An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of California, San Diego
Sponsor:
Information provided by (Responsible Party):
Anna Di Nardo, MD, PhD, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT01933464
First received: August 21, 2013
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

This study is designed to investigate whether topical application of a cromolyn sodium solution is able to decrease the facial redness seen in patients with papulopustular rosacea. Previous work in the lab of Dr. Di Nardo on mice has suggested that cromolyn may be able to have this effect. The study will enroll a total of 10 patients. 5 will randomly be assigned to receive the cromolyn sodium solution, and the other 5 will be randomly assigned to receive the placebo solution. All participants will be instructed to apply their assigned solution twice daily to their face. Patients will return to the clinic 3, 6, and 8 weeks after the distribution of the solutions to measure the efficacy of their assigned solution.


Condition Intervention Phase
Papulopustular Rosacea
Drug: Cromolyn Sodium
Drug: Normal Saline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Facial erythema [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Facial erythema will be measured using the Clinician's Erythema Assessment applied to 5 areas of the subject's face (chin, nose glabella, left cheek, right cheek), as well as using measurements from a colorimeter applied to each of the 5 locations previous mentioned

  • Change in facial erythema [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    We will measure participants' change in facial erythema over the course of the study.


Secondary Outcome Measures:
  • Matrix Metalloproteinase levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Tape stripping methods will be used to determine matrix metalloproteinase levels

  • Change in matrix metalloproteinase levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    We will compare subjects' matrix metalloproteinase levels at the beginning of the study (baseline) to those at the end of the study (8 weeks after baseline)


Other Outcome Measures:
  • Adverse events [ Time Frame: Baseline, and then 3, 6 and 8 weeks after beginning study intervention ] [ Designated as safety issue: Yes ]
    Adverse events will be recorded at each visit and their likelihood to the study interventions will be recorded


Estimated Enrollment: 10
Study Start Date: August 2013
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cromolyn
Subjects in this arm will be asked to apply their assigned medication twice daily to their entire face. The medication they will be receiving is cromolyn sodium ophthalmic solution, 4%.
Drug: Cromolyn Sodium
Other Name: Crolom
Placebo Comparator: Vehicle
Participants in this group will be assigned a solution consisting of only the inactive ingredients in cromolyn sodium ophthalmic solution to apply to their entire face twice daily.
Drug: Normal Saline
Other Names:
  • 0.9% sodium chloride
  • NaCl

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or non-pregnant female, 18 - 80 years of age.
  • Subjects willing and able to give informed consent.
  • Subjects willing and able to comply with the requirements of the study.
  • Subject has the clinical diagnosis of at least mild erythema.
  • Subject has been on a stable dose for greater than 3 months of medications for treatment of concurrent medical condition (including oral contraceptive pills, vasodilators, adrenergic blocking agents) OR the investigator has determined that the medications are unlikely to affect the patient's rosacea and/or treatment during the study
  • Subject is in general good health in the opinion of the investigator.

Exclusion Criteria:

  • Subject has a diagnosis of Steroid Rosacea or Pyoderma Faciale (rosacea fulminans)
  • Subject has a history of Carcinoid, Pheochromocytoma, Serotonin Syndrome or other systemic flushing causes.

Subject has used facial topical therapies (OTC drug products or prescription products) for any reason within the prior 28 days

  • Subject has used systemic corticosteroid or systemic antibiotics (especially doxycycline, minocycline, tetracycline, metronidazole) within the prior 28 days.
  • Subject has had laser or light-based treatment for rosacea within the prior 3 months.
  • Subject has had systemic retinoids and retinoid derivatives over the past 6 months
  • Subject has any history of renal or hepatic insufficiency.
  • Subject has a known hypersensitivity or allergy to Cromolyn sodium or components of the vehicle.
  • Subject is pregnant or lactating or planning a pregnancy during the duration of the study
  • Subject has been treated with another investigational device or drug within 28 days prior to study enrollment or intends to participate in a clinical trial concurrent with this study
  • Subject has clinically significant findings, medical history or conditions (other than rosacea), which in the opinion of the Investigator may compromise the study, treatment protocol, or safety of the patient or treatment allocation.

Subject has a known hypersensitivity or allergy to tape or other adhesive materials

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933464

Contacts
Contact: Aimee Two, MD 858-657-8390 ucsddermstudies@gmail.com

Locations
United States, California
UCSD Division of Dermatology Recruiting
San Diego, California, United States, 92122
Contact: Aimee Two, MD    858-657-8390    ucsddermstudies@gmail.com   
Principal Investigator: Anna Di Nardo, MD, PhD         
Sponsors and Collaborators
University of California, San Diego
  More Information

No publications provided

Responsible Party: Anna Di Nardo, MD, PhD, MD, PhD (Associate Professor of Medicine), University of California, San Diego
ClinicalTrials.gov Identifier: NCT01933464     History of Changes
Other Study ID Numbers: 130199
Study First Received: August 21, 2013
Last Updated: August 28, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of California, San Diego:
Rosacea
Cromolyn sodium

Additional relevant MeSH terms:
Rosacea
Erythema
Skin Diseases
Cromolyn Sodium
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 11, 2014