Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea

Rabin Medical Center

Overview

This is an interventional and prospective study. The study is designed to evaluate the additional benefits of a combination of IPL treatment and local application of Bromonide 0.33% gel in the treatment of erythematotelangiectatic (ETR) and papulopustular (PPR).

Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. In addition half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Rosacea

Interventions

Bromonide 0.33% gelDRUG

Patients would be treated with full face application of bromonide 0.33% gel once daily for three months.

Intense Pulsed Light (M22)DEVICE

Half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patient (male or female) must be over 18 yaers old of age and fulfil one of the following: 1. Suffer from ETR 2. Suffer from PPR 3. Suffer from a combination of ETR and PPR. Exclusion Criteria: * 1.Under 18 years old of age. 2.Pregnant women. 3.Systemic treatment of rosacea at the previous six months before enrollment. 4.Topical treatment of rosacea at the previous one month before enrollment. 5.Phymatous or occular rosacae.

Locations (1)

Rabin Medical Center

Petah Tikva, Israel

Outcomes

Primary Outcomes

patient self-assessment questionaires score change

Patient will assess disease change on 5 points scale (0=no improvement, 1=0-25% improvement, 2=26-49% improvement, 3=50-74% improvement, 4= 75-100% improvement.

Time frame: three months after initiation of treatment compared to Baseline

Physicians' unblinded score assessment

Physician will assess disease change on 5 points scale (0=no improvement, 1=0-25% improvement, 2=26-49% improvement, 3=50-74% improvement, 4= 75-100% improvement.

Time frame: three months after initiation of treatment compared to Baseline

Physicians' unblinded score assessment

Physician will assess disease change on 5 points scale (0=no improvement, 1=0-25% improvement, 2=26-49% improvement, 3=50-74% improvement, 4= 75-100% improvement.

Time frame: six months after initiation of treatment compared to Baseline

patient self-assessment questionaires score change

Patient will assess disease change on 5 points scale (0=no improvement, 1=0-25% improvement, 2=26-49% improvement, 3=50-74% improvement, 4= 75-100% improvement.

Time frame: six months after initiation of treatment compared to Baseline

Data from ClinicalTrials.gov

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