Content provided in partnership with

Pharma Industry

The Face and Mind Evaluation study: an examination of the efficacy of rosacea treatment using physician ratings and patients' self-reported quality of life

Journal of Drugs in Dermatology, Sept-Oct, 2005 by Alan Fleischer, Suephy Chen

Abstract

Objective: To examine both the short-term clinical efficacy and quality-of-life changes resulting from treatment of rosacea with regimens that reflect the participating physicians' standards of care while incorporating azelaic acid gel.

Design: Longitudinal, open-label, observational study.

Patients: 583 patients with mild to moderate rosacea participated in this study.

Interventions: Patients received azelaic acid gel either alone or in combination with other standard treatment for rosacea according to each participating physician's standards of care.

Most Popular Articles in Health: Fuel your workout: exercisers who eat before they work out have more energy ...; Soothe a dry, itchy scalp: 5 easy expert solutions; Cocktails and calories: Beer, wine and liquor calories can really add up. ...; The sour truth about apple cider vinegar - evaluation of therapeutic use; The, six best supplements you've never heard of: these secret weapons can ...; More »

Main Outcome Measures: Change in Investigator's Global Assessment score, measuring the severity of rosacea symptoms, from baseline to follow-up, and change in scores on the RosaQoL[TM], a rosacea-related quality-of-life instrument with 4 component measures (Overall, Emotion, Symptom, and Function) completed by patients at both baseline and follow-up.

Results: Over the course of treatment, the mean Investigator's Global Assessment score dropped from 3.52 to 2.10 (P < .0001). Patients who were prescribed combination therapy had significantly greater improvement than those who were prescribed azelaic acid gel alone (P < .0001). All 4 components of the RosaQoL[TM] also showed significant improvement over the course of treatment, regardless of the type of therapy prescribed (P < .0001).

Conclusion: Azelaic acid gel, either alone or in combination with other medications, is efficacious in the treatment of mild to moderate rosacea, as shown by observational data collected in the clinical setting from both treating physicians and patients.

Introduction

Rosacea is a chronic, predominantly centrofacial dermatosis, characterized by inflammatory papules and pustules, persistent erythema, telangiectasia, skin hyper-reactivity, and a burning sensation. (1) In addition to causing physiologic symptoms, the condition severely impacts quality of life by affecting self-esteem, emotional state, and professional and social relationships.

Several treatments are currently available for the treatment of rosacea, including oral/topical antibiotics, topical sulfacetamides/sulfurs, metronidazole, and commercial cleansers. (2,3) Azelaic acid 15% gel (AzA gel) is the first new topical treatment for mild to moderate rosacea to become available in more than a decade. AzA gel has been proven effective in the treatment of papulopustular facial rosacea in 2 pivotal, phase 3, vehicle-controlled studies, (4,5) and has demonstrated superior efficacy in reducing inflammatory lesions and erythema severity versus 0.75% metronidazole gel in a comparative study. (6,7) These studies have shown the short-term effectiveness of AzA gel in reducing the symptoms of rosacea; a study to examine the effectiveness of AzA gel in maintaining positive results is currently in progress.

The Face and Mind Evaluation (FAME) examines both the clinical efficacy and the quality-of-life changes resulting from treatment of rosacea with regimens that reflect the participating physicians' standards of care while incorporating AzA gel. This represents a real-world, practice-based evaluation of AzA gel, with the additional consideration of the treatment's effect on the patient's quality of life.

Quality of life represents an important outcome parameter to measure in the care of dermatology patients, as the majority of the conditions that dermatologists treat are not life-threatening. There are many quality-of-life measures used in dermatology, ranging from disease-specific to skin-specific, and general health. The more general the instrument, the more it is applicable across different populations. However, the general instruments may not contain relevant items specific to a particular disease. Disease-specific measures are based upon concerns that are most relevant to the disease in question, and are thus more sensitive and more likely to detect responsiveness.

RosaQoL[TM] is a rosacea-specific quality-of-life instrument based upon in-depth interviews with rosacea patients. (8) The instrument contains 21 items that ask about the frequency with which a particular aspect of living with rosacea affects the patient, ranging from "never" to "always." The items are categorized into 3 constructs: symptom, emotion, and function. Subscale scores are calculated for each construct, along with an overall score. Each question asks about the frequency with which a particular aspect of living with rosacea affects the patient. The RosaQoL[TM] instrument has been validated and shown to be reliable.

Methods

Study Design and Patients

This longitudinal, open-label, observational study was designed to examine the efficacy of short-term rosacea treatment in the clinical setting. Eligibility requirements for the study included men and women with mild to moderate rosacea for whom their physicians believed AzA gel, either alone or in combination with oral or other topical treatments, was appropriate. Each participating physician was allowed to enroll up to 4 patients. Women who were pregnant, contemplating pregnancy, or breast-feeding were excluded from the study. Although AzA gel is a pregnancy category B drug, and thus safe for use during pregnancy, some of the additional medications prescribed for patients receiving combination therapy could potentially have been unsuitable for use in pregnant women. In addition, patients with severe rosacea not appropriate for topical treatment with AzA gel (eg, those with phymatous or ocular rosacea) were excluded from the study.

Pharma Industry

The Face and Mind Evaluation study: an examination of the efficacy of rosacea treatment using physician ratings and patients' self-reported quality of life

Journal of Drugs in Dermatology, Sept-Oct, 2005 by Alan Fleischer, Suephy Chen

Find Research Guides for:

Find Featured Titles for: Business

Most Popular Articles in Health

Most Popular Publications in Health