Clinical trial: An Analysis of the Effect of Topical Cromolyn Sodium on Rosacea-associated Erythema (NCT01933464)

Eligibility 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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 41-year-old woman comes to the dermatology clinic complaining of facial redness, especially on her forehead and cheeks. She noticed that the redness gets worse in the summer and after sun exposure. She is otherwise healthy. On physical examination, she has multiple papules and pustules present on her forehead, cheeks, and nose on a background of erythema and telangiectasias. There are no other lesions or nodules. The patient is married and has 2 children who are 5 and 9 years old. She has IUD and doesn't wish to have more kids. She does not smoke or drink alcohol. Her vital signs are normal, and BMI is 21.

Patient description (patient's own words): I'm 41, married with 2 lovely kids who are 5 and 9 years old. I have an IUD and I don't want to have more kids. I don't smoke or drink alcohol. I had to go to the dermatology clinic because I had terrible redness on my face, especially on my forehead and cheeks. It got worse in the summer and after being under the sun. I'm usually healthy. They conducted a physical exam and they found several lesions and pustules on my forehead, cheeks and nose and they also found some signs of erythema and telangiectasia. My vitals were normal, and my BMI is 21.

Does the patient match the trial criteria? Entailment