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

Sponsor

Renovo (Industry)

Overall Status

Completed

CT.gov ID

NCT00627536

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cicatrix	Drug: Avotermin Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2006

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Avotermin 5ng/100μL/linear cm wound margin	Drug: Avotermin A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure. Other Names: Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 2 Placebo	Drug: Placebo Matched to avotermin dosage strength Other Names: None applicable
Experimental: 3 Avotermin 50ng/100μL/linear cm wound margin	Drug: Avotermin A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure. Other Names: Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 4 Placebo matched to avotermin 50ng/100μL/linear cm	Drug: Placebo Matched to avotermin dosage strength Other Names: None applicable
Experimental: 5 Avotermin 200ng/100μL/linear cm	Drug: Avotermin A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure. Other Names: Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 6 Placebo matched to avotermin 200ng/100μL/linear cm	Drug: Placebo Matched to avotermin dosage strength Other Names: None applicable
Experimental: 7 Avotermin 500ng/100μL/linear cm wound margin	Drug: Avotermin A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure. Other Names: Juvista, RN1001, transforming growth factor beta 3
Placebo Comparator: 8 Placebo matched to avotermin 500ng/100μL/linear cm	Drug: Placebo Matched to avotermin dosage strength Other Names: None applicable

Outcome Measures

Primary Outcome Measures

Scar appearance [7 months]

Secondary Outcome Measures

Safety: adverse events, local tolerability [7 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Renovo Clinical Trials Unit	Manchester		United Kingdom	M139XX

Sponsors and Collaborators

Renovo

Investigators

Principal Investigator: James Bush, MBChB, Renovo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00627536

Other Study ID Numbers:

RN1001-0050

First Posted:

Mar 3, 2008

Last Update Posted:

Mar 4, 2008

Last Verified:

Mar 1, 2008

Keywords provided by , ,

scarring, Juvista, avotermin, transforming growth factor beta 3, TGFB3

Additional relevant MeSH terms:

Cicatrix

Mitogens

Study Results

No Results Posted as of Mar 4, 2008