A Single Site, Placebo and Standard Care Controlled, Double Blind, Randomised Trial to Investigate the Efficacy of Four Doses of Zesteem in Accelerating Early Wound Healing of Punch Biopsy Skin Wounds.
Sponsor study identifier
interventional
44
1 country
1
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2005
Actual (reported)Study Completion
April 2005
Actual (reported)The purpose of this study is to investigate early wound healing of one application of four different doses of intradermal Zesteem (17β-Estradiol) in male subjects and female subjects two years post-menopausal.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2005
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
April 2005
Actual (reported)April 2005
Actual (reported)September 24, 2009
Actual (reported)September 25, 2009
Actual (reported)To assess acceleration of early wound healing in male and postmenopausal female subjects following administration of intradermal Zesteem. The primary trial endpoint will be the distance travelled by the epithelium over the biopsy site.
Day 3
To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects.
13-18 Days
Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy
Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
Renovo Clinical Trials Unit
Manchester, M13 9XX, United Kingdom
Jonathan Duncan
Renovo
44 participants (actual enrollment reported by the registry).
First Submitted
September 24, 2009
First Posted
September 25, 2009
Study Start
March 2005
Date type not reportedThis date has not been verified as actual or estimated.
Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
Intradermal placebo, 100μl administered once before punch biopsy
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Primary Completion
April 2005
Actual (reported)Study Completion
April 2005
Actual (reported)Last Updated
September 25, 2009
Record last verified: 2009-09
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Source: ClinicalTrials.gov.
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