Pulsed Dye Laser Treatment and Oxymetazoline Hydrochloride (HCL) 1% Cream for Erythematotelangiectatic Rosacea

Erythematotelangiectatic Rosacea Clinical Trial

Official title: Pilot Study to Evaluate Vbeam® Prima Pulsed Dye Laser (PDL) Treatment and RHOFADE® (Oxymetazoline HCL, 1% Cream) for Erythematotelangiectatic Rosacea

Status Completed

Clinical Trial Summary

This study will compare treatment outcome with pulsed dye laser, when used used as an adjunctive treatment to oxymetazoline HCl 1% cream, compared to oxymetazoline HCL 1% cream alone, for patients with moderate or severe erythematotelangiectatic rosacea.

Clinical Trial Description

This is a prospective, two-arm randomized, baseline-controlled, pilot study to evaluate treatment outcome of 3 Vbeam® Prima PDL treatments in subjects applying once-daily RHOFADE® topical oxymetazoline HCL 1.0% cream for improvement in erythematotelangiectatic rosacea. Treatment outcome will be compared to oxymetazoline HCL 1% cream alone.

Subjects with moderate or severe (Grade 3 or 4) erythematotelangiectatic rosacea on the validated Clinical Erythema Assessment (CEA) Scale and Subject Self-Assessment (SSA) Scale will be enrolled and randomized to one of two study arms:

Arm 1- 3 monthly treatments with Vbeam® PDL with daily RHOFADE® topical oxymetazoline HCL 1.0% cream.

Arm 2 -Treatment with daily RHOFADE® topical oxymetazoline HCL 1.0% cream only.

All subjects will apply RHOFADE® cream daily during the 6-month study. After 1-month of RHOFADE® cream, subjects in the combined treatment Arm 1 will receive the first of three monthly Vbeam® PDL treatments (at 4-week intervals) with a 3-day washout of cream before each treatment.

Investigators will assess erythema severity, global aesthetic improvement and vessel size improvement with treatment at 1, 2, 3 and 6-months' post-baseline. Subject satisfaction will be assessed. Safety assessments will be conducted at each study visit, and subjects in Arm 1 will also be assessed for treatment-associated discomfort and post-treatment response following PDL treatments. ;

Related Conditions & MeSH terms

• Erythematotelangiectatic Rosacea
• Rosacea

• NCT number: NCT04153188
• Study type: Interventional
• Source: Candela Corporation
• Status: Completed
• Phase: Phase 4
• Start date: January 15, 2019
• Completion date: January 5, 2021