PainPhase 1NCT04114656
Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Volunteers
A Phase 1 study testing GSK3858279 in people with Pain, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
This study will evaluate the mechanistic basis for the analgesic effects of GSK3858279 in humans by using a battery of experimental pain assessments in healthy participants. This will be placebo-controlled, three-period two-treatment crossover study. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- GSK3858279
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Oct 2019to 16 Sep 2021
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring.
- Participants with body weight within 50-100 kg and body mass index (BMI) within the range 18 to 30 kg per meter square (kg/m^2) (inclusive).
- Must be male participants: Participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
- Refrain from donating sperm plus, either
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or
Show all 9Show fewer
- Must agree to use contraception/barrier as detailed below:
- Agree to use a male condom. (ii) And should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Who cannot join
- Participants with history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Personal or family history of cardiomyopathy.
- Abnormal blood pressure as determined by the investigator.
- Symptomatic herpes zoster within 3 months prior to screening.
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, and TB testing: a positive (not indeterminate) QuantiFERON-TB Gold test.
- Significant allergies to humanized monoclonal antibodies.
Show all 47Show fewer
- Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A [IgA] dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis).
- Lymphoma, leukemia, or any malignancy. Those who are at risk of deoxyribonucleic acid (DNA) repair diseases or any family history of DNA repair disease.
- Alanine transaminase (ALT) greater than (>)1.5 times upper limit of normal (ULN).
- Bilirubin >1.5 times ULN (isolated bilirubin >1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than [<]35%).
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Corrected QT interval (QTc) >450 msec.
- History of Stevens-Johnson syndrome.
- Known immunodeficiency.
- Participants with an acute, recurrent or chronic infection (for example, osteomyelitis), who have been receiving treatment within three months prior to dosing or individuals with an active infection.
- Previous or current history of excessive bleeding or coagulation disorders.
- Previous history of hypertrophic or keloid scarring.
- Any current, clinically significant, known medical condition in particular any existing conditions that would affect sensitivity to cold (such as atherosclerosis, Raynaud's disease, urticaria, and hypothyroidism) or pain (such as disease that causes pain, hypesthesia, hyperalgesia, allodynia, paraesthesia, neuropathy).
- Participants indicating pain tests intolerable at screening. Participants achieving tolerance at >80% of maximum input intensity for cold pressor and electrical pain tests are to be excluded. If pressure pain test tolerance is >80% of maximum input intensity they may be enrolled as per Principal Investigator (PI) judgement.
- History or presence of post-inflammatory hyperpigmentation. Applicable for the participants in the UVB-Modified Intent-To-Treat (MITT) population only.
- Participants with Fitzpatrick skin type IV, V or VI. Applicable for the participants in the UVB-MITT population only.
- Any of the following on the proposed test area on the back: widespread acne, freckles, tattoos, birthmarks or scarring (investigator discretion may be used to determine if small areas may be avoided in the testing area on the back). Applicable for the participants in the UVB-MITT population only.
- A minimal erythema dose (MED) higher than 355 millijoule per square centimeter (mJ/cm^2) at screening. Applicable for the participants in the UVB-MITT population only.
- Past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to screening until after follow-up visit.
- Live vaccine(s) within 1 month prior to screening or plans to receive such vaccines during the study.
- Treatment with biologic agents (such as monoclonal antibodies including marketed drugs) or immunosuppressants within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Treatment with anti-platelet or anti-coagulant agents within 7 days of dosing.
- Major surgery (as per investigator's judgement) within 3 months prior to dosing.
- Participant has made a blood or plasma donation or has had a comparable blood loss (>450 milliliters [mL]) within the last 3 months prior to the Screening Visit. Blood donation during the study is not permitted.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrollment or past participation in any other clinical study involving an investigational study intervention within the last 3 months, 5-half-lives or twice the duration of the biological product before screening in this current study.
- Presence of Hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
- Presence of Hepatitis B core antibody (HbcAb) at screening or within 3 months prior to first dose of study intervention.
- Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive Hepatitis C ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
- Abnormal clinically significant echocardiogram at screening, as assessed by the investigator.
