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

• Sponsor: Danish Headache Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03878784
• Collaborator: (none)
• Enrollment: 38
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.2
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Rosacea	Drug: Imigran; Other: Isotonic Saline	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind
• Primary Purpose: Treatment
• Official Title: Investigation of PACAP38-induced Headache and Rosacea-like Symptoms in Patients With Rosacea
• Actual Study Start Date: Nov 12, 2018
• Actual Primary Completion Date: Dec 19, 2019
• Actual Study Completion Date: Dec 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: PACAP38 + 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	Drug: Imigran; All patients will undergo this intervention on one of two study days; Other Names: Sumatriptan
Placebo Comparator: PACAP38 + Isotonic Saline Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo)	Other: Isotonic Saline; All patients will undergo this intervention on one of two study days

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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

1. 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

2. Facial temperature [From 0 to 4 hours after infusion]

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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DanishHC	Glostrup		Denmark	DK-2600

Sponsors and Collaborators

• Danish Headache Center

Investigators

• Principal Investigator: Messoud Ashina, MD,PhD,DMSc, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nita Katarina Frifelt Wienholtz, Principal Investigator, Medical Doctor, PhD Student, Danish Headache Center
• ClinicalTrials.gov Identifier: NCT03878784
• Other Study ID Numbers: RosMigExperiment
• First Posted: Mar 18, 2019
• Last Update Posted: Mar 26, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Rosacea; Headache; Sumatriptan

Study Results

No Results Posted as of Mar 26, 2020