An exploratory, single centre, randomized, placebo controlled, assessor blind clinical trial to assess the effects of intradermal administrations of Prevascar on scarring in human subjects of African Continental Ancestral origi
- Conditions
- Improvement of scarring in subjects of African Continental Group ancestryTherapeutic area: Body processes [G] - Physiological processes [G07]
- Registration Number
- EUCTR2009-017400-91-GB
- Lead Sponsor
- Renovo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 56
-Male and female subjects between 18 and 85 years of age.
NB Female subjects must be either of non child-bearing potential as defined in Section 4.4, or if of child-bearing potential must satisfy the contraceptive criteria as defined in section 4.4.
-Subjects who have a body mass index between 18 and 35 kg/m2 inclusive.
-Subjects who have given written informed consent, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6.
-Subjects with, in the opinion of the Investigator, clinically acceptable laboratory results for the laboratory tests specified in the Protocol (see section 6.4.2). All laboratory tests must be performed within twenty eight days of the first trial dose administration.
-Subjects who consider themselves of African Continental Group Ancestral Origin.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 56
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
- Subjects considered for the trial must not fulfil any of the following criteria:
- Subjects who on direct questioning or examination have history or evidence of keloid scarring.
- Subjects with tattoos, birthmarks, moles or previous scars within 3cm of the area to be incised in the trial.
- Subjects who have had surgery in the area to be incised within 1 year of the first dosing day.
- Subjects who on direct questioning and / or physical examination, have evidence of any past or present clinically significant medical condition that would impair wound healing including:
-Significant rheumatoid arthritis.
-Significant hepatic impairment (LFTs >3 times upper limit of normal).
-Inadequately or uncontrolled congestive heart failure.
-Significant cerebrovascular disease including a history of stroke, transient ischemic attacks or haemorrhage
-Uncontrolled hypertension SBP > 180 mmHg, DBP > 95mmHg
-Currently active malignancy or history of any malignancy in the 5 years prior to the screening visit.
-Immunosuppression or chemotherapy in the twelve months prior to the screening visit.
-A history of radiotherapy to the study scar area.
-Diabetes mellitus (unless controlled by diet and exercise alone).
-A bleeding disorder including haemophilia, purpura, or thrombocytopenia or current use of anti-thrombotic therapy (aspirin, ticlopidine and clopidogrel are permitted).
- Subjects with a skin disorder that is chronic or currently active.
- Subjects with a progressive neurological condition, including Parkinson’s disease, Alzheimer’s disease and uncontrolled epilepsy.
- Subjects who, in the opinion of the Investigator, have significant ongoing psychiatric disorders (including depression with psychosis, bipolar disease and schizophrenia), which may interfere with the trial assessments / visits.
- Subjects with a known history of chronic viral infection (Hepatitis, HIV) or ongoing active infection.
- Subjects with a known history of substance abuse or dependency (a history of recreational use of cannabis is acceptable assuming a negative urine test at screening; Subjects who have a history of alcohol abuse but have been dependency free for twelve months will be eligible).
- 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.
- Subjects undergoing investigations or changes in management for an existing medical condition.
- 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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.;Secondary Objective: To further investigate the safety and tolerance of intradermally injected Prevascar in wounds.;Primary end point(s): The primary trial endpoint is the improvement of Prevascar treated scars compare with placebo treated scars at 12 months post excision surgery (i.e. month 13 from day 0) as assessed by an independent expert clinical panel using a Global Scar Comparison Scale;Timepoint(s) of evaluation of this end point: 12 months post excision surgery (i.e. month 13 from Day 0)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): None.;Timepoint(s) of evaluation of this end point: Not Applicable.