PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea
- Registration Number
- NCT03878784
- Lead Sponsor
- Danish Headache Center
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
- diagnosed with rosacea
- weight between 50 - 100 kilograms
- women in fertile age must not be pregnant and must use adequate contraception
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PACAP38 + Isotonic Saline Isotonic Saline Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo) PACAP38 + Imigran Imigran Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Imigrane infusion (0.4 mg/min) for 10 mins
- Primary Outcome Measures
Name Time Method Incidence of headache and migraine 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 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")
- Secondary Outcome Measures
Name Time Method Severity of flushing From 0 to 4 hours after infusion Severity of PACAP38-induced flushing with and without sumatriptan-treatment measured by laser doppler flowmetry
Facial temperature From 0 to 4 hours after infusion PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography
Superficial temporal artery diameter From 0 to 4 hours after infusion Superficial temporal artery diameter after PACAP38 with and without sumatriptan-treatment measured by ultrasound
Trial Locations
- Locations (1)
DanishHC
🇩🇰Glostrup, Denmark
DanishHC🇩🇰Glostrup, Denmark