A Double Blind, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Subjects Undergoing Excision of Benign Head and Neck Naevi.
18 Years
85 Years
Both
Nevus, Cicatrix
Trial Information
A Double Blind, Placebo Controlled Randomised Trial to Investigate the Scar Improvement Efficacy of a Single Intradermal Application of RN1001 (Avotermin) in Subjects Undergoing Excision of Benign Head and Neck Naevi.
Male and female subjects (aged between 18-85 years) with one or more benign head & neck
naevi will be invited to participate in the study.
Each patient will be randomised to a particular dose group, depending on the number of
naevi suitable for excision. For example, patients with one excised naevi will receive
either a dose of one of the concentrations of RN1001, or placebo. A patient with 2 excised
naevi will receive an active dose, and placebo. Patients with 3 excised naevi will receive 2
active doses, plus placebo, and patient with four excised naevi will receive 3 active doses
plus placebo.
Naevi will be excised using punch biopsy, and then closed with standard sutures. Following
wound closure, the study drug (active RN1001 or placebo) will be administered via
intradermal injection at a rate of 100ul per linear cm of wound margin.
Digital and film photography will be taken pre-dose and post dose (Day 0, day 14, day 28,
Month 2, 3, 6 & 12, and thereafter at M24, M36, M48 & M60). Additionally, scar assessments
(completed by Investigator, Research Nurse & Medical photographer) will be completed at
follow up visits from Day 20 onwards. Silicone moulds of the scars will be taken at M6, M12
and then annually to M60.
Patients will be requested to complete a questionnaire to rate their scar
expectations/assessment on a total of 5 occasions (screening, Day 0, Month 3, Month 6 &
Month 12)
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Month 12 VAs - difference between active and placebo
Outcome Time Frame:
12 month
Safety Issue:
No
Principal Investigator
Jim Bush, MB ChB
Investigator Role:
Principal Investigator
Investigator Affiliation:
Renovo Clinical Trials Unit
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
RN1001-319-1008
NCT ID:
NCT00656227
Start Date:
April 2004
Completion Date:
July 2012
Related Keywords:
- Nevus
- Cicatrix
- Nevus
- Nevus, Pigmented
- Cicatrix
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