Investigation Into the Safety and Scar-improvement Efficacy of Intradermal Juvidex Dosed Once or Three Times
Condition: Cicatrix; Wound-healing
MeSH terms: Cicatrix
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Juvidex; Juvidex; Juvidex; Juvidex; Juvidex; Juvidex; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding; Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl); Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding; Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl); Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding; Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl); Intradermal Placebo, 100μl administered once prior to wounding; Intradermal Placebo, 100μl administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)
Other intervention name(s): Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004; Mannose-6-phosphate; M6P; RN1004
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cicatrix; Scar; Wound-healing; Juvidex; Mannose-6-phosphate; M6P; RN1004