CompletedPhase 1

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

United Kingdom84 participantsStarted 2009-08

Plain-language 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

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Global scar comparison scale

Timeframe: 12 months

Trial details

NCT IDNCT01029158

SponsorRenovo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-09

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