A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo

Phase 1

Completed

• Conditions: Scar Improvement
• Interventions: Drug: Juvista (Avotermin); Drug: RN1006 (Avotermin); Drug: Placebo

• Registration Number: NCT01029158
• Lead Sponsor: Renovo

Brief Summary

RN1006 has been developed as a stabilized formulation of avotermin which, when dosed once in pre-clinical studies in animals, has shown comparable scar improvement efficacy to the standard twice-dosed Juvista formulation. The aim of this trial is to investigate the efficacy of RN1006 compared to Juvista in a human volunteer model

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-07
• Study First Posted: 2009-12-09
• Primary Completion: 2010-09
• Study Completion: 2010-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-07
• Last Update Posted: 2010-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• Males and females aged 18-85 years who have given written informed consent
• Subjects with a body mass index within range 18-35 kg/m2
• Subjects with clinically acceptable results for the laboratory tests specified in the trial protocol
• Female subjects using a highly effective method (S) of contraception

Exclusion Criteria

• Subjects who have a history of keloid scarring, surgery within one year of the first dosing area
• Subjects who have current scars, tattoos, birthmarks, mole within 3 cm of the area to be excised
• Subjects with any clinically significant medical condition or history of any condition which may impair wound healing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2a	Juvista (Avotermin)	250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
1a	Juvista (Avotermin)	250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
1a	Placebo	250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
1b	RN1006 (Avotermin)	250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
1b	Placebo	250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
1c	RN1006 (Avotermin)	250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
1c	Placebo	250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
1d	RN1006 (Avotermin)	500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
1d	Placebo	500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
2a	Placebo	250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 250 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
2b	Juvista (Avotermin)	500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
2b	Placebo	500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
2c	Juvista (Avotermin)	500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
2c	Placebo	500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then a further 500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose.
2d	RN1006 (Avotermin)	500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total).
2d	Placebo	500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure. Then 500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin 24 (+/- 4) hours after administration of the first dose (i.e. two doses in total).

Primary Outcome Measures

Name	Time	Method
Global scar comparison scale	12 months

Secondary Outcome Measures

Name	Time	Method
Adverse event incidence including specific assessment of local tolerability at the treated wound site	12 months

Trial Locations

Locations (1)

Renovo CTU; 🇬🇧 Manchester, United Kingdom