Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects
|ClinicalTrials.gov Identifier: NCT00984581|
Recruitment Status : Completed
First Posted : September 25, 2009
Last Update Posted : September 25, 2009
|Condition or disease||Intervention/treatment||Phase|
|Cicatrix Wound Healing||Drug: Avotermin Drug: Placebo||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||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|
|Study Start Date :||April 2003|
|Actual Primary Completion Date :||August 2004|
|Actual Study Completion Date :||August 2004|
|Experimental: Intradermal avotermin||
Intradermal injection, 5ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
Intradermal injection, 50ng/100ul/linear cm wound margin administered on Day 0, Day 1 and month 6
|Placebo Comparator: Placebo||
Intradermal injection, 100ul/linear cm wound margin administered on Day 0 and Day 1
- To collect safety and tolerability data for intradermal injection of Juvista in a young female subject group. [ Time Frame: Month 6 ]
- To assess systemic exposure following intradermal Juvista before and after minor skin incisions. [ Time Frame: Month 6 ]
- To assess the anti-scarring potential of intradermal Juvista in a young female population. [ Time Frame: Month 6-12 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984581
|Manchester, United Kingdom, M13 9XX|
|Principal Investigator:||Jonathan Duncan||Renovo|
|Principal Investigator:||Jeremy Bond||Renovo|