A Randomized Controlled Pilot Study: Combined 595-nm Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride Topical Cream Superior to Oxymetazoline Hydrochloride Cream for Erythematotelangiectatic Rosacea

Pooja Sodha, Amanda Suggs, Girish S Munavalli, Paul M Friedman, Pooja Sodha, Amanda Suggs, Girish S Munavalli, Paul M Friedman

Abstract

Background and objectives: We evaluated if oxymetazoline therapy combined with 595-nm pulsed dye laser (PDL) will be more beneficial than topical oxymetazoline alone for the improvement of erythematotelangiectatic rosacea.

Study design/materials and methods: This was a randomized, controlled, prospective clinical trial approved by an independent Institutional Review Board, which enrolled 34 patients with moderate to severe clinical erythema (CEA) into a two-arm study of PDL with concomitant oxymetazoline cream (Arm 1) and oxymetazoline cream alone (Arm 2). Patients in Arm 1 were treated with 3 monthly laser sessions, which were started after 1 month of topical oxymetazoline cream. Thirty subjects continued with the study, and 25 subjects (Arm 1: 14, Arm 2: 11) completed the 6-month follow-up. With photographic comparison to baseline images, efficacy endpoints were based on clinical on-site grading by both the investigator and the patient, using the grading tools for CEA, Global Aesthetic Improvement (GAI) assessment, vessel size improvement, and subject self-assessment. These scales were assessed at baseline and/or at each clinical follow-up at 1, 2, 3, and 6 months. Subject satisfaction as well as post-treatment immediate response and treatment-associated pain scores were also evaluated.

Results: Statistically significant improvement in CEA was seen in both arms at the 1-, 2-, and 3-month post-baseline visits (P < 0.01). Only Arm 1 presented statistically significant improvement in CEA (P < 0.001) at 6 months post baseline with a mean score of 1.6 (almost clear-mild) compared with 3.2 at baseline. Arm 1 showed significantly greater mean vessel size improvement at 3 months (P < 0.01) and 6 months (P < 0.05) post baseline compared to Arm 2. Significantly greater improvement (P < 0.05) in the investigator GAI score was reported at the 2- and 6-month follow-ups compared with Arm 2. Subject GAI scores showed statistically significant greater improvement in Arm 1 compared with Arm 2 at both the 3- and 6-month follow-ups (P < 0.01). There were no complications or long-term effects associated with PDL or topical oxymetazoline treatments.

Conclusion: The prospective trial verifies a safe, enhanced clinical outcome with the combination of PDL therapy and topical oxymetazoline for the treatment of erythematotelangiectatic rosacea patients. Lasers Surg. Med. © 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Trial registration: ClinicalTrials.gov NCT04153188.

Keywords: oxymetazoline; pulsed dye laser; rosacea.

© 2021 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Figures

Figure 1
Figure 1
Study visits flowchart. Baseline assessments were performed on Day 0. Following 4 weeks of oxymetazoline therapy and a 3‐day washout period, subjects in Arm 1 received three PDL treatments at 3–5 weeks intervals.
Figure 2
Figure 2
Consortium diagram randomization scheme. One subject in the combined therapy Arm 1 withdrew prior to the 1‐month follow‐up. Three subjects in Arm 2 withdrew prior to the 1‐month follow‐up: one subject could not comply with study visits, one subject requested withdrawal and one subject experienced skin reaction to topical oxymetazoline cream and withdrew. Of the 30 subjects who continued with the study, 25 subjects (Arm 1, n = 14; Arm 2, n = 11) completed the 6‐month follow‐up. PDL, pulsed dye laser; TX, treatment.
Figure 3
Figure 3
Baseline and 6‐month post‐baseline: patient treated with PDL and topical oxymetazoline and subsequent two‐grade improvement in CEA score (3–1). CEA, clinical erythema assessment; PDL, pulsed dye laser.
Figure 4
Figure 4
Baseline and 6‐month post‐baseline: patient treated with PDL and topical oxymetazoline and subsequent three‐grade improvement in CEA score (3‐0). CEA, clinical erythema assessment; PDL, pulsed dye laser.
Figure 5
Figure 5
Baseline and 6‐month post‐baseline: patient treated with topical oxymetazoline only and subsequent three‐grade improvement in CEA score (4‐1). CEA, clinical erythema assessment.

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Source: PubMed

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