PATIENT-RATED IMPACT ASSESSMENT FOR ROSACEA FACIAL REDNESS (IA-RFR)- RESULTS OF TWO PHASE 3 PIVOTAL TRIALS OF OXYMETAZOLINE CREAM 1% VS VEHICLE

Author(s)

Ferrusi IL1, Ahluwalia G1, Andrae DA2
1Allergan plc, Irvine, CA, USA, 2Allergan plc, Austin, TX, USA

OBJECTIVES:  Persistent erythema associated with rosacea has considerable psychological and social impacts that are important to assess when evaluating treatment efficacy. Two phase 3 pivotal trials examined efficacy and safety of oxymetazoline for treatment of moderate to severe persistent facial erythema associated with rosacea. This report describes Impact Assessment for Rosacea Facial Redness (IA-RFR) outcomes from both trials. METHODS:  In 2 identically designed trials (REVEAL 1 and 2), eligible patients were randomized 1:1 to vehicle or oxymetazoline hydrochloride cream 1.0% (oxymetazoline) applied to the face (QD, 29 days). The impact of erythema associated with rosacea was evaluated using the 8-item IA-RFR, a validated, patient-rated scale. Each item was rated on a 5-point scale (0–4; higher scores indicate more negative impact). Patients completed the IA-RFR at baseline and at hour 6 on follow-up days 1, 15, and 29. Differences between oxymetazoline-group and vehicle-group changes from baseline in IA-RFR total score and Self-perception, Emotional functioning, personal Grooming, and Social functioning domain scores were compared using the van Elteren test. Analyses of item-level changes are ongoing. RESULTS:  IA-RFR assessments included 440 patients in REVEAL 1 (oxymetazoline, n=222; vehicle, n=218) and 443 patients in REVEAL 2 (oxymetazoline, n=223; vehicle, n=220). In REVEAL 1, median change from baseline to day 29 was significantly greater with oxymetazoline vs vehicle for total IA-RFR (−0.60 vs −0.50; P=0.045), personal Grooming (−0.50 vs 0.00; P=0.021), and 1 Self-perception item (self-consciousness; −1.0 vs −1.0; P=0.024). In REVEAL 2, median change from baseline to day 29 was numerically greater for oxymetazoline vs vehicle for the total IA-RFR score (−0.70 vs −0.60). Pooled data analyses are forthcoming. CONCLUSIONS:  Patients with moderate to severe persistent facial erythema associated with rosacea reported greater improvements in impacts of rosacea facial redness when treated with oxymetazoline compared with patients who received vehicle.

Conference/Value in Health Info

2017-05, ISPOR 2017, Boston, MA, USA

Value in Health, Vol. 20, No. 5 (May 2017)

Code

PSS26

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Sensory System Disorders

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