Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing

This study has been completed.
Sponsor:
Information provided by:
Renovo
ClinicalTrials.gov Identifier:
NCT00984386
First received: September 24, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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:


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:
  • 17β-Estradiol
  • RN1002
Drug: Zesteem
Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy
Other Names:
  • 17β-Estradiol
  • RN1002
Drug: Zesteem
Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy
Other Names:
  • 17β-Estradiol
  • RN1002
Drug: Zesteem
Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy
Other Names:
  • 17β-Estradiol
  • RN1002
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984386

Locations
United Kingdom
Renovo Clinical Trials Unit
Manchester, United Kingdom, M13 9XX
Sponsors and Collaborators
Renovo
Investigators
Principal Investigator: Jonathan Duncan Renovo
  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 17 beta-cypionate
Estradiol 3-benzoate
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 September 18, 2014