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Green Tea and Ultraviolet Light-induced Skin Damage

This study has been terminated.
(Principal Investigator left institution before study could complete.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00134381
First Posted: August 24, 2005
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rutgers University
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
  Purpose
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).

Condition Intervention Phase
Healthy Drug: Green Tea Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Effect of Green Tea Compounds on UVB-Induced Erythema [ Time Frame: 48 hrs ]
    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.

  • Effect of 4-6% Caffeine on UVB-Induced Erythema [ Time Frame: 24 hr ]
    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.


Enrollment: 68
Study Start Date: May 2003
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: active drug
bilateral comparison of green tea constituent
Drug: Green Tea
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)
Placebo Comparator: placebo
bilateral comparison of placebo vehicle
Drug: Placebo
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)

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134381


Locations
United States, New Jersey
UMDNJ Division of Clinical Pharmacology
New Brunswick, New Jersey, United States, 08901
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Rutgers University
Investigators
Principal Investigator: Melissa Magliocco, MD Rutgers, The State University of New Jersey
  More Information

Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00134381     History of Changes
Other Study ID Numbers: 3808
First Submitted: August 22, 2005
First Posted: August 24, 2005
Results First Submitted: April 11, 2017
Results First Posted: September 6, 2017
Last Update Posted: September 6, 2017
Last Verified: August 2017

Keywords provided by Rutgers, The State University of New Jersey:
Normal volunteer study