Rosacea
Conditions
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.
Interventions
DRUGImigran
All patients will undergo this intervention on one of two study days
OTHERIsotonic Saline
All patients will undergo this intervention on one of two study days
Sponsors
Danish Headache Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed