Investigation of the Accelerated Healing and Anti-scarring Potential of Avotermin (Juvista) in Split Skin Graft Donor Sites
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Single-site, Randomised, Double-blind, Phase II Trial to Investigate the Safety, Toleration, Systemic Exposure, Accelerated Healing and Anti-scarring Potential of Juvista in Split Skin Graft Donor Sites in Male Subjects Aged 18-85 Years|
- To assess the accelerated-healing potential of injection or injection plus topical application of Juvista in a male population undergoing minor split skin grafts (SSG) [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
- To assess the local safety and toleration of injection of Juvista or injection and topical application of Juvista at the SSG donor site in a healthy male population [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
- To assess systemic exposure following injection of Juvista or injection plus topical application of Juvista after SSG [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
- To assess the anti-scarring potential of injection or injection and topical application of Juvista in a male population [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2003|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
|Experimental: Intradermal Juvista||
Intradermal Juvista at 50ng/100μl/cm2 of SSG donor sites (3cm2) once just prior to wounding
|Placebo Comparator: Placebo||
Intradermal injection of Placebo at 100μl/cm2 of SSG donor site (3cm2) once just prior to wounding
|Experimental: Intradermal and topical Juvista||
Intradermal Juvista at 50ng/100μl/cm2 of SSG donor site once just prior to wounding, followed by topical Juvista at 100ng/200μl/cm2 after wounding and again at Day 1
|Placebo Comparator: Intradermal and topical placebo||
Intradermal placebo at 100μl/cm2 of SSG donor site once just prior to wounding, followed by topical placebo at 200μl/cm2 after wounding and again at Day 1
Subjects were allocated into three groups (Group 1, Group 2 and Group 3) with all subjects receiving two 3cm2 SSG donor sites, one to each side of the lower back. Before wounding on Day 0, each site was randomised to receive either an intradermal injection of Juvista (50ng/100μl/cm2), an intradermal injection of Placebo (100μl/cm2) or no injection (Standard Care). After wounding, subjects allocated to Group 2 and Group 3 also received topical Juvista (100ng/200μl/cm2), topical Placebo (200μl/cm2) or Standard Care (Tegaderm dressing only). Topical Juvista and Placebo were held within a Granuflex ring dressing and sealed with a sterile Tegaderm dressing.
On Day 1, subjects in Group 2 and Group 3 received a further topical application of Juvista, Placebo or Standard Care according to the same treatment randomisation as Day 0.
Punch biopsy samples of healing SSG donor sites were harvested from Group 3 subjects on Day 3, 5, 7 or 10, and preserved for histological analysis.
The final study visit for Group 3 subjects was the day of the biopsy visit. Subjects in Group 1 and Group 2 underwent scar assessments at the first follow-up at Month 1 and at Months 2, 3, 4, 5, 6, 9 and 12.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00984503
|Manchester, United Kingdom, M13 9XX|
|Principal Investigator:||Jonathan Duncan||Renovo|
|Principal Investigator:||Jeremy Bond||Renovo|
|Principal Investigator:||James Bush||Renovo|