- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036306
Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
October 3, 2017 updated by: ScarX Corp
A Randomized, Placebo Controlled, Double-blind, Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
The purpose of this study is to assess the safety and local tolerability of two different concentrations of of SCX-001 cream, as compared to placebo, when topically applied twice a day for 21 days to artificially induced dermal wounds in healthy volunteers.
In addition, the absorption and elimination of profiles of this topically applied product will be determined through pharmacokinetic sampling.
Assessments for effect of SCX-001 vs. placebo will be done but are considered exploratory.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
-
Edmonton, Alberta, Canada, T6G 2B7
- University of Alberta Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female volunteers aged ≥18 - ≤65 years who have voluntarily signed and dated an Informed Consent Form (ICF).
- Subjects with, in the opinion of the Investigator, clinically acceptable results at screening for the laboratory tests specified in the trial protocol.
- Women of child bearing potential must provide a negative pregnancy serum/urine test at time of screening and have to be compliant with an effective form of birth control throughout the entire study.* Non-child bearing potential means subjects have had a history of tubal ligation or a hysterectomy or are post-menopausal with no menses for at least 1 year prior to enrolment in the study.
- Subjects, who are, in the opinion of the Investigator, able to understand the study, co- operate with the study procedures and are willing to return to the clinic for all of the required follow-up visits.
- Subjects must be able to cooperate with requirements of the study (e.g. able to speak, read and write English, expect to be available for adverse event monitoring for the duration of the study).
Exclusion Criteria:
- Subjects who have scarring from previous interventions or evidence of thermal, electrical or radiation burn scars, tattoos, birthmarks or moles within 5 cm of the treatment site.
- Subjects with a history or family history of keloid formation.
- Subjects with a concurrent illness or condition that may have interfered with wound healing like neoplastic, immune-mediated, or primary infectious disease (e.g. carcinoma, vasculitis, connective tissue disease, immune system disorders, rheumatoid arthritis, chronic renal impairment, significant hepatic impairment, inadequately or uncontrolled congestive heart failure or diabetes mellitus) or any clinically significant medical condition or history of any condition which may impair wound healing.
- Subjects with a skin disorder that is chronic or currently active and which the Investigator considers will adversely affect the healing of acute wounds or will involve the areas to be examined in this trial (including psoriasis, dermatitis, eczema)
- Subjects with a body mass index <15 or >35 kg/m2.
- A history of radiotherapy to the study scar area.
- Subjects who have used nicotine-containing products (including vaping) within one month prior to the screening visit.
- Subjects who are positive for HIV, hepatitis B or C.
- Subjects who have known sensitivities to SCX-001 Cream, structurally related compounds or any of the constituents of SCX-001 Cream.
- Subjects who have known sensitivities to EMLA cream, chlorhexidine or adhesive dressings
- Subjects with a history of any malignancy in the five years prior to the screening visit.
- Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc.).
- Subjects with planned major surgical intervention during the course of the study.
- Subjects who have received corticosteroids, immunosuppressive agents, anticoagulants, radiation therapy or chemotherapy at a dose that might have interfered with wound healing within the last 90 days prior to study enrolment.
- Subjects who have received NSAIDS or ASA in the past week.
- Subjects with a creatinine clearance of 80 ml/min or less.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1.0 % SCX-001 cream
Subjects randomized to this arm will have one lateral hip wound treated with 1.0% SCX-001 cream and one wound treated with placebo.
Intra-subject hip wound treatment is randomly allocated
|
Nefopam cream formulation
|
Experimental: 3.0% SCX-001 cream
Subjects randomized to this arm will have one lateral hip wound treated with 3.0% SCX-001 cream and one wound treated with placebo.
Intra-subject hip wound treatment is randomly allocated
|
Nefopam cream formulation
|
Placebo Comparator: Placebo cream
Subjects randomized to this arm will have both lateral hip wounds treated with Placebo cream.
Intra-subject hip wound treatment is randomly allocated
|
Cream formulation without Nefopam
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Occurrence of Adverse Events and Tolerability Assessments
Time Frame: 4 months
|
Adverse events, Tolerability assessments
|
4 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scar Size
Time Frame: 4 months
|
Repeat measurement of scar size by ultrasound following wound closure to the end of study and digital camera following wounding to the end of the study
|
4 months
|
Scar Quality
Time Frame: 4 months
|
Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study
|
4 months
|
Time to Wound Closure
Time Frame: 4 months
|
Repeat examination of wounds for closure defined as 100% epithelialization of the wound with no exudate observed assessed form time of wounding to wound closure on both hips
|
4 months
|
Area under the plasma concentration-time curve (AUC)
Time Frame: 4 weeks
|
Serial serum samples to determine AUC (0-6h, 0-8h)
|
4 weeks
|
Time to reach maximum observed plasma concentration (Tmax)
Time Frame: 4 weeks
|
Serial serum samples to determine Tmax
|
4 weeks
|
Maximum observed plasma concentration (Cmax)
Time Frame: 4 weeks
|
Serial serum samples to determine Cmax
|
4 weeks
|
Gene expression analysis
Time Frame: Done on the day of the last dose of treatment (20 days following wounding)
|
RT-qPCR on scar biopsy samples
|
Done on the day of the last dose of treatment (20 days following wounding)
|
Histological analysis
Time Frame: Done on the day of the last dose of treatment (20 days following wounding)
|
Immunohistochemistry on scar biopsy samples
|
Done on the day of the last dose of treatment (20 days following wounding)
|
Collagen orientation analysis
Time Frame: Done on the day of the last dose of treatment (20 days following wounding)
|
Collagen orientation index on scar biopsy samples
|
Done on the day of the last dose of treatment (20 days following wounding)
|
Overall Satisfaction
Time Frame: 4 months
|
Repeat measurement of both subject and investigator satisfaction with scar appearance by Subject and Observer Scar Assessment Scale (POSAS) following wound closure to the end of study
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2017
Primary Completion (Actual)
October 2, 2017
Study Completion (Actual)
October 2, 2017
Study Registration Dates
First Submitted
January 16, 2017
First Submitted That Met QC Criteria
January 26, 2017
First Posted (Estimate)
January 30, 2017
Study Record Updates
Last Update Posted (Actual)
October 4, 2017
Last Update Submitted That Met QC Criteria
October 3, 2017
Last Verified
October 1, 2017
More Information
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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