Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing
This study has been completed.
Sponsor:
Renovo
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00984386
First received: September 24, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cicatrix Wound-healing |
Drug: Zesteem Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 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. |
Resource links provided by NLM:
MedlinePlus related topics:
Scars
Drug Information available for:
Estradiol
Estradiol cypionate
Estradiol valerate
Estradiol acetate
Estradiol hemihydrate
U.S. FDA Resources
Further study details as provided by Renovo:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects. [ Time Frame: 13-18 Days ] [ Designated as safety issue: Yes ]
| Enrollment: | 44 |
| Study Start Date: | March 2005 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intradermal Zesteem |
Drug: Zesteem
Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy
Other Names:
Drug: Zesteem
Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
Other Names:
Drug: Zesteem
Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
Other Names:
Drug: Zesteem
Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Placebo
Intradermal placebo, 100μl administered once before punch biopsy
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | John Hutchison, Renovo |
| ClinicalTrials.gov Identifier: | NCT00984386 History of Changes |
| Other Study ID Numbers: | RN1002-028 |
| Study First Received: | September 24, 2009 |
| Last Updated: | September 24, 2009 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Renovo:
|
Cicatrix Scar Wound-healing |
Zesteem 17β-Estradiol RN1002 |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Estrogens |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female |
ClinicalTrials.gov processed this record on May 19, 2013