HealthyPhase 2NCT00134381

Green Tea and Ultraviolet Light-induced Skin Damage

A Phase 2 study testing Green Tea in people with Healthy, run by Rutgers, The State University of New Jersey at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to investigate whether topically applied constituents of green tea [caffeine or (-)-epigallocatechin gallate; EGCG] have a protective effect on skin exposed to ultraviolet light (UV). Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Green Tea
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: May 2003to Nov 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The subjects will be normal adult volunteers who are 18 to 65 years of age.

Who cannot join

Subjects who drink more than two cups of coffee, tea, or caffeinated soda/beverages per day.
Subjects who are unable to get an erythemic response (i.e., a sunburn).

Trial locations and contacts

1 site in 1 country.

United States1 site

UMDNJ Division of Clinical Pharmacology
New Brunswick, New Jersey, 08901

Other trials in United States

About this study

Official title: The Effects of Topically Applied Constituents of Green Tea on UV Induced Increase in p53 and Apoptotic Markers in the Skin of Human Volunteers

Read the detailed description

The purpose of this study is to investigate if topically applied constituents of green tea [caffeine or (-) - epigallocatechin gallate; EGCG] have a protective effect on skin exposed to ultraviolet light (UV). In the double-blinded study all subjects will receive 311 nanometer UVB light at a dose that is 0.5-1.5X their individual minimal erythema dose (MED). One part of the experiment will involve applying a topical natural product (caffeine or EGCG) and placebo to bilateral symmetric sites. The natural product and the placebo will be applied immediately after and at 1/2 hour, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 24 hours, 25 hours, and 27 hours after exposure to a 0.5-1.5 MED dose of UV light. Another part of the study involves performing skin biopsies. One will be done prior to UVB exposure, 2 will be done at 24 hours and 2 more will be done at 48 hours.

Conditions: Healthy
Being tested: Green Tea, Placebo
Keywords: Normal volunteer study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Green TeaDrug
Green tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)
PlaceboDrug
Placebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)

Study groups in NCT00134381
Study group	Role	What they receive
active drug	Active comparator	bilateral comparison of green tea constituent Receives: Drug: Green Tea
placebo	Placebo comparator	bilateral comparison of placebo vehicle Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds
The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Measured: 48 hrs
Change in UVB-Induced Apoptotic "Sunburn" Cells by Green Tea Compounds
The mean change in number of apoptotic "sunburn" cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Measured: 48 hr
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic "Sunburn" Cells
The percentage of apoptotic "sunburn" cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Measured: 48 hr
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells
The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Measured: 48 hr
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells
The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Measured: 48 hr

Secondary outcomes (2)

Effect of Green Tea Compounds on UVB-Induced Erythema
Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The mean scores at 48 hr were calculated.
Measured: 48 hrs
Effect of 4-6% Caffeine on UVB-Induced Erythema
Erythema of the right and left test sites was scored on a scale of 0-3 (0 = no evidence [no erythema]; 1 = mild [pink or light red color]; 2 = moderate [red color]; 3 = severe [very red or dark color]) including half-integer grading. Scoring was performed immediately after UVB exposure and at sequential time points thereafter. The erythema scores at 6, 8, and 24 hr post-UVB were averaged.
Measured: 24 hr

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2003Nov 2012

First posted24 Aug 2005 (estimated)
Study startMay 2003
Primary completionNov 2012
Study completionNov 2012

Why it stopped: Principal Investigator left institution before study could complete.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00134381
Sponsor's protocol ID: 3808
Status last verified: Aug 2017
First submitted: 22 Aug 2005
Last updated: 6 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Topically Applied Constituents of Green Tea on UV Induced Increase in p53 and Apoptotic Markers in the Skin of Human Volunteers
ClinicalTrials.gov ID: NCT00134381
Acronym / sponsor ID: 3808
Conditions: Healthy
Keywords: Normal volunteer study
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Principal Investigator left institution before study could complete.
Enrolment: 68 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: Rutgers University
Study start: May 2003
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 24 Aug 2005 (estimated)
Results: Posted 6 Sep 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
active drug	Active comparator	Drug: Green Teabilateral comparison of green tea constituent
placebo	Placebo comparator	Drug: Placebobilateral comparison of placebo vehicle

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

The subjects will be normal adult volunteers who are 18 to 65 years of age.

Key exclusion criteria (2 listed)

Subjects who drink more than two cups of coffee, tea, or caffeinated soda/beverages per day.
Subjects who are unable to get an erythemic response (i.e., a sunburn).

