NCT00656227

Brief Summary

This trial will investigate whether four doses of RN1001 (20ng, 50ng, 100ng and 200ng) are efficacious in preventing or reducing the resultant scar, as compared to placebo, when applied intradermally to wound margins following excision of benign naevi situated on the head and neck.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2008

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 11, 2008

Status Verified

April 1, 2008

Enrollment Period

3.2 years

First QC Date

April 7, 2008

Last Update Submit

April 10, 2008

Conditions

NevusCicatrix

Outcome Measures

Primary Outcomes (1)

  • Month 12 VAs - difference between active and placebo

    12 month

Secondary Outcomes (1)

  • VAS from the independent external panel

    12 months

Interventions

AvoterminDRUG

Comparison of different dose levels (20ng, 50ng, 100ng or 200ng/100 ul) versus placebo

Eligibility Criteria

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

You may qualify if:

  • Weight between 50 and 150kg and a body mass index within the permitted range for their height, using Quetelet's index-weight (kg)/height² (m). The permitted index is between 15-55.
  • Subjects with one or more benign head and neck naevi which when measured are at least 3cm apart.
  • Subjects who are aged 18-85 years.

You may not qualify if:

  • Subjects who on examination have a naevus or naevi, which appear clinically suspicious of malignancy and therefore require specialist referral and treatment.
  • Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or tattoo(s) or previous scar(s) in the area to be excised.
  • 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 of 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.
  • Subjects who are taking, or have taken, any investigational drugs within the last 30 days, long term oral, topical or inhaled corticosteroid therapy and anti coagulant or anti platelet medication.
  • Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements and OTC cold remedies containing paracetamol as the active ingredient.
  • Subjects who are pregnant or who become pregnant up to and including Day 0. Subjects must use suitable forms of contraception during at least the first two months of the trial.
  • 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 whatever reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renovo Clinical Trials Unit

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

NevusCicatrix

Interventions

TGFB3 protein, human

Condition Hierarchy (Ancestors)

Nevi and MelanomasNeoplasms by Histologic TypeNeoplasmsFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jim Bush, MB ChB

    Renovo Clinical Trials Unit

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 11, 2008

Study Start

April 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2012

Last Updated

April 11, 2008

Record last verified: 2008-04

Locations

GB(1)