ClinicalTrials.Veeva

Menu

A Trial to Compare the Efficacy of Two Formulations of Avotermin Against Placebo (RN1006)

R

Renovo

Status and phase

Completed
Phase 1

Conditions

Scar Improvement

Treatments

Drug: Placebo
Drug: RN1006 (Avotermin)
Drug: Juvista (Avotermin)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01029158
RN1006-0100

Details and patient eligibility

About

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

Enrollment

84 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

84 participants in 8 patient groups

1a
Experimental group
Description:
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.
Treatment:
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
Drug: Placebo
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
1b
Experimental group
Description:
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.
Treatment:
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)
Drug: Placebo
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)
1c
Experimental group
Description:
250 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
Treatment:
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)
Drug: Placebo
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)
1d
Experimental group
Description:
500 ng RN1006 or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
Treatment:
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)
Drug: Placebo
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)
2a
Experimental group
Description:
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.
Treatment:
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
Drug: Placebo
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
2b
Experimental group
Description:
500 ng Juvista or placebo injected intradermally down each 1 cm of wound margin immediately after wound closure.
Treatment:
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
Drug: Placebo
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
2c
Experimental group
Description:
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.
Treatment:
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
Drug: Placebo
Drug: Juvista (Avotermin)
Drug: Juvista (Avotermin)
2d
Experimental group
Description:
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).
Treatment:
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)
Drug: Placebo
Drug: RN1006 (Avotermin)
Drug: RN1006 (Avotermin)

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems