Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions

Cicatrix Clinical Trial

Official title:

A Double-Blind, Placebo-Controlled, Randomised Dose-Ranging Trial to Investigate the Efficacy of Avotermin (Juvista) in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627536
• Other study ID #: RN1001-0050
• Status: Completed
• Phase: Phase 2
• First received: February 22, 2008
• Last updated: March 3, 2008
• Start date: July 2006
• Est. completion date: March 2007

Study information

• Verified date: March 2008
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Authority
• Study type: Interventional

Clinical Trial Summary

This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Males and females aged 18-85 years who had given written informed consent.

• Subjects with a body mass index within 15 to 35 kg/m2.

• Subjects with clinically acceptable results for the laboratory tests

• Female subjects of child bearing potential who are using acceptable method(s) of contraception.

Exclusion Criteria:

• Subjects with history or evidence of hypertrophic or keloid scarring.

• Subjects with tattoos or previous scars within 3cm of the area to be incised.

• Subjects with prior surgery in the area to be incised within one year of the first dosing day.

• Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy.

• Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial.

• Subjects with a clinically significant skin disorder that is chronic or currently active.

• Subjects with any clinically significant medical condition or history that would impair wound healing.

• Subjects with a history of drug 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, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period.

• Subjects who are considered unlikely to complete the trial for whatever reason.

• Subjects with a clinically significant neurological impairment or disease.

• Subjects with any active infection.

• Subjects who are pregnant or lactating.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix

Intervention

Drug:
• Avotermin
A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.
• Placebo
Matched to avotermin dosage strength

Locations

Country	Name	City	State
United Kingdom	Renovo Clinical Trials Unit	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scar appearance		7 months	No
Secondary	Safety: adverse events, local tolerability		7 months	Yes