Study Stopped
Principal Investigator left institution before study could complete.
Green Tea and Ultraviolet Light-induced Skin Damage
The Effects of Topically Applied Constituents of Green Tea on UV Induced Increase in p53 and Apoptotic Markers in the Skin of Human Volunteers
1 other identifier
interventional
68
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 healthy
Started May 2003
Longer than P75 for phase_2 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
August 22, 2005
CompletedFirst Posted
Study publicly available on registry
August 24, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
September 6, 2017
CompletedSeptember 6, 2017
August 1, 2017
9.5 years
August 22, 2005
April 11, 2017
August 3, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
48 hr
Secondary Outcomes (2)
Effect of Green Tea Compounds on UVB-Induced Erythema
48 hrs
Effect of 4-6% Caffeine on UVB-Induced Erythema
24 hr
Study Arms (2)
active drug
ACTIVE COMPARATORbilateral comparison of green tea constituent
placebo
PLACEBO COMPARATORbilateral comparison of placebo vehicle
Interventions
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 (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)
Eligibility Criteria
You may qualify if:
- The subjects will be normal adult volunteers who are 18 to 65 years of age.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rutgers, The State University of New Jerseylead
- Rutgers Universitycollaborator
Study Sites (1)
UMDNJ Division of Clinical Pharmacology
New Brunswick, New Jersey, 08901, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Early termination leading to small numbers of subjects analyzed
Results Point of Contact
- Title
- Dr M Magliocco
- Organization
- UMDNJ-Robert Wood Johnson Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Magliocco, MD
Rutgers, The State University of New Jersey
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2005
First Posted
August 24, 2005
Study Start
May 1, 2003
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
September 6, 2017
Results First Posted
September 6, 2017
Record last verified: 2017-08