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

NCT00984516 | Completed Phase 2

• 1 other identifier: RN1004-319-1002
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix; Wound-healing

Keywords

Cicatrix; Scar; Wound-healing; Juvidex; Mannose-6-phosphate; M6P; RN1004

Outcome Measures

Primary Outcomes (1)

• To investigate the scar-improvement efficacy of three doses of intradermal Juvidex given once only and three times in male and female subjects.

  12 months

Secondary Outcomes (2)

• To collect further safety and tolerability data for various doses and dosing frequencies of intradermal Juvidex in male and female subjects.

  1 hour to 24 months

• To assess systemic exposure to Juvidex, following various doses and dosing frequencies of intradermal Juvidex, before and after making minor skin incisions in male and female subjects.

  1 hour to 12 months

Study Arms (2)

Intradermal Juvidex

EXPERIMENTAL

Drug: Juvidex

Placebo (vehicle)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Juvidex DRUG

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

Also known as: Mannose-6-phosphate, M6P, RN1004

Intradermal Juvidex

Placebo DRUG

Intradermal Placebo, 100μl administered once prior to wounding

Placebo (vehicle)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects aged 18-45 years who gave written informed consent
• Weight between 50-150kg with a BMI within the permitted range for their height using Quetelet's index: weight (kg)/height (m)2. The permitted range was 15-55kg/m2
• Female subjects of childbearing potential who were deemed by the Investigator to be using adequate contraception at the time of screening and who agreed to continue using this form of contraception for the duration of the trial
• In the opinion of the Investigator, and on the basis of the investigations carried out within 12 weeks prior to the first study drug dose (determined by results of electrocardiogram \[ECG\], physical examination, medical history, haematology and biochemistry blood results) the subject was in adequate health to undertake the trial

You may not qualify if:

• Subjects who on direct questioning and physical examination had a history or evidence of hypertrophic or keloid scarring or had tattoos in the area to be incised
• Afro-Caribbean subjects because of their increased susceptibility to hypertrophic and keloid scarring
• Subjects who had surgery in the area to be incised within one year of the first dosing day
• Subjects with a history of a bleeding disorder
• Subjects who, on direct questioning and physical examination, had evidence of any past or present clinically significant disease, particularly coagulation disorders, diabetes, immuno-mediated conditions and skin diseases and allergies, such as clinically significant eczema
• Subjects with a skin disorder that was chronic or currently active and which the Investigator considered would adversely affect the healing of the acute wounds or would involve the areas to be examined in this trial
• Subjects with any clinically significant medical condition that would impair wound healing including; significant rheumatoid arthritis, chronic renal impairment significant for their age, significant hepatic impairment (LFTs \>3 times upper limit of normal), congestive heart failure, current active malignancy or history of malignancy in the last 5 years, immunosuppression or chemotherapy within the last 12 months, a history of radiotherapy and diabetes mellitus
• Subjects with a history of clinically significant drug hypersensitivity to lignocaine or an allergy to surgical dressings to be used in this trial
• Subjects who were taking or had taken any investigational product or participated in a clinical trial within the three months prior to first study drug dose for this trial
• Subjects who were taking regular, continuous, oral corticosteroid therapy
• Subjects who, in the opinion of the Investigator, were not likely to complete the trial for whatever reason
• Subjects who were, or who became, pregnant or were lactating, up to and including the time of the first dose of study drug
• Subjects undergoing/awaiting investigations or change in management for an existing medical disorder
• Subjects who had evidence of drug abuse

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo

Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Interventions

mannose-6-phosphate

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Bush

  Renovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: August 1, 2004
• Primary Completion: January 1, 2006
• Study Completion: January 1, 2006
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

GB (1)