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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Renovo

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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