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 TeaGreen tea product (EGCG or caffeine) in vehicle will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)	Drug	active drug
PlaceboPlacebo (vehicle alone) will be applied immediately after and at sequential time points after exposure of a 5x5-cm area of skin to a dose of UVB that is 0.5-2 times the subject's minimal erythema dose (MED)	Drug	placebo

Primary outcome

Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds
Time frame: 48 hrs
The mean change in number of active caspase-3+ apoptotic keratinocytes between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Change in UVB-Induced Apoptotic "Sunburn" Cells by Green Tea Compounds
Time frame: 48 hr
The mean change in number of apoptotic "sunburn" cells between 0- and 48-hour time points was calculated for skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive active test substance (EGCG or caffeine) or placebo (vehicle) at sequential time points after UVB exposure.
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic "Sunburn" Cells
Time frame: 48 hr
The percentage of apoptotic "sunburn" cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells
Time frame: 48 hr
The percentage of caspase-3-positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.
Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Phospho-p53 (Ser15) Positive Cells
Time frame: 48 hr
The percentage of phospho-p53 (Ser15) positive cells was identified in the 48-hr time point skin biopsy samples of subjects who had been exposed to UVB on symmetrical right and left test sites which were then randomized to receive 4-6% caffeine in cream vehicle or placebo (cream vehicle) at sequential time points after UVB exposure.

2 secondary outcomes

Effect of Green Tea Compounds on UVB-Induced Erythema
Time frame: 48 hrs
Effect of 4-6% Caffeine on UVB-Induced Erythema
Time frame: 24 hr

Results and safety

Results posted to the registry on 6 Sep 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
EGCG in Acetone Vehicle (L Side: Active; R Side: Placebo)	1	1
EGCG in Acetone Vehicle (R Side: Active; L Side: Placebo)	2	2
Caffeine in Acetone Vehicle (L Side: Active; R Side: Placebo)	1	1
Caffeine in Acetone Vehicle (R Side: Active; L Side: Placebo)	2	2
Caffeine in Cream Vehicle (L Side: Active; R Side: Placebo)	31	31
Caffeine in Cream Vehicle (R Side: Active; L Side: Placebo)	31	29

Primary outcome: Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds

Time frame: 48 hrs. Mean (Standard Error). Unit: cells/mm

Measure	EGCG in Acetone Vehicle n = 3	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n = 3	Caffeine in Acetone Vehicle n = 3	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n = 3
Value	28.34 (18.51)	13.05 (9.98)	10.68 (3.61)	32.60 (28.14)

Population analysed: Six (6) subjects were randomized (split-body) to receive either EGCG (3 subjects) or caffeine (3 subjects) in acetone vehicle on a test site on one side of the body and placebo (acetone vehicle) on the test site on the other side of the body, after exposure to twice the individual subjects' minimal erythema dose (MED) of UVB.

Primary outcome: Change in UVB-Induced Apoptotic "Sunburn" Cells by Green Tea Compounds

Time frame: 48 hr. Mean (Standard Error). Unit: cells/mm

Measure	EGCG in Acetone Vehicle n = 3	Placebo (Acetone Vehicle in Subjects Who Received EGCG) n = 3	Caffeine in Acetone Vehicle n = 3	Placebo (Acetone Vehicle in Subjects Who Received Caffeine) n = 3
Value	18.94 (8.18)	14.79 (7.43)	28.86 (8.00)	43.62 (29.22)

Primary outcome: Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Apoptotic "Sunburn" Cells

Time frame: 48 hr. Mean (Standard Error). Unit: percentage of "sunburn" cells

Measure	Caffeine in Vehicle Cream (1.0 MED Group) n = 20	Placebo Cream (1.0 MED Group) n = 20	Caffeine in Vehicle Cream (1.5 MED Group) n = 26	Placebo Cream (1.5 MED Group) n = 26
Value	7.50 (2.06)	4.93 (1.54)	5.10 (0.80)	4.63 (0.60)

Population analysed: Twenty (20) subjects received caffeine on one test site and placebo on the other site after exposure to individual subjects' minimal erythema dose (MED) of UVB.Twenty-six (26) subjects received caffeine on one test site and placebo on the other site after exposure to UVB that was 1.5 times subjects' individual minimal erythema dose (MED).

Primary outcome: Effect of Topical Applications of 4-6% Caffeine on UVB-Induced Increases in Caspase-3-Positive Cells

Time frame: 48 hr. Mean (Standard Error). Unit: percentage of caspase-3-positive cells

Measure	Caffeine in Vehicle Cream (1.0 MED Group) n = 20	Placebo Cream (1.0 MED Group) n = 20	Caffeine in Vehicle Cream (1.5 MED Group) n = 26	Placebo Cream (1.5 MED Group) n = 26
Value	6.54 (1.85)	4.53 (1.16)	4.38 (0.92)	3.15 (0.46)

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Bilateral Comparison	0 of 68 (0%)	6 of 68 (8.8%)	Not reported

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Melissa Magliocco, MD principal investigator

Rutgers, The State University of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Green Tea in people with Healthy, run by Rutgers, The State University of New Jersey at 1 site in United States.

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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 6 Sep 2017. 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in UVB-Induced Active Caspase-3-Positive Keratinocytes by Green Tea Compounds (time frame: 48 hrs). The study lists 5 primary outcomes in all. 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 NCT00134381.

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 6 Sep 2017.