Status:
COMPLETED
Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing
Lead Sponsor:
Renovo
Conditions:
Cicatrix
Wound-healing
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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-me...
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: Zeste...
Eligibility Criteria
Inclusion
- 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
- 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 times upper limit of normal), congestive heart failure, current active malignancy or history of malignancy in the last 5 years, immunosuppression or chemotherapy within the last 12 months, a history of radiotherapy or diabetes mellitus
- Subjects with a history of hypersensitivity to any of the drugs or dressings used in this trial
- Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration
- Subjects who are taking regular, continuous, oral corticosteroid therapy
- Subjects undergoing investigations or changes in management for an existing medical condition
- Subjects with a history of drug abuse
- Subjects with a positive drugs of abuse test for cocaine, amphetamines, methamphetamines, opiates or benzodiazepines during the screening period
- Subjects who, in the opinion of the investigator, are unlikely to complete the trial for whatever reason
- Female subjects who are currently taking any form of hormone replacement therapy or contraceptive medication
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2005
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00984386
Start Date
March 1 2005
End Date
April 1 2005
Last Update
September 25 2009
Active Locations (1)
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1
Renovo Clinical Trials Unit
Manchester, United Kingdom, M13 9XX