Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-03-12 @ 11:11 AM
Study NCT ID:
NCT00984516
Status:
COMPLETED
Last Update Posted:
2009-09-25
First Post:
2009-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation Into the Safety and Scar-improvement Efficacy of Intradermal Juvidex Dosed Once or Three Times
Sponsor:
Renovo
Organization:
Study Overview
Official Title:
A Single-site, Placebo-controlled, Double-blind Trial to Investigate the Safety, Tolerability, Systemic Exposure and the Scar-improvement Efficacy of Intradermal Applications of Three Doses of Juvidex (5.64mg/100μl, 2.82mg/100μl and 11.28mg/100μl) Given Once Only or Three Times Within and Between Male and Female Subjects Aged 18-45.
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study was to investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only or three times in male and female subjects and to collect further safety and tolerability data for intradermal Juvidex in male and female subjects.
Detailed Description:
Subjects were randomised into three dose groups of equal size. The three dose groups were 100mM (2.82mg/100μl), 200mM (5.64mg/100μl) and 400mM (11.28mg/100μl). Before wounding, three prospective wound sites 1cm long were marked on the upper, inner aspect of each arm (anterior, posterior and distal) to give three pairs of wounds. Wounds were assigned as Pair 1 (left distal and right distal), Pair 2 (left anterior and left posterior) and Pair 3 (right anterior and right posterior).
Sites were anaesthetised using 1% plain lignocaine, then prior to wounding one site from each pair, randomly assigned, received an intradermal injection of Juvidex (100μl) and the opposite site from each pair received an intradermal injection of Placebo (100μl).
Within dose groups, subjects were randomised into two subgroups of similar size. Subgroup A received one dose in wound pairs 1 and 2; and three doses in wound pair 3. Subgroup B received three doses in wound pairs 1 and 2; and one dose in wound pair 3. Incision sites randomised to receive three injections of study medication were re-dosed with 100μl per wound margin (200μl per site) 3 hours after receiving the first dose and dosed again in the same way on Day 5.
Subjects attended a follow-up visit on Day 14. Scars were assessed monthly from Month 1 to Month 12. At Month 12, the Investigator excised the distal scars from each subject for histological examination. Posttrial follow-up visits are scheduled for Months 18 and 24.
Sites were anaesthetised using 1% plain lignocaine, then prior to wounding one site from each pair, randomly assigned, received an intradermal injection of Juvidex (100μl) and the opposite site from each pair received an intradermal injection of Placebo (100μl).
Within dose groups, subjects were randomised into two subgroups of similar size. Subgroup A received one dose in wound pairs 1 and 2; and three doses in wound pair 3. Subgroup B received three doses in wound pairs 1 and 2; and one dose in wound pair 3. Incision sites randomised to receive three injections of study medication were re-dosed with 100μl per wound margin (200μl per site) 3 hours after receiving the first dose and dosed again in the same way on Day 5.
Subjects attended a follow-up visit on Day 14. Scars were assessed monthly from Month 1 to Month 12. At Month 12, the Investigator excised the distal scars from each subject for histological examination. Posttrial follow-up visits are scheduled for Months 18 and 24.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: