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

NCT04153188 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2022-03-31

Study results available
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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.

Conditions

  • Erythematotelangiectatic Rosacea

Interventions

DEVICE

The Vbeam® Prima System

3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.

DRUG

Oxymetazoline HCL 1% Cream

Daily application of Oxymetazoline HCL 1% cream for the 6-month study.

Sponsors & Collaborators

  • Candela Corporation

    lead INDUSTRY

Principal Investigators

  • Konika P Schallen, MD · Candela Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-15
Primary Completion
2020-11-13
Completion
2021-01-05
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04153188 on ClinicalTrials.gov