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

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

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).

Study Overview

• Status: Withdrawn
• Conditions: Rosacea
• Intervention / Treatment: Drug: Bromonide 0.33% gel; Device: Intense Pulsed Light (M22)

Detailed Description

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• Israel
  • Petaẖ Tiqwa, Israel
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Assi Levi, Dr., Rabin Medical center, Petach Tikva

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): January 2, 2019
• Study Completion (Actual): January 2, 2019

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 12, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2022
• Last Update Submitted That Met QC Criteria: October 27, 2022
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Rosacea, Bromonidine, intensed pulse light
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea
• Other Study ID Numbers: 0682-16RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No