- Cardiac troponin T or N-terminal pro-brain natriuretic peptide (NT-proBNP) levels out of normal range at screening.
- Positive pre-study drug/alcohol screen.
- Positive human immunodeficiency virus (HIV) antibody test.
- Regular use of known drugs of abuse.
- Estimated glomerular filtration rate (eGFR) of <90 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) or serum creatinine >1.5 times ULN or urine albumin:creatinine ratio of >300 mg per gram (g) at screening.
- Positive Severe acute respiratory syndrome- Coronavirus-2 (SARS-CoV-2) Polymerase chain reaction (PCR) or rapid antigen test at screening. Participants may be re-screened once they present a negative SARS-CoV-2 PCR or rapid antigen test.
- Participants with known Coronavirus Disease-2019 (COVID-19 positive contacts in the past 14 days.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of >21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- Smoker, smoking history or use of tobacco- or nicotine-containing products (for example, nicotine patches or vaporizing devices) within 6 months prior to screening.
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Three-period Two-treatment Incomplete-block Crossover Study to Investigate the Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Participants
This study will evaluate the mechanistic basis for the analgesic effects of GSK3858279 in humans by using a battery of experimental pain assessments in healthy participants. This will be placebo-controlled, three-period two-treatment crossover study. In each period, participants will receive either GSK3858279 or placebo in a 1:1 ratio. Only healthy male participants will be enrolled into the study. The duration of the study will be approximately 6 months.
- Conditions
- Pain
- Being tested
- Placebo, GSK3858279
- Keywords
- GSK3858279, Crossover study, Pain assessment, Placebo-controlled, Intravenous
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be available as intravenous (IV) infusion of normal saline (0.9 percent [%] sodium chloride solution).
GSK3858279Drug
GSK3858279 will be available as IV infusion and the dose level to be administered is 3 milligrams (mg) per kilogram (kg).
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Placebo | Placebo comparator | All participants will receive a single dose of placebo in either one or two of the three study periods, as per the randomization schedule. Receives: Drug: Placebo |
| Participants receiving GSK3858279 | Experimental | All participants will receive a single dose of GSK3858279 in either one or two of the three study periods, as per the randomization schedule. Receives: Drug: GSK3858279 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Posterior Median Ratio to Baseline of Area Under the Curve (AUC 1-8 Days) in Ultraviolet B (UVB) Heat Pain Detection
Thermal pain tests performed first on normal skin contralateral to site of UVB irradiation then on UVB irradiated skin.A 30*30 millimeter(mm)thermode was placed on participant's back. Initial temperature of thermode was 32 degree Celsius(C)and increased by 0.5 degree C/second until participant indicated painful stimulus(pain detection threshold indicated by pushing a button on hand-held feedback control or when temperature of 50 degree C reached).AUC ratio to Baseline derived from log change from Baseline in temperature versus(vs)time of study period calculated via trapezoidal method \&normalized \& back transformed(exponential)to get ratio to Baseline. Baseline was mean value of 2 assessments taken before each dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior(non-informative)with information collected from study(likelihood).Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'.
Measured: Baseline (Day 1) and up to Day 8
Posterior Median Ratio to Baseline of AUC (1-15 Days) in Cold Pressor Time to Intolerable Pain Threshold
Participants put non-dominant hand in water bath at 35+/-0.5 degree C.Blood pressure cuff on upper arm inflated to 20mm of Mercury below resting diastolic pressure. Participants then removed hand \& directly placed in similar-size bath(1.0+/-0.5 degree C).Participants indicated increase in pain intensity by moving electronic Visual Analogue scale(eVAS) slider when pain detection threshold was reached(first change in sensation from cold non-painful to painful).When pain tolerance was reached, participants removed their hand\& blood pressure cuff was deflated.AUC ratio to Baseline derived from log change from Baseline in time to intolerable pain vs time of study period calculated via trapezoidal method \&normalized and back transformed(exponential) to get ratio to Baseline.Baseline was mean value of 2 assessments taken before each dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior(non-informative)with information collected from study(likelihood).
