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

Not Applicable
Completed
Conditions
Rosacea
Interventions
Other: Isotonic Saline
Drug: Imigran
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
Inclusion Criteria
  • diagnosed with rosacea
  • weight between 50 - 100 kilograms
  • women in fertile age must not be pregnant and must use adequate contraception
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PACAP38 + Isotonic SalineIsotonic SalinePituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo)
PACAP38 + ImigranImigranPituitary 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
NameTimeMethod
Incidence of headache and migraineFrom 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 sumatriptanFrom 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
NameTimeMethod
Severity of flushingFrom 0 to 4 hours after infusion

Severity of PACAP38-induced flushing with and without sumatriptan-treatment measured by laser doppler flowmetry

Facial temperatureFrom 0 to 4 hours after infusion

PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography

Superficial temporal artery diameterFrom 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
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