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A single centre, placebo and standard care controlled, double blind, randomised, trial to investigate the efficacy of eight doses of RN1003 in the reduction of scarring from approximated wound margins of incisional wounds - RN1002 - 0027

A single centre, placebo and standard care controlled, double blind, randomised, trial to investigate the efficacy of eight doses of RN1003 in the reduction of scarring from approximated wound margins of incisional wounds - RN1002 - 0027

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-001455-11-GB
Enrollment
175
Registered
2005-02-23
Start date
2006-04-03
Completion date
Unknown
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention and reduction of scarring MedDRA version: 6.1 Level: PT Classification code 10039580

Interventions

Product Name: RN1003 Product Code: RN1003 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Not allocated CAS
IL-10
rhu-IL10 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: range Concentration number: 0.05-2 Pharmaceutical form of

Sponsors

Renovo Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (i) Male and female subjects aged 18-85 years who have given written informed consent. (ii) Subjects with a body mass index within 15-55kg per square metre (iii) Subjects with, in the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the protocol. (iv) Female subjects of child bearing potential must be using method(s) of contraception acceptable to the investigator and agree to continue doing so for the first month of the trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: (i) Subjects with a clinically significant skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds. (ii) Subjects with any clinically significant medical condition or history that wound impair wound healing (iii) Subjects who on direct questioning and physical examination have history or evidence of hypertrophic or keloid scarring (iv) Subjects with tattoos or previous scars witih 3cm of the area to be incised during the trial. (v) Afro-Carribean subjects

Design outcomes

Primary

MeasureTime frame
Main Objective: To establish which of the eight doses of RN1001 has the greatest scar reducing properties, as compared to placebo and standard care.; Secondary Objective: To collect pre and post dose systemic levels of RN1003 To collect further safety and tolerability data for RN1003 ;Primary end point(s): Primary trial endpoint is the external scar assessment panel VAS scores for photographs of scars at the 12 month visit.—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026