Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing
September 24, 2009 updated by: Renovo
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.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manchester, United Kingdom, M13 9XX
- Renovo Clinical Trials Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
PLACEBO_COMPARATOR: Placebo
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Intradermal placebo, 100μl administered once before punch biopsy
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EXPERIMENTAL: Intradermal Zesteem
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Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy
Other Names:
Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
Other Names:
Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
Other Names:
Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
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Day 3
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects.
Time Frame: 13-18 Days
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13-18 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2005
Primary Completion (ACTUAL)
April 1, 2005
Study Completion (ACTUAL)
April 1, 2005
Study Registration Dates
First Submitted
September 24, 2009
First Submitted That Met QC Criteria
September 24, 2009
First Posted (ESTIMATE)
September 25, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
September 25, 2009
Last Update Submitted That Met QC Criteria
September 24, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Wounds and Injuries
- Cicatrix
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Estradiol
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- RN1002-028
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.