Clinical Trial Review
July 2016 | Volume 15 | Issue 7 | Features | 901 | Copyright © July 2016
Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform
the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To
participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.
Genetic Basis of Rosacea Study
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.
Photodynamic Therapy for Papulopustular 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
Internet Surveys and Their Impact on Adherence to
Brimonidine Topical Gel and Quality of Life in Patients
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.