NCT00984581

Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects

A Single-site, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and Anti-scarring Potential of Intradermal Juvista in Female Subjects Aged 18-45 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Renovo · Industry
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To assess safety and toleration, systemic exposure and anti-scarring potential of intradermal avotermin (Juvista) in young females.

Detailed description

Subjects were to receive two 1cm incisions on the upper, inner aspect of each arm (four wounds per subject). On Day 0 all subjects received intradermal Juvista at a concentration of 50ng/100ul to one incision site on Arm 1 and 5ng/100ul to one incision site on Arm 2. The other incision sites were injected with placebo. Following injection, 1cm incision wounds were made at each site. On Day 1 all subjects were re-injected with 100ul/cm intradermal Juvista or placebo to each side of the wound (200ul per incision) at the same concentration as for Day 0 (50 or 5ng/100ul). At month 6 all incision sites were excised for histological analysis and all excision sites injected with Juvista. Both sites on Arm 1 received 50ng/100ul/linear cm wound margin and both sites on Arm 2 received 5ng/100ul/linear cm wound margin. No excision sites received placebo. The appearance of excision scars was then assessed after 2, 4 and 6 months of healing i.e at months 8, 10 and 12 of the study.

Conditions

• Cicatrix
• Wound Healing

Interventions

Type	Name	Description
DRUG	Avotermin	Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
DRUG	Avotermin	Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
DRUG	Placebo	Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1

Timeline

• Start date: 2003-04-01
• Primary completion: 2004-08-01
• Completion: 2004-08-01
• First posted: 2009-09-25
• Last updated: 2009-09-25

Locations

1 site across 1 country: United Kingdom