Acne Lesion CountsNCT01846338
The Effect of「GTT-EGCG」on Acne Women
A study testing green tea extract EGCG in people with Acne Lesion Counts, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne Lesion Counts
- What is being tested?
- green tea extract EGCG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2012to Sep 2013
- 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 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patient
- 20 to 45 years of age
- moderate or severe acne vulgaris as defined by the Investigator's Global Assessment (IGA; score of 3 or 4 on a scale from 0 to 5)
Who cannot join
- Received systemic retinoid or hormone treatment in the previous 3 months.
- Abnormal liver enzymes or kidney function tests (1.5 times higher than the upper normal limit)
- abnormal blood chemistry
- Pregnant or breast feeding women or the intention of becoming pregnant
- Concurrent systemic illness
- PCOS
- Very severe acne(IGA score5)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial.
Read the detailed description
change in acne lesions counts, hormone, quality of life
- Conditions
- Acne Lesion Counts
- Being tested
- green tea extract EGCG
- Keywords
- acne, 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.
green tea extract EGCGDietary supplement
EGCG, 500mg, tid, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| green tea extract EGCG | Experimental | experimental: green tea extract EGCG, 500mg , tid, 4 weeks Receives: Dietary Supplement: green tea extract EGCG |
| cellulose | Placebo comparator | Placebo Comparator: cellulose, 500 mg tid, 4 weeks Receives: Dietary Supplement: green tea extract EGCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
acne lesion counts
Measured: four weeks
Secondary outcomes (1)
quality of life, SF-12
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startOct 2012
- Primary completionJun 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne Lesion CountsStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Collaborators
- Taipei City Hospital
- Responsible party
- Principal investigator, Chung-Hua Hsu, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846338
- Sponsor's protocol ID
- TCHIRB1010505
- Status last verified
- May 2013
- First submitted
- 1 May 2013
- Last updated
- 3 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
PubMed 18468736Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.
PubMed 21649457
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of「GTT-EGCG」on Acne Women
- ClinicalTrials.gov ID
- NCT01846338
- Acronym / sponsor ID
- TCHIRB1010505
- Conditions
- Acne Lesion Counts
- Keywords
- acne, EGCG, green tea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Collaborators
- Taipei City Hospital
- Study start
- Oct 2012
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 3 May 2013 (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.
The aim of this study is to investigate the therapeutic effects of green tea extract on acne treatment and related hormone peptides by a double-blinded, randomized and controlled clinical trial.
Detailed description
change in acne lesions counts, hormone, quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| green tea extract EGCG | Experimental | Dietary Supplement: green tea extract EGCGexperimental: green tea extract EGCG, 500mg , tid, 4 weeks |
| cellulose | Placebo comparator | Dietary Supplement: green tea extract EGCGPlacebo Comparator: cellulose, 500 mg tid, 4 weeks |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patient
- 20 to 45 years of age
- moderate or severe acne vulgaris as defined by the Investigator's Global Assessment (IGA; score of 3 or 4 on a scale from 0 to 5)
Key exclusion criteria (7 listed)
- Received systemic retinoid or hormone treatment in the previous 3 months.
- Abnormal liver enzymes or kidney function tests (1.5 times higher than the upper normal limit)
- abnormal blood chemistry
- Pregnant or breast feeding women or the intention of becoming pregnant
- Concurrent systemic illness
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 |
|---|---|---|
| green tea extract EGCGEGCG, 500mg, tid, 4 weeks | Dietary supplement | cellulose, green tea extract EGCG |
Primary outcome
acne lesion counts
Time frame: four weeks
1 secondary outcome
quality of life, SF-12
Time frame: four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2013.
- Background: PubMed 18468736Hsu CH, Tsai TH, Kao YH, Hwang KC, Tseng TY, Chou P. Effect of green tea extract on obese women: a randomized, double-blind, placebo-controlled clinical trial. Clin Nutr. 2008 Jun;27(3):363-70. doi: 10.1016/j.clnu.2008.03.007. Epub 2008 May 12.
- Background: PubMed 21649457Hsu CH, Liao YL, Lin SC, Tsai TH, Huang CJ, Chou P. Does supplementation with green tea extract improve insulin resistance in obese type 2 diabetics? A randomized, double-blind, and placebo-controlled clinical trial. Altern Med Rev. 2011 Jun;16(2):157-63.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green tea extract EGCG in people with Acne Lesion Counts, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 May 2013. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
acne lesion counts (time frame: four weeks). 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 NCT01846338, which also lists 2 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 3 May 2013.