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.
Each subject received a total of six, 3mm punch biopsy wounds; three wounds to the upper inner aspect of each arm. Each punch biopsy site was randomly allocated to receive one of six treatments: Zesteem (0.02μg, 0.1μg, 0.2μg and 0.4μg/100μl), Placebo (vehicle), and Standard Care (moist wound healing dressings) only. Zesteem and Placebo were administered to marked, anaesthetised sites, by intradermal injection 10 to 30 minutes before wounding. Sites randomised to receive Standard Care only received no additional treatment before wounding. After wounding, all sites received moist wound healing dressings (Standard Care). Three days after wounding, all biopsy sites were anaesthetised and the wounds excised using a 5mm punch biopsy, for histological analysis. The Investigator closed all excision sites using sutures and Steri-strips to achieve a cosmetically acceptable result. Subjects attended a post-trial follow-up visit (13-18 days after dosing) where their sutures were removed and final safety assessments were performed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Renovo Clinical Trials Unit
Manchester, United Kingdom
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.
Time frame: Day 3
To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects.
Time frame: 13-18 Days
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Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
Intradermal placebo, 100μl administered once before punch biopsy