RosaceaNCT03878784
PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea
A study testing Imigran and Isotonic Saline in people with Rosacea, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with rosacea Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Rosacea
- What is being tested?
- Imigran and Isotonic Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Nov 2018to 19 Dec 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosed with rosacea
- weight between 50 - 100 kilograms
- women in fertile age must not be pregnant and must use adequate contraception
Who cannot join
- migraine more than 5 days per month in average over the past year
- any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
- headache < 48 hours before experimental day
- migraine < 72 hours before each experimental day
- daily / frequent use of any medication apart from contraceptive medication
- use of any drug less than 5 times the half-life of the drug at the time of the experiment
Show all 11Show fewer
- women who are pregnant or breast-feeding at the time of the experiment
- anamnestic or clinical signs of hypertension (systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg) or hypotension (systolic blood pressure < 90 mmHg and/or diastolic blood pressure < 50 mmHg)
- anamnestic or clinical signs of mental illness, or abuse of alcohol / drugs
- patients with glaucoma or prostate hyperplasia
- anamnestic or clinical symptoms of any sort that the investigating doctor deemed unfit for participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea
The investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with rosacea
Read the detailed description
Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in rosacea pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in migraine patients. PACAP38 also induces flushing which may imitate rosacea-like flushing. We are investigating whether the flushing after PACAP38 resembles rosacea-like flushing, and whether treatment with sumatriptan has an effect on the headache and flushing effects of PACAP38.
The purpose of this study is to investigate PACAP38-induced headache and flushing in patients with rosacea who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to investigate this.
- Conditions
- Rosacea
- Being tested
- Imigran, Isotonic Saline
- Medical subject headings
- Rosacea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImigranDrug
Also called Sumatriptan
All patients will undergo this intervention on one of two study days
Isotonic SalineOther
All patients will undergo this intervention on one of two study days
| Study group | Role | What they receive |
|---|---|---|
| PACAP38 + Imigran | Active comparator | Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins
AND
Imigrane infusion (0.4 mg/min) for 10 mins Receives: Drug: Imigran |
| PACAP38 + Isotonic Saline | Placebo comparator | Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins
AND
Isotonic saline for 10 mins (placebo) Receives: Other: Isotonic Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of headache and migraine
Incidence of PACAP38-induced headache and migraine-like attacks in patients with rosacea measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable") and international classification for migraine.
Measured: From 0 to 24 hours after infusion
Effect of sumatriptan
Severity of PACAP38-induced headache after pretreatment with sumatriptan in rosacea patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")
Measured: From 0 to 24 hours after infusion
Secondary outcomes (3)
Severity of flushing
Severity of PACAP38-induced flushing with and without sumatriptan-treatment measured by laser doppler flowmetry
Measured: From 0 to 4 hours after infusion
Facial temperature
PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography
Measured: From 0 to 4 hours after infusion
Superficial temporal artery diameter
Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound
Measured: From 0 to 4 hours after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start12 Nov 2018
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RosaceaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nita Katarina Frifelt Wienholtz, Danish Headache Center
- Investigators
- Messoud Ashina, MD,PhD,DMSc, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03878784
- Sponsor's protocol ID
- RosMigExperiment
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wienholtz NKF, Christensen CE, Coskun H, Zhang DG, Ghanizada H, Egeberg A, Thyssen JP, Ashina M. Infusion of Pituitary Adenylate Cyclase-Activating Polypeptide-38 in Patients with Rosacea Induces Flushing and Facial Edema that Can Be Attenuated by Sumatriptan. J Invest Dermatol. 2021 Jul;141(7):1687-1698. doi: 10.1016/j.jid.2021.02.002. Epub 2021 Feb 16.
PubMed 33600826
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
- Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea
- ClinicalTrials.gov ID
- NCT03878784
- Acronym / sponsor ID
- RosMigExperiment
- Conditions
- Rosacea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 18 Mar 2019 (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.
The investigators aim is to investigate the incidence of headache and rosacea-like flushing after pituitary adenylate cyclase-activating peptide-38 (PACAP38) with and without treatment with sumatriptan in patients with rosacea
Detailed description
Pituitary adenylate cyclase-activating peptide-38 (PACAP38) plays a role in rosacea pathophysiology. Infusions of PACAP38 can trigger migraine-like attacks in migraine patients. PACAP38 also induces flushing which may imitate rosacea-like flushing. We are investigating whether the flushing after PACAP38 resembles rosacea-like flushing, and whether treatment with sumatriptan has an effect on the headache and flushing effects of PACAP38.
The purpose of this study is to investigate PACAP38-induced headache and flushing in patients with rosacea who have been treated with either sumatriptan or placebo using purpose-developed standardized interview. The investigators will use a double-blind, placebo-controlled crossover study design to investigate this.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PACAP38 + Imigran | Active comparator | Drug: ImigranPituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Imigrane infusion (0.4 mg/min) for 10 mins |
| PACAP38 + Isotonic Saline | Placebo comparator | Other: Isotonic SalinePituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosed with rosacea
- weight between 50 - 100 kilograms
- women in fertile age must not be pregnant and must use adequate contraception
Key exclusion criteria (11 listed)
- migraine more than 5 days per month in average over the past year
- any primary headache other than migraine, apart from tension-type headache which must be less than 5 days per month
- headache < 48 hours before experimental day
- migraine < 72 hours before each experimental day
- daily / frequent use of any medication apart from contraceptive medication
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 |
|---|---|---|
| ImigranAlso: SumatriptanAll patients will undergo this intervention on one of two study days | Drug | PACAP38 + Imigran |
| Isotonic SalineAll patients will undergo this intervention on one of two study days | Other | PACAP38 + Isotonic Saline |
Primary outcome
Incidence of headache and migraine
Time frame: From 0 to 24 hours after infusion
Incidence of PACAP38-induced headache and migraine-like attacks in patients with rosacea measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable") and international classification for migraine.
Effect of sumatriptan
Time frame: From 0 to 24 hours after infusion
Severity of PACAP38-induced headache after pretreatment with sumatriptan in rosacea patients measured by numerical rating scale for pain from 0 ("no pain") to 10 ("worst pain imaginable")
3 secondary outcomes
Severity of flushing
Time frame: From 0 to 4 hours after infusion
Facial temperature
Time frame: From 0 to 4 hours after infusion
Superficial temporal artery diameter
Time frame: From 0 to 4 hours after infusion
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.
- Derived from this study: PubMed 33600826Wienholtz NKF, Christensen CE, Coskun H, Zhang DG, Ghanizada H, Egeberg A, Thyssen JP, Ashina M. Infusion of Pituitary Adenylate Cyclase-Activating Polypeptide-38 in Patients with Rosacea Induces Flushing and Facial Edema that Can Be Attenuated by Sumatriptan. J Invest Dermatol. 2021 Jul;141(7):1687-1698. doi: 10.1016/j.jid.2021.02.002. Epub 2021 Feb 16.
- 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.
Messoud Ashina, MD,PhD,DMSc principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imigran and Isotonic Saline in people with Rosacea, run by Danish Headache Center at 1 site in Denmark.
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 3 inclusion and 11 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 Denmark. 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.
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?
Incidence of headache and migraine (time frame: From 0 to 24 hours after infusion). The study lists 2 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 NCT03878784, 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 26 Mar 2020.