Clinical Trial Review

Rosacea is a common disease characterized by inflammation and vascular abnormalities of the facial skin and ocular surface. It it considered to be a syndrome encompassing various combinations of cutaneous signs, including flushing, erythema, telangiectasia, papules, edema, ocular lesions, and rhinophyma. The exact etiology of cutaneous rosacea is unknown, but it is characterized by persistent vasodilation, increased vascular permeability, and vascular hyper-reactivity of the microcirculation of the central part of the face. The purpose of this study is to develop gene expression profiles of papulopustular rosacea compared with those of normal skin. The investigator hopes to better understand the abnormal gene functions that might contribute to this condition. This understanding may lead to the development of additional and better treatments for rosacea.

Topical therapy is not always effective in treating symptoms of rosacea. Furthermore, rapid recurrence is common following the use of systemic antibiotics, resulting in the chronic use of these medications to control the disease. Although the exact pathogenesis of rosacea is unknown, treatment for this condition has been investigated based on its similarity to acne and photodamaged skin. Case reports have shown promising results in rosacea patients treated with methyl aminolevulinate photodynamic therapy (MAL-PDT). Other than a case report which observed significant improvement of papules, pustules, erythema, and flushing following 5 - aminolevulinic acid photodynamic therapy (ALA-PDT) treatment of a patient with rosacea, the role of ALAPDT in the treatment of rosacea has not been reported.

This pilot study is investigating the efficacy of ALA-PDT in treating papulopustular rosacea. The objectives of the study are as follows:

To evaluate improvement of the inflammatory lesions (papules, pustules, nodules), erythema, and telangiectasia of rosacea as assessed by the Investigator’s Global Assessment.

To evaluate improvement of the inflammatory lesions of rosacea as assessed by the Inflammatory Lesion Investigator’s Global Assessment.

An investigator-blinded, prospective, 6-month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.

Subjects with persistent erythema associated with rosacea will be recruited from the Wake Forest Baptist Health Dermatology Clinics and Institutional Review Board (IRB)-approved advertising. Subjects will be classified as having erythematotelangiectatic or a combination of erythematotelangiectatic and papulopustular. If they agree to participate, subjects will give written consent approved by the IRB and will be seen in follow up at months 3 and 6. The investigator is also interested in learning through the adherence surveys if subjects begin using the medication on an as needed basis, and if this affects the side effect profile and satisfaction with the medication.