Measured: Baseline (Day 1) and up to Day 15
Posterior Median Ratio to Baseline of AUC (1-15 Days) in Electrical Pain Tolerance Threshold (Single Stimulus)
Two electrodes were placed on clean (scrubbed) skin overlying left tibial bone 100mm distal from caudal end of patella to detect cutaneous electrical pain. Each stimulus(10-Hertz [Hz] tetanic pulse with duration of 0.2 milliseconds) was controlled by a computer-controlled constant current stimulator.Pain intensity after each stimulation was measured using eVAS,until pain tolerance level was reached,or maximum of 50 milliamper(mA) was reached. AUC ratio to Baseline derived from log change from Baseline in mA versus time of study period calculated via trapezoidal method and normalized and back transformed(exponential)to get ratio to Baseline. Baseline was mean value of 2 assessments taken before dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior (non-informative) with information collected from study(likelihood).Data reported as 'Median' refers to'Posterior Median'and data reported as'95% Confidence Interval' refers to '95% Credible Interval'.
Measured: Baseline (Day 1) and up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start15 Oct 2019
- Primary completion16 Sep 2021
- Study completion16 Sep 2021
Why it stopped: This study was terminated due to meeting protocol defined futility.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114656
- Sponsor's protocol ID
- 209973
- Other IDs
- 2019-002609-23, 2019
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2019
- Last updated
- 18 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
Publications
Boyle Y, Hijma HJ, Rees J, Nijjar J, Panoilia E, Alvarez Y, Siederer S, Greening E, Emery E, Abbott Banner K, Groeneveld GJ. Randomized, placebo-controlled study on the effects of intravenous GSK3858279 (anti-CCL17) on a battery of evoked pain tests in healthy participants. Clin Transl Sci. 2024 Sep;17(9):e13873. doi: 10.1111/cts.13873.
PubMed 39250326
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Three-period Two-treatment Incomplete-block Crossover Study to Investigate the Effects of Intravenous GSK3858279 on a Battery of Evoked Pain Tests in Healthy Participants
- ClinicalTrials.gov ID
- NCT04114656
- Acronym / sponsor ID
- 209973
- Conditions
- Pain
- Keywords
- GSK3858279, Crossover study, Pain assessment, Placebo-controlled, Intravenous
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to meeting protocol defined futility.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 16 Sep 2021 (actual)
- First posted
- 3 Oct 2019 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the mechanistic basis for the analgesic effects of GSK3858279 in humans by using a battery of experimental pain assessments in healthy participants. This will be placebo-controlled, three-period two-treatment crossover study. In each period, participants will receive either GSK3858279 or placebo in a 1:1 ratio. Only healthy male participants will be enrolled into the study. The duration of the study will be approximately 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Placebo | Placebo comparator | Drug: PlaceboAll participants will receive a single dose of placebo in either one or two of the three study periods, as per the randomization schedule. |
| Participants receiving GSK3858279 | Experimental | Drug: GSK3858279All participants will receive a single dose of GSK3858279 in either one or two of the three study periods, as per the randomization schedule. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Participants must be 18 to 50 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring.
- Participants with body weight within 50-100 kg and body mass index (BMI) within the range 18 to 30 kg per meter square (kg/m^2) (inclusive).
- Must be male participants: Participants must agree to the following during the intervention period and for at least 90 days after the last dose of study intervention:
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Key exclusion criteria (47 listed)
- Participants with history or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Personal or family history of cardiomyopathy.
- Abnormal blood pressure as determined by the investigator.
- Symptomatic herpes zoster within 3 months prior to screening.
- Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, and TB testing: a positive (not indeterminate) QuantiFERON-TB Gold test.
