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

NCT03878784 | Completed DMC

• 1 other identifier: RosMigExperiment
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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

Conditions

Rosacea

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Severity of flushing

  From 0 to 4 hours after infusion

• Facial temperature

  From 0 to 4 hours after infusion

• Superficial temporal artery diameter

  From 0 to 4 hours after infusion

Study Arms (2)

PACAP38 + Imigran

ACTIVE COMPARATOR

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

PACAP38 + Isotonic Saline

PLACEBO COMPARATOR

Pituitary adenylate cyclase-activating peptide-38 infusion (10 picomol/kg/min) for 20 mins AND Isotonic saline for 10 mins (placebo)

Other: Isotonic Saline

Interventions

Imigran DRUG

All patients will undergo this intervention on one of two study days

Also known as: Sumatriptan

PACAP38 + Imigran

Isotonic Saline OTHER

All patients will undergo this intervention on one of two study days

PACAP38 + Isotonic Saline

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• diagnosed with rosacea
• weight between 50 - 100 kilograms
• women in fertile age must not be pregnant and must use adequate contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

DanishHC

Glostrup Municipality, DK-2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 33600826 DERIVED

MeSH Terms

Conditions

Rosacea

Interventions

Sumatriptan; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Messoud Ashina, MD,PhD,DMSc

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor, PhD Student

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: March 18, 2019
• Study Start: November 12, 2018
• Primary Completion: December 19, 2019
• Study Completion: December 19, 2019
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)