A trial by a Dr. Di Nardo using mice has found that cromolyn sodium ophthalmic solution 4% is able to reduce skin redness.
This small trial, which will be double blinded seeks to see whether the effect can be replicated in humans.
A total of 10 patients will be given either the saline vehicle or the cromolyn sodium ophthalmic solution.
This preparation forms the basis of the eye drops known as Crolom and Opticrom. It is known as a mast cell stablizer. They are typically used to prevent seasonal eye allergy symptoms such as itching, burning, watering, swelling, redness, or sensitivity to light.
Dr. Di Nardo was awarded a 2012 NRS Grant to study the role of “mast cells as a possible link between an overabundance of the antimicrobial peptides called cathelicidins in individuals with rosacea and the inflammation that appears on rosacea”.
Clinical Trial NCT01933464
An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
Sponsor: University of California, San Diego
Information provided by (Responsible Party): Anna Di Nardo, MD, PhD, University of California, San Diego
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.
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%.
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.
