Investigation Into the Scar Reduction Potential of Prevascar (Interleukin-10)

NCT00984646 | Completed Phase 2

• 1 other identifier: RN1003-0027
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to investigate the scar-reducing properties of eight doses of intradermal Prevascar (IL-10).

Conditions

Cicatrix; Wound Healing

Keywords

Cicatrix; Scar; Wound-healing; Prevascar; Interleukin-10 (IL-10); Ilodecakin; RN1003

Outcome Measures

Primary Outcomes (1)

• To establish which of eight intradermal doses of RN1003 has the greatest scar-reducing properties, compared with Placebo and Standard Care.

  12 months

Secondary Outcomes (2)

• To collect further safety and tolerability data for RN1003

  12 months

• To assess pre- and post-dose systemic levels of RN1003.

  12 months

Study Arms (2)

Intradermal Prevascar

EXPERIMENTAL

Drug: Prevascar

Placebo (vehicle)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Prevascar DRUG

Intradermal Prevascar, 5ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Also known as: IL-10, Ilodecakin, RN1003

Intradermal Prevascar

Placebo DRUG

Intradermal Placebo, 100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Placebo (vehicle)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, aged 18-85 years, who have given written informed consent
• Subjects with a BMI (Quetelet's index) within the permitted weight/height2 range of 15-55kg/m2
• Subjects with, in the opinion of the Investigator, clinically acceptable results for screening laboratory tests performed within 28 days prior to the first trial administration
• Female subjects with child-bearing potential who are using a method(s) of contraception deemed acceptable by the Investigator and agree to continue doing so for the first month of the trial

You may not qualify if:

• Subjects who, on direct questioning and by physical examination, reveal a history or evidence of hypertrophic or keloid scarring
• Subjects with tattoos or previous scars within 3cm of the area to be incised during the trial
• Subjects of Afro-Caribbean descent, because of their increased susceptibility to hypertrophic or keloid scarring
• Subjects who have had previous surgery in the area to be incised, conducted within 1 year of the first dosing day
• Subjects with a history of a bleeding disorder or who are receiving anticoagulant therapy
• Subjects who, on direct questioning and physical examination, show evidence of any past or present clinically significant disease that may affect the endpoints of the trial, e.g. coagulation disorders, diabetes, immuno- mediated conditions and clinically significant skin diseases or allergies
• 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 or involves the areas to be examined in this trial
• Subjects with any clinically significant medical condition or history that would impair wound healing, including significant rheumatoid arthritis, chronic renal impairment (significant for age), significant hepatic impairment (liver function tests \>3 times upper limit of normal), congestive heart failure, active malignancy or history of malignancy within last 5 years, immunosuppression or chemotherapy within last 12 months, history of radiotherapy or diabetes mellitus
• Subjects with a history of hypersensitivity to any of the drugs or dressings used in the trial
• Subjects who are taking, or who have taken, any investigational product or participated in a clinical trial within 3 months prior to the 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 who test positive for drugs of abuse (cocaine, amphetamines, methamphetamines, opiates or benzodiazepines) during the screening period, which is not explained by the intake of legitimate prescribed or over-the-counter medication for a documented medical condition
• Subjects who, in the opinion of the Investigator, are unlikely to complete the trial for whatever reason

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo

Manchester, M13 9XX, United Kingdom

Location

Related Publications (1)

• Do NN, Willenborg S, Eckes B, Jungst C, Sengle G, Zaucke F, Eming SA. Myeloid Cell-Restricted STAT3 Signaling Controls a Cell-Autonomous Antifibrotic Repair Program. J Immunol. 2018 Jul 15;201(2):663-674. doi: 10.4049/jimmunol.1701791. Epub 2018 Jun 13.

  PMID: 29898959 DERIVED

MeSH Terms

Conditions

Cicatrix

Interventions

Interleukin-10

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• James Bush

  Renovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 25, 2009
• Study Start: April 1, 2005
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: September 25, 2009

Record last verified: 2009-09

Locations

GB (1)