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

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ClinicalTrials.gov Identifier: NCT03036306
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
ScarX Corp

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Scarring Drug: SCX-001 Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2017
Actual Primary Completion Date : October 2, 2017
Actual Study Completion Date : October 2, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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
Drug: SCX-001
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
Drug: SCX-001
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
Other: Placebo
Cream formulation without Nefopam




Primary Outcome Measures :
  1. Occurrence of Adverse Events and Tolerability Assessments [ Time Frame: 4 months ]
    Adverse events, Tolerability assessments


Secondary Outcome Measures :
  1. 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

  2. Scar Quality [ Time Frame: 4 months ]
    Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study

  3. 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. Area under the plasma concentration-time curve (AUC) [ Time Frame: 4 weeks ]
    Serial serum samples to determine AUC (0-6h, 0-8h)

  5. Time to reach maximum observed plasma concentration (Tmax) [ Time Frame: 4 weeks ]
    Serial serum samples to determine Tmax

  6. Maximum observed plasma concentration (Cmax) [ Time Frame: 4 weeks ]
    Serial serum samples to determine Cmax

  7. 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

  8. Histological analysis [ Time Frame: Done on the day of the last dose of treatment (20 days following wounding) ]
    Immunohistochemistry on scar biopsy samples

  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female volunteers aged ≥18 - ≤65 years who have voluntarily signed and dated an Informed Consent Form (ICF).
  2. Subjects with, in the opinion of the Investigator, clinically acceptable results at screening for the laboratory tests specified in the trial protocol.
  3. 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.
  4. 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.
  5. 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:

  1. 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.
  2. Subjects with a history or family history of keloid formation.
  3. 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.
  4. 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)
  5. Subjects with a body mass index <15 or >35 kg/m2.
  6. A history of radiotherapy to the study scar area.
  7. Subjects who have used nicotine-containing products (including vaping) within one month prior to the screening visit.
  8. Subjects who are positive for HIV, hepatitis B or C.
  9. Subjects who have known sensitivities to SCX-001 Cream, structurally related compounds or any of the constituents of SCX-001 Cream.
  10. Subjects who have known sensitivities to EMLA cream, chlorhexidine or adhesive dressings
  11. Subjects with a history of any malignancy in the five years prior to the screening visit.
  12. Subjects with a life expectancy of <9 months, terminal conditions or factors making follow-up difficult (e.g. no fixed address, telephone etc.).
  13. Subjects with planned major surgical intervention during the course of the study.
  14. 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.
  15. Subjects who have received NSAIDS or ASA in the past week.
  16. Subjects with a creatinine clearance of 80 ml/min or less.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036306


Locations
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Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
ScarX Corp

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Responsible Party: ScarX Corp
ClinicalTrials.gov Identifier: NCT03036306     History of Changes
Other Study ID Numbers: SCX-001-1
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: October 4, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by ScarX Corp:
scar
nefopam
cicatrix

Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes
Nefopam
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs