A Trial to Investigate Scar Improvement Efficacy of RN1001 (Avotermin) After Head and Neck Naevi Excision

• Status: Unknown status
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Renovo

Criteria

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.