ScarringPhase 1SSCARTNCT03514615
A Trial to Assess the Safety and Efficacy of Topical Salbutamol in Healthy Volunteers.
A Phase 1 study testing Incision and Active gel in people with Scarring, run by University Hospitals, Leicester at 1 site in United Kingdom.
Trial summary
This will be a single centre, double-blind, placebo (vehicle) controlled, randomised, dose escalation trial. Three concentrations of topical salbutamol gel will be compared, in a group-wise fashion, with a placebo administration at one incision site on each arm of the trial subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Scarring
- What is being tested?
- Incision and Active gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Jan 2018to 1 Jul 2019
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able, in the opinion of the investigator, and willing to give informed consent
- Aged 18 - 50 inclusive, with both arms
- Participants registered on The Over Volunteering Prevention System (TOPS) or equivalent in Leicester.
- Body mass index within the range 15.0-35.0 kg/m2. Inclusive (i.e. ≥ 15.0 and ≤ 35.0)
- In the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 11.2). All laboratory tests must be performed within 28 days of the subject's first trial dose administration.
- Women of child bearing potential (WOCBP) must be using a highly effective means of contraception and agree to do so from at least the screening visit until trial end or completion of the trial.
Who cannot join
- On direct questioning, have evidence of Left/Right Confusion.
- On direct questioning and/or physical examination a history or evidence of keloid scarring.
- On direct questioning have a family history of keloid scarring.
- Tattoos or previous scars within 3cm of the area to be incised during the trial.
- Surgery in the area to be incised and have surgical scars within 3cm of this area.
- History of a bleeding disorder or who are receiving anti-coagulant or anti-platelet therapy.
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- On direct questioning and physical examination, have evidence of any past or present clinically significant disease that may affect the endpoints of the trial. For example: Coagulation disorders, diabetes, immuno-mediated conditions or allergies (including allergic contact dermatitis).
- Subjects with a clinically significant skin disorder (dermatitis, eczema, psoriasis) that is chronic or currently active and which the Investigator considers will adversely affect the healing of the acute wounds or involves the areas to be examined in this trial.
- Any clinically significant medical condition or history that would impair wound healing including:
- Rheumatoid arthritis.
- Chronic renal impairment for their age.
- Hepatic impairment (LFTs >3 times upper limit of normal).
- Congestive heart failure.
- Pre-existing ischemic heart disease
- Pulmonary hypertension
- Hypertrophic obstructive cardiomyopathy
- Aortic stenosis
- Current active malignancy or history of malignancy in the last 5 years.
- Immunosuppression or chemotherapy within the last 12 months.
- A history of radiotherapy at the areas to be studied.
- Diabetes mellitus.
- Subjects with proven diagnosis of thyroid disease
- A history of hypersensitivity to any of the drugs or dressings used in this trial
- Currently taking other prescribed treatments:
- All corticosteroids, whether topically applied or systemic;
- Any salbutamol containing preparations
- Other beta-agonists, such as salmeterol
- Any beta-blockers, such as propranolol
- Other beta antagonists
- Adrenaline
- Undergoing investigations or changes in management for an existing medical condition.
- History of drug abuse, including cocaine, amphetamines, methamphetamines, opiates or benzodiazepines.
- In the opinion of the investigator, are unlikely to complete the trial for whatever reason.
- Any clinically significant neurological impairment or disease, including body dysmorphia.
- At entry into the trial, any active infection.
- Pregnant or lactating or planning to become pregnant during the duration of the trial.
- Not involved with any other clinical trial of medicinal product at the time of consent or 3 months prior.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo Controlled, Randomised Dose Escalation Trial to Investigate the Safety and Efficacy of Topical Salbutamol in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers.
This will be a single centre, double-blind, placebo (vehicle) controlled, randomised, dose escalation trial. Three concentrations of topical salbutamol gel will be compared, in a group-wise fashion, with a placebo administration at one incision site on each arm of the trial subjects. Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active substance, while the other will receive placebo.
- Conditions
- Scarring
- Being tested
- Incision, Active gel, Placebo gel
- Medical subject headings
- Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncisionProcedure or surgery
A skin incision will be made on the medial aspect of the upper arm.
Active gelDrug
The incision site on one arm will be dosed with the active gel.
Placebo gelDrug
The incision site on the other arm will be dosed with placebo gel.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Gel | Placebo comparator | Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo. Receives: Procedure: Incision; Drug: Placebo gel |
| Active Gel | Experimental | Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo. Receives: Procedure: Incision; Drug: Active gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak plasma concentration
The primary trial endpoint will be the peak plasma concentration of salbutamol at day 0.
Measured: 24 hours
Secondary outcomes (3)
Peak Plasma concentration 2
The peak plasma concentration of salbutamol at day 10.
