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

Study Overview
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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).

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.

Official Title
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Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea- a Prospective Study

Conditions
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Rosacea

Intervention / Treatment
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* Drug: Bromonide 0.33% gel
* Device: Intense Pulsed Light (M22)


Participation Criteria
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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: Suffer from ETR Suffer from PPR 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment with bromonide 0.33% gel<br>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. | Drug: Bromonide 0.33% gel<br>* Patients would be treated with full face application of bromonide 0.33% gel once daily for three months.<br>|
| Active Comparator: Treatment with bromonide 0.33% gel & IPL<br>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. | Drug: Bromonide 0.33% gel<br>* Patients would be treated with full face application of bromonide 0.33% gel once daily for three months.<br>Device: Intense Pulsed Light (M22)<br>* Half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | six months after initiation of treatment compared to Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rosacea, Bromonidine, intensed pulse light