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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878784
• Other study ID #: RosMigExperiment
• Status: Completed
• Phase: N/A
• Start date: November 12, 2018
• Est. completion date: December 19, 2019

Study information

• Verified date: March 2020
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Headache
• Rosacea

Intervention

Drug:
• Imigran
All patients will undergo this intervention on one of two study days

Other:
• Isotonic Saline
All patients will undergo this intervention on one of two study days

Locations

Country	Name	City	State
Denmark	DanishHC	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Facial temperature	PACAP38-induced temperature changes with and without sumatriptan-treatment measured by infrared thermography	From 0 to 4 hours after infusion
Secondary	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