Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing (NCT00984386) | Clinical Trial Compass
CompletedPhase 2
Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing
United Kingdom44 participantsStarted 2005-03
Plain-language 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.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* Male subjects aged 18-85 years, and female subjects who are at least two years postmenopausal (quantified by a serum test result of estradiol \<90 pmol/L and FSH \> 31 IU/L) who have given written informed consent
* Subjects with a BMI within the permitted range for their height using Quetelet's index-weight (kg)/height² (m). The permitted index is 15-55 kg/m2
* Subjects with, in the opinion of the investigator, clinically acceptable results for laboratory safety tests performed within 28 days of the first trial dose administration
Exclusion Criteria:
* Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring
* Subjects with tattoos or previous scars within 3cm of the area to be biopsied
* Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring
* Subjects who have had surgery in the area to be biopsied within one year of the first dosing day
* Subjects with a history of a bleeding disorder
* Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial
* Subjects with any clinically significant medical condition or history that would impair wound healing including: significant rheumatoid arthritis, chronic renal impairment significant for their age, significant hepatic impairment (LFTs \>3 …
What they're measuring
1
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.