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This study is being undertaken to investigate the efficacy and safety of Juvista (given as an intradermal injection of 200ng/100µl per linear centimetre of wound margin) in the prevention or improvement of scar appearance when administered intradermally to approximated wound margins following surgical scar revision.
In addition, this study will compare the scar revision techniques of complete excision (excision of the entire scar during one surgical procedure) and staged excision (excision of the outmost segments and central core separately).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator | Complete Scar Excision |
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| 2 | Placebo Comparator | Staged Excision of scar |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avotermin | Drug | Complete Excision:- On Day 0,Following wound closure the two outer segments of the wound will receive either Juvista or placebo.100µl of vehicle containing 200ng of Juvista will be injected per linear centimetre into both margins of one segment of the wound,and 100µl of vehicle alone (placebo) will be injected per linear centimetre into the other segment of the wound. There will be a central area (at least 3cm) of untreated wound between the two segments.The treatments will be re-administered to each wound segment (A and B) 24 hours after the first administration. Staged Excision On Day 0, the two end segments of the scar will be excised.Following wound closure each subject will receive 100µl of vehicle containing 200ng of Juvista per linear centimetre intradermally into one wound, and 100µl of vehicle alone (placebo) per linear centimetre into the other wound.The trial treatments will be re-administered to each wound 24 hours after the first administration. |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator scar assessment | up to 7 month visit | |
| Patient scar assessment | up to 7 month visit | |
| Independent scar assessment | up to month 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Local tolerability | up to month 7 | |
| Adverse events | up to month 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| D A McGrouther, FRCS MD | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renovo Clinical Trials Unit | Manchester | M13 9XX | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21701333 | Derived | So K, McGrouther DA, Bush JA, Durani P, Taylor L, Skotny G, Mason T, Metcalfe A, O'Kane S, Ferguson MWJ. Avotermin for scar improvement following scar revision surgery: a randomized, double-blind, within-patient, placebo-controlled, phase II clinical trial. Plast Reconstr Surg. 2011 Jul;128(1):163-172. doi: 10.1097/PRS.0b013e318217429b. |
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| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C509044 | TGFB3 protein, human |
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