NCT00627536

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2008

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2008

Enrollment Period

8 months

First QC Date

February 22, 2008

Last Update Submit

March 3, 2008

Conditions

Cicatrix

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Scar appearance

    7 months

Secondary Outcomes (1)

  • Safety: adverse events, local tolerability

    7 months

Study Arms (8)

1

EXPERIMENTAL

Avotermin 5ng/100μL/linear cm wound margin

Drug: Avotermin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

3

EXPERIMENTAL

Avotermin 50ng/100μL/linear cm wound margin

Drug: Avotermin

4

PLACEBO COMPARATOR

Placebo matched to avotermin 50ng/100μL/linear cm

Drug: Placebo

5

EXPERIMENTAL

Avotermin 200ng/100μL/linear cm

Drug: Avotermin

6

PLACEBO COMPARATOR

Placebo matched to avotermin 200ng/100μL/linear cm

Drug: Placebo

7

EXPERIMENTAL

Avotermin 500ng/100μL/linear cm wound margin

Drug: Avotermin

8

PLACEBO COMPARATOR

Placebo matched to avotermin 500ng/100μL/linear cm

Drug: Placebo

Interventions

AvoterminDRUG

A single intradermal injection of avotermin administered at the dose to both margins of a full-thickness incision immediately following closure.

Also known as: Juvista, RN1001, transforming growth factor beta 3
1357
PlaceboDRUG

Matched to avotermin dosage strength

Also known as: None applicable
2468

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renovo Clinical Trials Unit

Manchester, M139XX, United Kingdom

Location

MeSH Terms

Conditions

CicatrixArrhythmogenic Right Ventricular Dysplasia, Familial, 1

Interventions

TGFB3 protein, humanTransforming Growth Factor beta3

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Transforming Growth Factor betaCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsTGF-beta Superfamily ProteinsProteinsBiological Factors

Study Officials

  • James Bush, MBChB

    Renovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 22, 2008

First Posted

March 3, 2008

Study Start

July 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

March 4, 2008

Record last verified: 2008-03

Locations

GB(1)