Prevascar in African Continental Group Scarring

Renovo

Status and phase: Unknown; Phase 1

Conditions: Scarring

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01115868

RN1003-0110

Details and patient eligibility

About

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.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 4 patient groups

Group 2 - 2 doses of Prevascar and placebo

Experimental group

Treatment:

Drug: Prevascar 100ng

Drug: Prevascar 5ng

Drug: Prevascar 250ng

Drug: Prevascar 25ng

Group 1 - 2 doses of Prevascar and placebo

Experimental group

Treatment:

Drug: Prevascar 100ng

Drug: Prevascar 5ng

Drug: Prevascar 250ng

Drug: Prevascar 25ng

Group 3 - 2 doses of Prevascar and placebo

Experimental group

Treatment:

Drug: Prevascar 100ng

Drug: Prevascar 5ng

Drug: Prevascar 250ng

Drug: Prevascar 25ng

Group 4 - 2 doses of Prevascar and placebo

Experimental group

Treatment:

Drug: Prevascar 100ng

Drug: Prevascar 5ng

Drug: Prevascar 250ng

Drug: Prevascar 25ng