Investigation of the Efficacy of Zesteem in Accelerating Early Wound Healing

NCT00984386 | Completed Phase 2

• 1 other identifier: RN1002-028
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix; Wound-healing

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 3

Secondary Outcomes (1)

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

  13-18 Days

Study Arms (2)

Intradermal Zesteem

EXPERIMENTAL

Drug: Zesteem

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Zesteem DRUG

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

Also known as: 17β-Estradiol, RN1002

Intradermal Zesteem

Placebo DRUG

Intradermal placebo, 100μl administered once before punch biopsy

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo Clinical Trials Unit

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Jonathan Duncan

  Renovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: March 1, 2005
• Primary Completion: April 1, 2005
• Study Completion: April 1, 2005
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

GB (1)