Clinical trial NCT01687556: EGCG Improves Acne by Modulating Molecular Targets
Official title: Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Keywords: EGCG
green tea
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2012-09-19
Enrollment: 35
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Assessment of acne severity
timeFrame: 8 week after baseline
Secondary outcomes:
measure: 2-mm punch biopsy of acne lesion on the EGCG-treated sides
timeFrame: 8 week after baseline
measure: Standardized clinical photographs
timeFrame: 8 week after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University College of Medicine,
Study officials:
affiliation: Department of Dermatology, Seoul National University College of Medicine
name: Dae Hun Suh, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.