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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2019-01-02

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Rosacea

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

This is an interventional, prospective single blinded study. 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Physicians will perform assessment of clinical outcome, using clinical photographs .These physicians will be blinded to which half of the face was treated with intense pulsed light.

Study Groups

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Treatment with bromonide 0.33% gel

Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. Half of the patients' face would recieve this treatment alone.

Group Type ACTIVE_COMPARATOR

Bromonide 0.33% gel

Intervention Type DRUG

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

Treatment with bromonide 0.33% gel & IPL

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

Group Type ACTIVE_COMPARATOR

Bromonide 0.33% gel

Intervention Type DRUG

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

Intense Pulsed Light (M22)

Intervention Type DEVICE

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

Interventions

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Bromonide 0.33% gel

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

Intervention Type DRUG

Intense Pulsed Light (M22)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No