Safety and Efficacy of RN1001(Avotermin) in Healthy Male Subjects - Full Text View

Sponsor:	Renovo
Information provided by:	Renovo
ClinicalTrials.gov Identifier:	NCT00847925

Purpose

A double blind, Placebo (Vehicle) and Standard Care controlled, randomised study to investigate the clinical safety and toleration (including systemic pharmacokinetics), wound healing and antiscarring potential of two applications of intradermal RN1001 in healthy male subjects

Condition	Intervention	Phase
Cicatrix	Drug: Avotermin (RN1001)	Phase I Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Double Blind, Placebo and Standard Care Controlled, Randomised Study to Investigate the Clinical Safety and Toleration, Wound Healing and Antiscarring Potential of Two Applications of Intradermal RN1001 (Avotermin) in Healthy Male Subjects

Resource links provided by NLM:

MedlinePlus related topics: Scars

Drug Information available for: Avotermin

U.S. FDA Resources

Further study details as provided by Renovo:

Primary Outcome Measures:

Scar severity [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Treatment local and systemic tolerance [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]

Enrollment:	103
Study Start Date:	November 2001
Study Completion Date:	September 2003
Primary Completion Date:	September 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A 50ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
B 20ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
C 5ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
D 100ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
E 500ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
F 0.25ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
G 1ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
H 20ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later
I 50ng Avotermin/100ul	Drug: Avotermin (RN1001) 100ul/linear cm of wound. Dosed before surgery and 24h later

Detailed Description:

Double blind, randomised, Placebo and Standard Care controlled, single centre study. Each subject served 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 and subsequent scarring. Subjects were initially dosed and wounded (incisions and punch biopsies) on Day 0 and re-dosed on Day 1. On Day 3, Arm 1 incisions and punch biopsies were re-dosed as per Day 0 and excised, and re-dosed again on Day 4. Arm 2 punch biopsies were excised at Day 5 but not re-dosed. Healed incisions/scars on Arm 2 were excised for histological analysis after 12 months and not re-dosed. All subjects, regardless of treatment were treated according to best practices for moist wound healing.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, non-Afro-Caribbean, male subjects aged 18-45 years inclusive.
Weight between 60 and 150kg and a body mass index between 15 - 55 kg/m2.
Subjects who have a previous history of surgery or minor injury and who have not developed any evidence of hypertrophic or keloid scar formation

Exclusion Criteria:

Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring.
Afro-Caribbean subjects are excluded because of the increased susceptibility to hypertrophic and keloid scarring.
Subjects with tattoos or previous scars in the areas to be biopsied.
Subjects, who on direct questioning and physical examination, have evidence of any past or present clinically significant disease and particularly coagulation disorders, immuno mediated conditions and skin diseases and allergies, such as eczema.
Subjects with a history of clinically significant allergies, especially drug hypersensitivity to lignocaine or allergy to the surgical dressings to be used in this study.
Subjects with any clinically significant abnormality following review of pre study laboratory data and full physical examination.
Subjects who are taking, or have taken, certain prescribed or investigational drug in the three weeks prior to Day 0 and in particular topical or systemic steroids, and anti-coagulant drugs. Certain drugs are not excluded in this trial. These include OTC analgesics including paracetamol and codeine, vitamin and mineral supplements, inhaled salbutamol, thyroxine replacement therapy, OTC cold remedies.
Subjects who drink more than 28 units of alcohol per week (1 unit = ½ pint of beer (285mls) or 25ml of spirits or 1 glass of wine).
Subjects who have current 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 study for what ever reason.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00847925

Locations

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

Sponsors and Collaborators

Renovo

Investigators

Principal Investigator:

Jonathan Duncan, MB BCh

Renovo

More Information

No publications provided by Renovo

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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:	Renovo ( Mark Cooper )
Study ID Numbers:	RN1001-309-1002
Study First Received:	February 17, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00847925 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Skin Diseases
Cicatrix

ClinicalTrials.gov processed this record on November 20, 2009