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NCT00984516

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.

Completed Phase 2 Last updated 24 September 2009
What this trial tests

Phase 2 trial testing Juvidex in Cicatrix in 102 participants. Completed in 1 January 2006.

Timeline
1 August 2004
Primary endpoint
1 January 2006
1 January 2006

Quick facts

Lead sponsorRenovo
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment102
Start date1 August 2004
Primary completion1 January 2006
Estimated completion1 January 2006
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Renovo — full company profile →

Who can join

Adults 18 to 45, any sex, with Cicatrix or Wound-healing. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New molecular medicine-based scar management strategies.
    Arno AI, Gauglitz GG, Barret JP, Jeschke MG. · · 2014 · cited 32× · PMID 24438742 · DOI 10.1016/j.burns.2013.11.010
  2. Novel pharmacotherapy for burn wounds: what are the advancements.
    Hamblin MR. · · 2019 · cited 17× · PMID 30517046 · DOI 10.1080/14656566.2018.1551880

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Other recruiting trials for Cicatrix

Currently open trials in the same condition.

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