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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
10
UCSD Division of Dermatology
San Diego, California, United States
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.
Time frame: 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.
Time frame: Baseline and 8 weeks
Matrix Metalloproteinase Activity Levels
Tape stripping methods were used to isolate matrix metalloproteinase(MMP). Total-MMP activity was determined with total-MMP fluorogenic substrate (5 μM; Enzo Life Sciences), in protein extracts, and subsequently measuring activity (Vmax/sec) at a fluorescence excitation wavelength 328 nm and an emission wavelength of 400 nm in a fluorescence plate reader (Gemini EM microplate spectrofluorometer).
Time frame: Baseline
Change in Matrix Metalloproteinase Activity
We will compare subjects' matrix metalloproteinase activity levels at the beginning of the study (baseline) to those at the end of the study (8 weeks after baseline). Tape stripping methods were used to isolate matrix metalloproteinase(MMP). Total-MMP activity was determined with total-MMP fluorogenic substrate (5 μM; Enzo Life Sciences), in protein extracts, and subsequently measuring activity (Vmax/sec) at a fluorescence excitation wavelength 328 nm and an emission wavelength of 400 nm in a fluorescence plate reader (Gemini EM microplate spectrofluorometer).
Time frame: Baseline and 8 weeks
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