Measured: 10 days
Efficacy of treatment using the Global Scar Comparison Scale
Improvement in scar appearance will be assessed using a global appearance scale, referred to as the "Global Scar Comparison Scale" (GSCS), which seeks to assess which one of a pair of scars is visually improved compared to the other. The scale is based on a 200mm Visual Analogue Scale, with "0"mm at the centre indicating no difference between the scars. The extremes of the scale -100mm to +100mm are reserved for one scar becoming imperceptible compared to the other. The assessment will be performed by both the patient and investigator independently at months 7, 9 and 12.
Measured: 12 months
Efficacy of treatment using the Patient Observer Scar Assessment Scale
Improvement in scar appearance will be assessed using the "Patient and Observer Scar Assessment Scale" (POSAS) which is a composite scale made up of sub-scales, that measure 12 items numerically (6 by the patient; scar pain, scar itch, colour differences, scar stiffness, scar thickness and scar irregularity) and six items scored by the investigator (vascularity, pigmentation, thickness, relief, pliability and surface area). The patient sub-scales are scored 1-10 where 1="no, not at all" and 10 = "yes, very much". The clinical sub-scores are also scored 1-10 with 1=normal skin and 10=worst scar imaginable. POSAS is calculated as a total score of all sub-scores. The assessment will be performed by both the patient and investigator independently at months 7, 9 and 12.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2018
- Study start10 Jan 2018
- Primary completion20 Jul 2018
- Study completion1 Jul 2019
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals, Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leicester, Medical Research Council
- Responsible party
- Sponsor
- Investigators
- Graham Johnston, Principal investigator, University of Leicester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03514615
- Sponsor's protocol ID
- 97807
- Acronym
- SSCART
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2018
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Randomised Dose Escalation Trial to Investigate the Safety and Efficacy of Topical Salbutamol in the Improvement of Scar Appearance When Applied to Approximated Wound Margins in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT03514615
- Acronym / sponsor ID
- SSCART / 97807
- Conditions
- Scarring
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospitals, LeicesterUniversity, hospital or other
- Collaborators
- University of Leicester, Medical Research Council
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 20 Jul 2018 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 2 May 2018 (actual)
- 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.
This will be a single centre, double-blind, placebo (vehicle) controlled, randomised, dose escalation trial. Three concentrations of topical salbutamol gel will be compared, in a group-wise fashion, with a placebo administration at one incision site on each arm of the trial subjects. Each participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active substance, while the other will receive placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Gel | Placebo comparator | Procedure: Incision, Drug: Placebo gelEach participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo. |
| Active Gel | Experimental | Procedure: Incision, Drug: Active gelEach participant will be allocated to only one dosing group. The treatments will be paired anatomically so that for each pair of sites, one closed incision site will receive the active gel and the other placebo. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able, in the opinion of the investigator, and willing to give informed consent
- Aged 18 - 50 inclusive, with both arms
- Participants registered on The Over Volunteering Prevention System (TOPS) or equivalent in Leicester.
- Body mass index within the range 15.0-35.0 kg/m2. Inclusive (i.e. ≥ 15.0 and ≤ 35.0)
- In the opinion of the investigator, clinically acceptable results for the laboratory tests specified in the trial protocol (see Protocol Section 11.2). All laboratory tests must be performed within 28 days of the subject's first trial dose administration.
Key exclusion criteria (37 listed)
- On direct questioning, have evidence of Left/Right Confusion.
- On direct questioning and/or physical examination a history or evidence of keloid scarring.
- On direct questioning have a family history of keloid scarring.
- Tattoos or previous scars within 3cm of the area to be incised during the trial.
- Surgery in the area to be incised and have surgical scars within 3cm of this area.
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 |
|---|---|---|
| IncisionA skin incision will be made on the medial aspect of the upper arm. | Procedure or surgery | Active Gel, Placebo Gel |
| Active gelThe incision site on one arm will be dosed with the active gel. | Drug | Active Gel |
| Placebo gelThe incision site on the other arm will be dosed with placebo gel. | Drug | Placebo Gel |
Primary outcome
Peak plasma concentration
Time frame: 24 hours
The primary trial endpoint will be the peak plasma concentration of salbutamol at day 0.
3 secondary outcomes
Peak Plasma concentration 2
Time frame: 10 days
Efficacy of treatment using the Global Scar Comparison Scale
Time frame: 12 months
Efficacy of treatment using the Patient Observer Scar Assessment Scale
Time frame: 12 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 26 Mar 2020.
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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.
Graham Johnston principal investigator
University of Leicester
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 Incision and Active gel in people with Scarring, run by University Hospitals, Leicester at 1 site in United Kingdom.
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 6 inclusion and 37 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 26 Mar 2020. 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 United Kingdom. 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?
Peak plasma concentration (time frame: 24 hours). 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 26 Mar 2020.