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

Sponsored by:	Renovo
Information provided by:	Renovo
ClinicalTrials.gov Identifier:	NCT00627536

Purpose

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

Condition	Intervention	Phase
Cicatrix	Drug: Avotermin Drug: Placebo	Phase II

MedlinePlus related topics: Scars

Drug Information available for: Avotermin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Renovo:

Primary Outcome Measures:

Scar appearance [ Time Frame: 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety: adverse events, local tolerability [ Time Frame: 7 months ] [ Designated as safety issue: Yes ]

Enrollment:	39
Study Start Date:	July 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Placebo Comparator Placebo	Drug: Placebo Matched to avotermin dosage strength
3: Experimental 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.
4: Placebo Comparator Placebo matched to avotermin 50ng/100μL/linear cm	Drug: Placebo Matched to avotermin dosage strength
5: Experimental 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.
6: Placebo Comparator Placebo matched to avotermin 200ng/100μL/linear cm	Drug: Placebo Matched to avotermin dosage strength
7: Experimental 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.
8: Placebo Comparator Placebo matched to avotermin 500ng/100μL/linear cm	Drug: Placebo Matched to avotermin dosage strength

Eligibility

Ages Eligible for Study:	18 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627536

Locations

United Kingdom
Renovo Clinical Trials Unit
Manchester, United Kingdom, M139XX

Sponsors and Collaborators

Renovo

Investigators

Principal Investigator:

James Bush, MBChB

Renovo

More Information

Responsible Party:	Renovo ( Mr Mark Cooper, Senior Vice President of Clinical Operations )
Study ID Numbers:	RN1001-0050
Study First Received:	February 22, 2008
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00627536
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Authority

Keywords provided by Renovo:

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

Study placed in the following topic categories:

Skin Diseases
Healthy
Cicatrix

ClinicalTrials.gov processed this record on January 16, 2009