Clinical trial NCT00432211: Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.
Official title: A Double Blind, Placebo Controlled, Randomised Trial to Investigate the Efficacy of Juvista (Avotermin) in the Prevention or Improvement of Scar Appearance Following Scar Revision Surgery.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cicatrix
Lead sponsor: Renovo
Sponsor class: INDUSTRY
First posted: 2007-02-07
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Subjects aged 18-85 years who have provided written informed consent.
* A body mass index between 15 and 35 kg/m2 .
* Subjects with, in the opinion of the Investigator, clinically acceptable results for the laboratory tests specified in the trial protocol.
* Female subjects of child bearing potential who are using method(s) of contraception acceptable to the Investigator and agree to do so from at least the screening visit until one month after administration of the final study dose.
* Subjects with linear scars that, in the opinion of the Investigator, are suitable for revision by excision and direct closure. The area of scar to be revised must be at least 5cm in length and have at least two comparable areas.
* Subjects, who, in the opinion of the Investigator have stabilised, mature scars.

Exclusion Criteria:

* Subjects who on direct questioning and physical examination have history or evidence of keloid scarring.
* Subjects with scars for revision that cross a joint or are in close proximity to an anatomical structure, which could lead to distortion of the resultant scar.
* Subjects with additional scars less than 3cm away from the area to be revised.
* Subjects with a history of a bleeding disorder.
* Subjects with diseases or conditions that could, in the opinion of the Investigator, interfere with the assessment of safety, tolerability or efficacy.
* Subjects who have had surgery in the area to be excised within one year of Day 0.
* Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
* Subjects who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing.
* Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
* Subjects who are taking, or have taken, any investigational drugs including Juvista within 3 months prior to the screening visit.
* Subjects who are taking regular, continuous, oral corticosteroid therapy.
* Subjects who, in the opinion of the Investigator, have significant ongoing psychiatric disorders, which may interfere with the trial assessments / visits.
* Subjects undergoing investigations or changes in management for an existing medical condition.
* Subjects who are or who become pregnant up to and including Day 0 or who are lactating.
* In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.

Primary outcomes:
measure: Investigator scar assessment
timeFrame: up to 7 month visit
measure: Patient scar assessment
timeFrame: up to 7 month visit
measure: Independent scar assessment
timeFrame: up to month 7
Secondary outcomes:
measure: Local tolerability
timeFrame: up to month 7
measure: Adverse events
timeFrame: up to month 7
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Renovo Clinical Trials Unit
Study officials:
affiliation: University of Manchester
name: D A McGrouther, FRCS MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.