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Capsaicin in Treatment of Rhinogenic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03330639
Recruitment Status : Not yet recruiting
First Posted : November 6, 2017
Last Update Posted : May 8, 2020
Information provided by (Responsible Party):
Karli Davis, University of Nebraska

Brief Summary:
Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects. This study aims to evaluate capsaicin impact on headaches attributed to V1, V2 distribution of the sinonasal cavity. This study is a randomized, double-blinded, parallel trial.

Condition or disease Intervention/treatment Phase
Headache Disorders Other: Capsaicin Other: Placebo Not Applicable

Detailed Description:
  1. Title: The role of capsaicin in treatment of rhinogenic headache
  2. Description: Capsaicin (8- methyl-N-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. We hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. This study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution.
  3. Interventions, evaluations, and follow-up: Subjects are recruited from an Otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. Written instructions are provided and consent obtained. A symptom journal is provided. Subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. They are instructed to use the nasal spray one to two times daily. Subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. The journal is completed daily, and includes medication use, a headache pain score, and side effect log. Additionally, subjects fill out SinoNasal Outcome test (SNOT)22 at 2 weeks, 4 weeks, and 8 weeks. Weekly emails are sent to remind subject to fill out their journal. A phone call is made to the subject to survey them on progress at 2 and 6 weeks. Follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. A standard nasal endoscopy is performed at the first and last visit.
  4. Additional data that would be tracked: Quality of life score as measured by SNOT-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized parallel group
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Role of Topical Capsaicin in Treatment of Rhinogenic Headache
Estimated Study Start Date : July 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache
Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: Experimental Group
This group will receive the capsaicin. The Study Drug ICX72 or sinus buster which is a homeopathic blend of capsicum annum and eucalyptol, that is readily available over the counter.
Other: Capsaicin
Capsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA.

Placebo Comparator: Placebo Group
This group will receive saline. The Placebo formulation contained saline and eucalyptol in a concentration that matched the control.
Other: Placebo
This group will receive the saline placebo solution.

Primary Outcome Measures :
  1. headache medication use [ Time Frame: 1 year ]
    We will track the amount of headache medication used during the study period

Secondary Outcome Measures :
  1. number of patients with treatment related adverse events [ Time Frame: 1 year ]
    patients will be asked to report any adverse reactions or events during the study period.

  2. headache frequency and severity [ Time Frame: 1 year ]
    Patient will be asked to record the number of headaches during the study period, and record the severity from 1-10 on the Visual Analog Scale (VAS)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Consenting Adults aged 19-100 presenting to the Otolaryngology DepartmentofUniversityof Nebraska Medical center complaining of headaches/ facial pain and pressure Diagnosis of a primary rhinogenic headache disorder by the senior authors.

Exclusion Criteria:

  • Exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed Temporal Mandibular Joint (TMJ) arthralgia as the etiology of primary headache.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03330639

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Contact: Christie Barnes, MD 4025597978
Contact: Karli Davis, MPH 4025597978

Sponsors and Collaborators
University of Nebraska
Additional Information:
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Responsible Party: Karli Davis, PI, University of Nebraska Identifier: NCT03330639    
Other Study ID Numbers: 511-17
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided if sharing IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache Disorders
Neurologic Manifestations
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs