PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Imigran
* Other: Isotonic Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosed with rosacea weight between 50 - 100 kilograms women in fertile age must not be pregnant and must use adequate contraception Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PACAP38 + Imigran<br>Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Imigrane infusion (0.4 mg/min) for 10 mins | Drug: Imigran<br>* All patients will undergo this intervention on one of two study days<br>* Other names: Sumatriptan;|
| Placebo Comparator: PACAP38 + Isotonic Saline<br>Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo) | Other: Isotonic Saline<br>* All patients will undergo this intervention on one of two study days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | From 0 to 24 hours after infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of flushing | Severity of PACAP38-induced flushing with and without sumatriptan-treatment measured by laser doppler flowmetry | From 0 to 4 hours after infusion | 
| Facial temperature | PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography | 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 | From 0 to 4 hours after infusion |