Efficacy and Safety of Intradermal RN1001 (Avotermin) in Elderly Subjects. - Full Text View

Sponsor:	Renovo
Information provided by:	Renovo
ClinicalTrials.gov Identifier:	NCT00847795

Purpose

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.

Condition	Intervention	Phase
Cicatrix	Drug: Avotermin Drug: Placebo	Phase 1 Phase 2

Study Type:	Interventional
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
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.

Resource links provided by NLM:

MedlinePlus related topics: Scars

U.S. FDA Resources

Further study details as provided by Renovo:

Primary Outcome Measures:

Evaluation of scar appearance by an independent panel [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Histological evaluation of wound healing [ Time Frame: 3 days ] [ Designated as safety issue: No ]
Adverse event occurance [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment:	42
Study Start Date:	September 2002
Study Completion Date:	June 2003
Primary Completion Date:	June 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 5ng Avotermin	Drug: Avotermin Intradermal administration Other Name: Juvista
Experimental: 2 50ng Avotermin	Drug: Avotermin Intradermal administration Other Name: Juvista
Experimental: 3 100ng Avotermin	Drug: Avotermin Intradermal administration Other Name: Juvista
Placebo Comparator: 4 Placebo	Drug: Placebo Placebo
No Intervention: 5 Standard Care

Detailed 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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847795

Locations

United Kingdom
Renovo CTU
Manchester, United Kingdom, M13 9XX

Sponsors and Collaborators

Renovo

Investigators

Principal Investigator:

Jonathan Duncan, BS BCh

Renovo

More Information

No publications provided by Renovo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ferguson MW, Duncan J, Bond J, Bush J, Durani P, So K, Taylor L, Chantrey J, Mason T, James G, Laverty H, Occleston NL, Sattar A, Ludlow A, O'Kane S. Prophylactic administration of avotermin for improvement of skin scarring: three double-blind, placebo-controlled, phase I/II studies. Lancet. 2009 Apr 11;373(9671):1264-74.

Responsible Party:	Mark Cooper, Renovo Ltd
ClinicalTrials.gov Identifier:	NCT00847795 History of Changes
Other Study ID Numbers:	RN1001-319-1005
Study First Received:	February 18, 2009
Last Updated:	February 18, 2009
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2012