Investigation Into the Safety and Scar-improvement Efficacy of Intradermal Juvidex Dosed Once or Three Times

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.

Conditions

• Cicatrix
• Wound-healing

Interventions

DRUG

Juvidex

Intradermal Juvidex, 100μl of 100mM (2.82mg/100μl) administered once prior to wounding

DRUG

Juvidex

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)

DRUG

Juvidex

Intradermal Juvidex, 100μl of 200mM (5.64mg/100μl) administered once prior to wounding

DRUG

Juvidex

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)

DRUG

Juvidex

Intradermal Juvidex, 100μl of 400mM (11.28mg/100μl) administered once prior to wounding

DRUG

Juvidex

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)

DRUG

Placebo

Intradermal Placebo, 100μl administered once prior to wounding

DRUG

Placebo

Intradermal Placebo, 100μl administered once prior to wounding, once 3 hours later at 100μl/wound margin (200μl total) and again on Day 5 (200μl)

Sponsors & Collaborators

• Renovo

  lead INDUSTRY

Principal Investigators

• James Bush · Renovo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2004-08-31

Primary Completion

2006-01-31

Completion

2006-01-31

Countries

• United Kingdom

Study Locations