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

NCT ID: NCT00984646

Last Updated: 2009-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 175 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2006-11-30

Brief Summary

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

Detailed Description

Subjects were randomised to one of two dose groups, each with four concentrations of intradermal Prevascar. Subjects had four 1cm incisional wounds made on the inner aspect of each upper arm (eight in total), giving four sets of anatomically paired wound sites per subject. Each subject acted as their own control with one site from each wound pair randomly treated with intradermal Prevascar and the other treated with Placebo (vehicle) or Standard Care.

Intradermal Prevascar was administered at 100μl per linear cm of wound site prior to wounding on Day 0 and 100μl per linear cm to each wound margin 24 hours later on Day 1. Group 1 subjects received doses of 5, 50, 250 and 1000ng/100μl and group 2 subjects received 25, 125, 500 and 2000ng/100μl.

Subjects in each group were also randomised into two control subgroups to receive either 100μl/linear cm intradermal placebo (Subgroup 1) or Standard Care alone (Subgroup 2) at control wound sites.

Subjects returned for follow-up at Day 14, Month 1, Month 3, Month 6, Month 9 and Month 12.

Conditions

Cicatrix; Wound Healing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intradermal Prevascar

Group Type: EXPERIMENTAL

Prevascar

Intervention Type: DRUG

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

Prevascar

Intervention Type: DRUG

Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Prevascar

Intervention Type: DRUG

Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Prevascar

Intervention Type: DRUG

Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Prevascar

Intervention Type: DRUG

Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Prevascar

Intervention Type: DRUG

Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Prevascar

Intervention Type: DRUG

Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Prevascar

Intervention Type: DRUG

Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Placebo (vehicle)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Prevascar

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

Intervention Type: DRUG

Prevascar

Intradermal Prevascar, 50ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Intervention Type: DRUG

Prevascar

Intradermal Prevascar, 250ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Intervention Type: DRUG

Prevascar

Intradermal Prevascar, 1000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Intervention Type: DRUG

Prevascar

Intradermal Prevascar, 25ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Intervention Type: DRUG

Prevascar

Intradermal Prevascar, 125ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Intervention Type: DRUG

Prevascar

Intradermal Prevascar, 500ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Intervention Type: DRUG

Prevascar

Intradermal Prevascar, 2000ng/100μl/linear cm of wound site or margin administered once just prior to wounding and once 24 h later

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003; IL-10; Ilodecakin; RN1003

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Subjects receiving immunosuppressive treatment
• Females who are pregnant or lactating
• Subjects who have any clinically significant neurological impairment or disease
• Subjects with an active infection (subjects were able to participate in the trial once the infection had passed and they had been re-screened)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Renovo

INDUSTRY

Sponsor Role: lead

Responsible Party

Renovo

Principal Investigators

James Bush

Role: PRINCIPAL_INVESTIGATOR

Renovo

Locations

Renovo

Manchester, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29898959 (View on PubMed)

Other Identifiers

RN1003-0027

Identifier Type: -

Identifier Source: org_study_id