ScarringPhase 1NCT03036306
Dose Ranging Study to Evaluate the Safety and Tolerability of SCX-001 Cream in Healthy Volunteers With Induced Dermal Incisions
A Phase 1 study testing SCX-001 in people with Scarring, run by ScarX Corp at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Scarring
- What is being tested?
- SCX-001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to 2 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Scarring
- Being tested
- SCX-001, Placebo
- Keywords
- scar, nefopam, cicatrix
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCX-001Drug
Nefopam cream formulation
PlaceboOther
Cream formulation without Nefopam
| Study group | Role | What they receive |
|---|---|---|
| 1.0 % SCX-001 cream | Experimental | 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 Receives: Drug: SCX-001 |
| 3.0% SCX-001 cream | Experimental | 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 Receives: Drug: SCX-001 |
| Placebo cream | Placebo comparator | Subjects randomized to this arm will have both lateral hip wounds treated with Placebo cream. Intra-subject hip wound treatment is randomly allocated Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Adverse Events and Tolerability Assessments
Adverse events, Tolerability assessments
Measured: 4 months
Secondary outcomes (10)
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
Measured: 4 months
Scar Quality
Repeat measurement of erythema and pigmentation of scars by mexameter following wound closure to the end of study
Measured: 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
Measured: 4 months
Area under the plasma concentration-time curve (AUC)
Serial serum samples to determine AUC (0-6h, 0-8h)
Measured: 4 weeks
Time to reach maximum observed plasma concentration (Tmax)
Serial serum samples to determine Tmax
Measured: 4 weeks
Maximum observed plasma concentration (Cmax)
Serial serum samples to determine Cmax
Measured: 4 weeks
Gene expression analysis
RT-qPCR on scar biopsy samples
Measured: Done on the day of the last dose of treatment (20 days following wounding)
Histological analysis
Immunohistochemistry on scar biopsy samples
Measured: Done on the day of the last dose of treatment (20 days following wounding)
Collagen orientation analysis
Collagen orientation index on scar biopsy samples
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion2 Oct 2017
- Study completion2 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScarringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ScarX Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036306
- Sponsor's protocol ID
- SCX-001-1
- Status last verified
- Oct 2017
- First submitted
- 16 Jan 2017
- Last updated
- 4 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03036306
- Acronym / sponsor ID
- SCX-001-1
- Conditions
- Scarring
- Keywords
- scar, nefopam, cicatrix
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ScarX CorpIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- 2 Oct 2017 (actual)
- Study completion
- 2 Oct 2017 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1.0 % SCX-001 cream | Experimental | Drug: SCX-001Subjects 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 |
| 3.0% SCX-001 cream | Experimental | Drug: SCX-001Subjects 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 |
| Placebo cream | Placebo comparator | Other: PlaceboSubjects randomized to this arm will have both lateral hip wounds treated with Placebo cream. Intra-subject hip wound treatment is randomly allocated |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCX-001Nefopam cream formulation | Drug | 1.0 % SCX-001 cream, 3.0% SCX-001 cream |
| PlaceboCream formulation without Nefopam | Other | Placebo cream |
Primary outcome
Occurrence of Adverse Events and Tolerability Assessments
Time frame: 4 months
Adverse events, Tolerability assessments
10 secondary outcomes
Scar Size
Time frame: 4 months
Scar Quality
Time frame: 4 months
Time to Wound Closure
Time frame: 4 months
Area under the plasma concentration-time curve (AUC)
Time frame: 4 weeks
Time to reach maximum observed plasma concentration (Tmax)
Time frame: 4 weeks
Maximum observed plasma concentration (Cmax)
Time frame: 4 weeks
Gene expression analysis
Time frame: 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)
Collagen orientation analysis
Time frame: Done on the day of the last dose of treatment (20 days following wounding)
Overall Satisfaction
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCX-001 in people with Scarring, run by ScarX Corp at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Adverse Events and Tolerability Assessments (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2017.