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

NCT01933464 | Completed Phase 1 Results

• 1 other identifier: 130199
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Papulopustular Rosacea

Keywords

Rosacea; Cromolyn sodium

Outcome Measures

Primary Outcomes (2)

• Facial Erythema

  Facial erythema will be measured using the Clinician's Erythema Assessment(CEA) 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. Each area is rated from 0-4, where 4 represents the most facial erythema (worst outcome). The scores for the 5 locations are summed with a CEA total score scale of 0-20.

  Baseline

• Change in Facial Erythema

  We will measure participants' change in facial erythema over the course of the study. The change in facial erythema is measured as a difference between the final (8 weeks after baseline) and baseline visit of the sum of the CEA scores determined from the 5 designated locations (nose, glabella, left cheek, right cheek, and chin). The scale range from -20 to 20. A negative score indicates improvement of facial erythema from baseline to 8 weeks after baseline. A positive score indicates worsening of facial erythema from baseline to 8 weeks after baseline.

  Baseline and 8 weeks

Secondary Outcomes (2)

• Matrix Metalloproteinase Activity Levels

  Baseline

• Change in Matrix Metalloproteinase Activity

  Baseline and 8 weeks

Other Outcomes (1)

• Adverse Events

  Baseline, and then 3, 6 and 8 weeks after beginning study intervention

Study Arms (2)

Cromolyn

EXPERIMENTAL

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

Vehicle

PLACEBO COMPARATOR

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

Interventions

Cromolyn Sodium DRUG

Also known as: Crolom

Cromolyn

Normal Saline DRUG

Also known as: 0.9% sodium chloride, NaCl

Vehicle

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Division of Dermatology

San Diego, California, 92122, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Cromolyn Sodium; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dermatology Clinical Trial Manager
• Organization: UCSD Dermatology Clincal Trials

dermstudies@ucsd.edu

(858)657-8390

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD (Associate Professor of Medicine)

Study Record Dates

• First Submitted: August 21, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 7, 2019
• Results First Posted: July 30, 2019

Record last verified: 2019-07

Locations

US (1)