NCT00847795

Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.

A Trial to Investigate the Accelerated Wound Healing and Antiscarring Potential, Safety, Toleration and Systemic Exposure of Intradermal RN1001 (Avotermin) in Male and Female Subjects Aged 60 Years and Over.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Renovo · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject receives a total of 6 wounds, two incisions and four punch biopsies. Each subject serves as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing/scarring. Healed scars from incisional wounds excised from Arm 1 and Arm 2 after 6 months for histological analysis.

Conditions

• Cicatrix

Interventions

Type	Name	Description
DRUG	Avotermin	Intradermal administration
DRUG	Placebo	Placebo

Timeline

• Start date: 2002-09-01
• Primary completion: 2003-06-01
• Completion: 2003-06-01
• First posted: 2009-02-19
• Last updated: 2009-02-19

Locations

1 site across 1 country: United Kingdom