MT, Celayo JL, Domínguez-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	2-mm punch biopsy of acne lesion on the EGCG-treated sides		8 week after baseline	Yes
Secondary	Standardized clinical photographs		8 week after baseline	Yes