NCT00847795

Brief Summary

An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar prevention and reduction and acceleration of healing. The trial has an additional objective to evaluate several different scar assessment techniques that can be used in future clinical trials in the prevention and reduction of scarring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2002

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

September 1, 2002

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
5.7 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
Last Updated

February 19, 2009

Status Verified

February 1, 2009

Enrollment Period

9 months

First QC Date

February 18, 2009

Last Update Submit

February 18, 2009

Conditions

Cicatrix

Outcome Measures

Primary Outcomes (1)

  • Evaluation of scar appearance by an independent panel

    6 months

Secondary Outcomes (2)

  • Histological evaluation of wound healing

    3 days

  • Adverse event occurance

    6 months

Study Arms (5)

1

EXPERIMENTAL

5ng Avotermin

Drug: Avotermin

2

EXPERIMENTAL

50ng Avotermin

Drug: Avotermin

3

EXPERIMENTAL

100ng Avotermin

Drug: Avotermin

4

PLACEBO COMPARATOR

Placebo

Drug: Placebo

5

NO INTERVENTION

Standard Care

Interventions

AvoterminDRUG

Intradermal administration

Also known as: Juvista
123
PlaceboDRUG

Placebo

4

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically healthy, male and female subjects aged 60 years and over. All females will be at least 2 years post menopausal.
  • Weight between 50 and 150kg or a body mass index within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 15 - 35 kg/m2.

You may not qualify if:

  • Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.
  • Subjects with a personal 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 the acute wounds or involves the areas to be examined in this trial.
  • Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.
  • Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.
  • Subjects with any clinically significant abnormality following review of pre trial laboratory data and physical examination (see above).
  • Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, hormone replacement therapy (HRT) or anti-coagulant drugs in the thirty days prior to Day 0.
  • Subjects who have evidence of drug abuse.
  • Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.
  • Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.
  • Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group.
  • In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renovo CTU

Manchester, M13 9XX, United Kingdom

Location

Related Publications (1)

  • Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74. doi: 10.1016/S0140-6736(09)60322-6.

    PMID: 19362676DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

TGFB3 protein, human

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jonathan Duncan, BS BCh

    Renovo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

September 1, 2002

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

February 19, 2009

Record last verified: 2009-02

Locations

GB(1)