Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects.

Cicatrix Clinical Trial

Official title:

A Trial to Investigate the Accelerated Wound Healing and Antiscarring Potential, Safety, Toleration and Systemic Exposure of Intradermal RN1001 (Avotermin) in Male and Female Subjects Aged 60 Years and Over.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00847795
• Other study ID #: RN1001-319-1005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: February 18, 2009
• Last updated: February 18, 2009
• Start date: September 2002
• Est. completion date: June 2003

Study information

• Verified date: February 2009
• Source: Renovo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

An exploratory Phase-II trial with intradermal RN1001 (Avotermin) to investigate scar prevention and reduction and acceleration of healing. The trial has an additional objective to evaluate several different scar assessment techniques that can be used in future clinical trials in the prevention and reduction of scarring.

Description:

Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject receives a total of 6 wounds, two incisions and four punch biopsies. Each subject serves as their own control, i.e. Arm 1 incisions/biopsies randomly received one of two treatments and Arm 2 incisions/biopsies received the same treatments as for Arm 1 but in reverse. The randomisation of the treatment allowed for control of possible positional effects on healing/scarring. Healed scars from incisional wounds excised from Arm 1 and Arm 2 after 6 months for histological analysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Clinically healthy, male and female subjects aged 60 years and over. All females will be at least 2 years post menopausal.

• Weight between 50 and 150kg or a body mass index within the permitted range for their height using Quetelet's index-weight (kg)/height²(m). The permitted index is between 15 - 35 kg/m2.

Exclusion Criteria:

• Subjects who on direct questioning and physical examination have a history or evidence of hypertrophic or keloid scarring or with tattoos or previous scars in the area to be biopsied.

• Subjects with a personal history of a bleeding disorder.

• Subjects with a skin disorder that is chronic or currently active and which the investigator considers will adversely affect the healing the acute wounds or involves the areas to be examined in this trial.

• Subjects with any clinically significant medical condition that would impair wound healing including renal, hepatic, haematological, neurological or immune disease.

• Subjects with a history of clinically significant drug hypersensitivity to lignocaine or allergy to surgical dressings to be used in this trial.

• Subjects with any clinically significant abnormality following review of pre trial laboratory data and physical examination (see above).

• Subjects who are taking, or have taken, any investigational drugs, long term oral, topical or inhaled corticosteroid therapy, hormone replacement therapy (HRT) or anti-coagulant drugs in the thirty days prior to Day 0.

• Subjects who have evidence of drug abuse.

• Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B surface antigen or hepatitis C antibody. Subjects with previous vaccination against Hepatitis B are not excluded per se.

• Subjects who are known to have or had serum hepatitis or who are carriers of the hepatitis B core antibody and who show less than 10 units per litre of Anti-HBs.

• Subjects who have previously had a positive result to the test for HIV antibodies, or who admit to belonging to a high-risk group.

• In the opinion of the investigator, a subject who is not likely to complete the trial for what ever reason.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cicatrix

Intervention

Drug:
• Avotermin
Intradermal administration
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	Renovo CTU	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Renovo

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of scar appearance by an independent panel		6 months	No
Secondary	Histological evaluation of wound healing		3 days	No
Secondary	Adverse event occurance		6 months	Yes