Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Scarring

Intervention / Treatment
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* Drug: SCX-001
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1.0 % SCX-001 cream<br>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 | Drug: SCX-001<br>* Nefopam cream formulation<br>|
| Experimental: 3.0% SCX-001 cream<br>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 | Drug: SCX-001<br>* Nefopam cream formulation<br>|
| Placebo Comparator: Placebo cream<br>Subjects randomized to this arm will have both lateral hip wounds treated with Placebo cream. Intra-subject hip wound treatment is randomly allocated | Other: Placebo<br>* Cream formulation without Nefopam<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of Adverse Events and Tolerability Assessments | Adverse events, Tolerability assessments | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scar Size | 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 | Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study | 4 months | 
| Time to Wound Closure | 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) | Serial serum samples to determine AUC (0-6h, 0-8h) | 4 weeks | 
| Time to reach maximum observed plasma concentration (Tmax) | Serial serum samples to determine Tmax | 4 weeks | 
| Maximum observed plasma concentration (Cmax) | Serial serum samples to determine Cmax | 4 weeks | 
| Gene expression analysis | RT-qPCR on scar biopsy samples | Done on the day of the last dose of treatment (20 days following wounding) | 
| Histological analysis | Immunohistochemistry on scar biopsy samples | Done on the day of the last dose of treatment (20 days following wounding) | 
| Collagen orientation analysis | Collagen orientation index on scar biopsy samples | Done on the day of the last dose of treatment (20 days following wounding) | 
| Overall Satisfaction | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scar, nefopam, cicatrix