Acne VulgarisEGCGNCT01687556
EGCG Improves Acne by Modulating Molecular Targets
A study testing topical EGCG application on acne in people with Acne Vulgaris, run by Seoul National University Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- topical EGCG application on acne
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2005to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age of at least 15 years
- clinical diagnosis of mild to moderate acne vulgaris
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Dermatology, Seoul National University College of Medicine,
Seoul, 110-744
About this study
Official title: Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- topical EGCG application on acne
- Keywords
- EGCG, green tea
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical EGCG application on acneOther
Also called Green tea extract, EGCG
two times application of topical EGCG on acne lesion
| Study group | Role | What they receive |
|---|---|---|
| Topical EGCG 1% | 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). Receives: Other: topical EGCG application on acne |
| topical EGCG 5% | 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). Receives: Other: topical EGCG application on acne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of acne severity
Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale
Measured: 8 week after baseline
Secondary outcomes (2)
2-mm punch biopsy of acne lesion on the EGCG-treated sides
Measured: 8 week after baseline
Standardized clinical photographs
Measured: 8 week after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2012 (estimated)
- Study startJul 2005
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dae Hun Suh, Seoul National University Hospital
- Investigators
- Dae Hun Suh, M.D., Ph.D., Study director, Department of Dermatology, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01687556
- Sponsor's protocol ID
- 04-2005-043-0
- Acronym
- EGCG
- Status last verified
- Sep 2012
- First submitted
- 23 Jul 2010
- Last updated
- 19 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9522243Abe 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.
PubMed 10679280Alexis 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.
PubMed 10561043
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigallocatechin-3-Gallate Improves Acne in Humans by Modulating Intracellular Molecular Targets and Inhibiting P. Acnes
- ClinicalTrials.gov ID
- NCT01687556
- Acronym / sponsor ID
- EGCG / 04-2005-043-0
- Conditions
- Acne Vulgaris
- Keywords
- EGCG, green tea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical EGCG 1% | Active comparator | Other: topical EGCG application on acneSeventeen 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). |
| topical EGCG 5% | Experimental | Other: topical EGCG application on acneEighteen 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). |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age of at least 15 years
- clinical diagnosis of mild to moderate acne vulgaris
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical EGCG application on acneAlso: Green tea extract, EGCGtwo times application of topical EGCG on acne lesion | Other | Topical EGCG 1%, topical EGCG 5% |
Primary outcome
Assessment of acne severity
Time frame: 8 week after baseline
Lesion counts of non-inflammatory lesions (closed comedone, open comedone) and severity measured by Reeds revised scale
2 secondary outcomes
2-mm punch biopsy of acne lesion on the EGCG-treated sides
Time frame: 8 week after baseline
Standardized clinical photographs
Time frame: 8 week after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2012.
- Background: PubMed 9522243Dominguez 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.
- Background: PubMed 10679280Abe 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.
- Background: PubMed 10561043Alexis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Hun Suh, M.D., Ph.D. study director
Department of Dermatology, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing topical EGCG application on acne in people with Acne Vulgaris, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of acne severity (time frame: 8 week after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01687556, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2012.