An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema
| Status: | Recruiting |
|---|---|
| Conditions: | Cosmetic, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | August 2013 |
| Contact: | Aimee Two, MD |
| Email: | ucsddermstudies@gmail.com |
| Phone: | 858-657-8390 |
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.
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.
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
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