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Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing

Primary Purpose

Cicatrix, Wound-healing

Status

Completed

Phase

Phase 2

Locations

United Kingdom

Study Type

Interventional

Intervention

Zesteem

Placebo

About this trial

This is an interventional treatment trial for Cicatrix focused on measuring Cicatrix, Scar, Wound-healing, Zesteem, 17β-Estradiol, RN1002

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Renovo Clinical Trials Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intradermal Zesteem

Placebo

Arm Description

Outcomes

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.

Secondary Outcome Measures

To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects.

Full Information

NCT ID

NCT00984386

First Posted

September 24, 2009

Last Updated

September 24, 2009

Sponsor

Renovo

1. Study Identification

Unique Protocol Identification Number

NCT00984386

Brief Title

Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing

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.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

April 2005 (Actual)

Study Completion Date

April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Renovo

4. Oversight

Data Monitoring Committee

5. Study Description

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-menopausal.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cicatrix, Wound-healing

Keywords

Cicatrix, Scar, Wound-healing, Zesteem, 17β-Estradiol, RN1002

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intradermal Zesteem

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Zesteem

Other Intervention Name(s)

17β-Estradiol, RN1002

Intervention Description

Intradermal Zesteem, 0.02μg/100μl administered once before punch biopsy

Intervention Type

Drug

Intervention Name(s)

Zesteem

Other Intervention Name(s)

17β-Estradiol, RN1002

Intervention Description

Intradermal Zesteem, 0.1μg/100μl administered once before punch biopsy

Intervention Type

Drug

Intervention Name(s)

Zesteem

Other Intervention Name(s)

17β-Estradiol, RN1002

Intervention Description

Intradermal Zesteem, 0.2μg/100μl administered once before punch biopsy

Intervention Type

Drug

Intervention Name(s)

Zesteem

Other Intervention Name(s)

17β-Estradiol, RN1002

Intervention Description

Intradermal Zesteem, 0.4μg/100μl administered once before punch biopsy

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intradermal placebo, 100μl administered once before punch biopsy

Primary Outcome Measure Information:

Title

Time Frame

Day 3

Secondary Outcome Measure Information:

Title

To assess safety and tolerability of intradermal Zesteem in male and post-menopausal female subjects.

Time Frame

13-18 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jonathan Duncan

Organizational Affiliation

Renovo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Renovo Clinical Trials Unit

City

Manchester

ZIP/Postal Code

M13 9XX

Country

United Kingdom

12. IPD Sharing Statement

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Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing

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