NCT00984386

Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing

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.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Cicatrix
• Wound-healing

Interventions

Type	Name	Description
DRUG	Zesteem	Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy
DRUG	Zesteem	Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
DRUG	Zesteem	Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
DRUG	Zesteem	Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
DRUG	Placebo	Intradermal placebo, 100μl administered once before punch biopsy

Timeline

• Start date: 2005-03-01
• Primary completion: 2005-04-01
• Completion: 2005-04-01
• First posted: 2009-09-25
• Last updated: 2009-09-25

Locations

1 site across 1 country: United Kingdom