Scar-Improvement Efficacy and Safety of a Single Intradermal Injection of Avotermin (Juvista) Administered Following Full-Thickness Skin Incisions

Renovo

Status and phase: Completed; Phase 2

Conditions: Cicatrix

Treatments: Drug: Avotermin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627536

RN1001-0050

Details and patient eligibility

About

This study was undertaken to investigate the scar-improvement efficacy and safety of a single dose of avotermin (Juvista) injection into skin incisions.

Enrollment: 39 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females aged 18-85 years who had given written informed consent.
• Subjects with a body mass index within 15 to 35 kg/m2.
• Subjects with clinically acceptable results for the laboratory tests
• Female subjects of child bearing potential who are using acceptable method(s) of contraception.

Exclusion criteria

• Subjects with history or evidence of hypertrophic or keloid scarring.
• Subjects with tattoos or previous scars within 3cm of the area to be incised.
• Subjects with prior surgery in the area to be incised within one year of the first dosing day.
• Subjects with a history of a bleeding disorder; receiving anti-coagulant or anti-platelet therapy.
• Subjects with evidence of any past or present clinically significant disease that may affect the endpoints of the trial.
• Subjects with a clinically significant skin disorder that is chronic or currently active.
• Subjects with any clinically significant medical condition or history that would impair wound healing.
• Subjects with a history of drug hypersensitivity to any of the drugs or dressings used in this trial.
• Subjects who are taking, or have taken any investigational product or participated in a clinical trial in the three months prior to first trial dose administration.
• Subjects who are taking regular, continuous, oral corticosteroid therapy.
• Subjects undergoing investigations or changes in management for an existing medical condition.
• Subjects with a history of drug abuse, or with a positive drugs of abuse test for cocaine, amphetamines, metamphetamines, opiates or benzodiazepines during the screening period.
• Subjects who are considered unlikely to complete the trial for whatever reason.
• Subjects with a clinically significant neurological impairment or disease.
• Subjects with any active infection.
• Subjects who are pregnant or lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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39 participants in 8 patient groups, including a placebo group

1

Experimental group

Description:

Avotermin 5ng/100μL/linear cm wound margin

Treatment:

Drug: Avotermin

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

3

Experimental group

Description:

Avotermin 50ng/100μL/linear cm wound margin

Treatment:

Drug: Avotermin

4

Placebo Comparator group

Description:

Placebo matched to avotermin 50ng/100μL/linear cm

Treatment:

Drug: Placebo

5

Experimental group

Description:

Avotermin 200ng/100μL/linear cm

Treatment:

Drug: Avotermin

6

Placebo Comparator group

Description:

Placebo matched to avotermin 200ng/100μL/linear cm

Treatment:

Drug: Placebo

7

Experimental group

Description:

Avotermin 500ng/100μL/linear cm wound margin

Treatment:

Drug: Avotermin

8

Placebo Comparator group

Description:

Placebo matched to avotermin 500ng/100μL/linear cm

Treatment:

Drug: Placebo