Prevascar in African Continental Group Scarring

NCT01115868 | Unknown Phase 1

• 1 other identifier: RN1003-0110
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

There is considerable variation in scarring, within and between people, and between different ethnic groups. Individuals with more pigmented skin are more prone to severe scarring than those traditionally termed white. Prevascar is being developed by Renovo for use as a potential treatment for reducing scarring. Renovo's histological analysis of wounds and scars in human non drug studies demonstrates an increase in wound and scar width in subjects of African Caribbean ancestry over a 12 month period. It is hypothesised that IL-10 may be a potentially beneficial therapy for the reduction of scarring in Non Caucasians of African-Caribbean ancestry. This Renovo clinical trial will be carried out primarily to establish the effects of four doses of Prevascar on 1cm incisional and excisional scars in subjects of African Continental Group ancestry, as compared to placebo, and to further investigate the safety and tolerance of intradermally injected Prevascar in wounds.

Conditions

Scarring

Outcome Measures

Primary Outcomes (1)

• To assess the effects of Prevascar on resultant scars

  To investigate the effects of Prevascar on wound/scar width To investigate the effects of Prevascar on wound/scar tissue histology To investigate the effects of Prevascar on scar appearance NB: This is an exploratory study and hence all objectives are exploratory

  13 months

Study Arms (4)

Group 2 - 2 doses of Prevascar and placebo

EXPERIMENTAL

Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng

Group 1 - 2 doses of Prevascar and placebo

EXPERIMENTAL

Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng

Group 3 - 2 doses of Prevascar and placebo

EXPERIMENTAL

Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng

Group 4 - 2 doses of Prevascar and placebo

EXPERIMENTAL

Drug: Prevascar 5ng; Drug: Prevascar 25ng; Drug: Prevascar 100ng; Drug: Prevascar 250ng

Interventions

Prevascar 5ng DRUG

100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Group 1 - 2 doses of Prevascar and placebo; Group 2 - 2 doses of Prevascar and placebo; Group 3 - 2 doses of Prevascar and placebo; Group 4 - 2 doses of Prevascar and placebo

Prevascar 25ng DRUG

• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Group 1 - 2 doses of Prevascar and placebo; Group 2 - 2 doses of Prevascar and placebo; Group 3 - 2 doses of Prevascar and placebo; Group 4 - 2 doses of Prevascar and placebo

Prevascar 100ng DRUG

• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Group 1 - 2 doses of Prevascar and placebo; Group 2 - 2 doses of Prevascar and placebo; Group 3 - 2 doses of Prevascar and placebo; Group 4 - 2 doses of Prevascar and placebo

Prevascar 250ng DRUG

• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.

Group 1 - 2 doses of Prevascar and placebo; Group 2 - 2 doses of Prevascar and placebo; Group 3 - 2 doses of Prevascar and placebo; Group 4 - 2 doses of Prevascar and placebo

Eligibility Criteria

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

You may qualify if:

• Afro-Caribbean male and female subjects between 18 and 85 years of age.

You may not qualify if:

• Subjects who on direct questioning or examination have history or evidence of keloid scarring.
• Subjects who have evidence of any past or present clinically significant medical condition that would impair wound healing or trial assessments
• Subjects with a history of clinically significant hypersensitivity to any of the drugs or surgical dressings to be used in this trial.
• Subjects who are taking, or have taken, any investigational drugs within 3 months prior to the screening visit.
• Female subjects who are, or who become pregnant up to and including Day 0 and/ or who are lactating.
• In the opinion of the Investigator, a subject who is not likely to complete the trial for whatever reason.

Sponsors & Collaborators

• Renovo: lead

Study Sites (1)

Renovo Clinical Trials Unit

Manchester, Greater Manchester, M13 9XX, United Kingdom

Location

MeSH Terms

Conditions

Cicatrix

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: April 30, 2010
• First Posted: May 4, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: February 10, 2011

Record last verified: 2011-02

Locations

GB (1)