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 |
|---|---|---|
| PlaceboPlacebo will be available as intravenous (IV) infusion of normal saline (0.9 percent [%] sodium chloride solution). | Drug | Participants receiving Placebo |
| GSK3858279GSK3858279 will be available as IV infusion and the dose level to be administered is 3 milligrams (mg) per kilogram (kg). | Drug | Participants receiving GSK3858279 |
Primary outcome
Posterior Median Ratio to Baseline of Area Under the Curve (AUC 1-8 Days) in Ultraviolet B (UVB) Heat Pain Detection
Time frame: Baseline (Day 1) and up to Day 8
Thermal pain tests performed first on normal skin contralateral to site of UVB irradiation then on UVB irradiated skin.A 30*30 millimeter(mm)thermode was placed on participant's back. Initial temperature of thermode was 32 degree Celsius(C)and increased by 0.5 degree C/second until participant indicated painful stimulus(pain detection threshold indicated by pushing a button on hand-held feedback control or when temperature of 50 degree C reached).AUC ratio to Baseline derived from log change from Baseline in temperature versus(vs)time of study period calculated via trapezoidal method \&normalized \& back transformed(exponential)to get ratio to Baseline. Baseline was mean value of 2 assessments taken before each dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior(non-informative)with information collected from study(likelihood).Data reported as 'Median' refers to 'Posterior Median' and '95% Confidence Interval' refers to '95% Credible Interval'.
Posterior Median Ratio to Baseline of AUC (1-15 Days) in Cold Pressor Time to Intolerable Pain Threshold
Time frame: Baseline (Day 1) and up to Day 15
Participants put non-dominant hand in water bath at 35+/-0.5 degree C.Blood pressure cuff on upper arm inflated to 20mm of Mercury below resting diastolic pressure. Participants then removed hand \& directly placed in similar-size bath(1.0+/-0.5 degree C).Participants indicated increase in pain intensity by moving electronic Visual Analogue scale(eVAS) slider when pain detection threshold was reached(first change in sensation from cold non-painful to painful).When pain tolerance was reached, participants removed their hand\& blood pressure cuff was deflated.AUC ratio to Baseline derived from log change from Baseline in time to intolerable pain vs time of study period calculated via trapezoidal method \&normalized and back transformed(exponential) to get ratio to Baseline.Baseline was mean value of 2 assessments taken before each dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior(non-informative)with information collected from study(likelihood).
Posterior Median Ratio to Baseline of AUC (1-15 Days) in Electrical Pain Tolerance Threshold (Single Stimulus)
Time frame: Baseline (Day 1) and up to Day 15
Two electrodes were placed on clean (scrubbed) skin overlying left tibial bone 100mm distal from caudal end of patella to detect cutaneous electrical pain. Each stimulus(10-Hertz [Hz] tetanic pulse with duration of 0.2 milliseconds) was controlled by a computer-controlled constant current stimulator.Pain intensity after each stimulation was measured using eVAS,until pain tolerance level was reached,or maximum of 50 milliamper(mA) was reached. AUC ratio to Baseline derived from log change from Baseline in mA versus time of study period calculated via trapezoidal method and normalized and back transformed(exponential)to get ratio to Baseline. Baseline was mean value of 2 assessments taken before dosing(Day 1).Posterior Median Ratio to Baseline derived from Bayesian analysis updating prior (non-informative) with information collected from study(likelihood).Data reported as 'Median' refers to'Posterior Median'and data reported as'95% Confidence Interval' refers to '95% Credible Interval'.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39250326Boyle Y, Hijma HJ, Rees J, Nijjar J, Panoilia E, Alvarez Y, Siederer S, Greening E, Emery E, Abbott Banner K, Groeneveld GJ. Randomized, placebo-controlled study on the effects of intravenous GSK3858279 (anti-CCL17) on a battery of evoked pain tests in healthy participants. Clin Transl Sci. 2024 Sep;17(9):e13873. doi: 10.1111/cts.13873.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 GSK3858279 in people with Pain, run by GlaxoSmithKline at 1 site in Netherlands.
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 9 inclusion and 47 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: stopped early, as of the sponsor's last update on 18 Mar 2024. 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 Netherlands. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Posterior Median Ratio to Baseline of Area Under the Curve (AUC 1-8 Days) in Ultraviolet B (UVB) Heat Pain Detection (time frame: Baseline (Day 1) and up to Day 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04114656, which also lists 1 linked publication.
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 18 Mar 2024.