Safety and Efficacy Study of Avotermin (Juvista) in Female Subjects
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|