Clinical trial NCT03878784: PACAP38 Induced Headache and Rosacea-like Symptoms in Patients With Rosacea
Official title: Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rosacea
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of headache and migraine
timeFrame: From 0 to 24 hours after infusion
measure: Effect of sumatriptan
timeFrame: From 0 to 24 hours after infusion
Secondary outcomes:
measure: Severity of flushing
timeFrame: From 0 to 4 hours after infusion
measure: Facial temperature
timeFrame: From 0 to 4 hours after infusion
measure: Superficial temporal artery diameter
timeFrame: From 0 to 4 hours after infusion
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: DanishHC
Study officials:
affiliation: Professor
name: Messoud Ashina, MD,PhD,DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.