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

Phase 4

Withdrawn

• Conditions: Rosacea
• Interventions: Drug: Bromonide 0.33% gel; Device: Intense Pulsed Light (M22)

• Registration Number: NCT03053700
• Lead Sponsor: Rabin Medical Center

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-02-06
• Study First Submitted QC: 2017-02-12
• Study First Posted: 2017-02-15
• Status Verified: 2018-09
• Study Start: 2018-12-01
• Primary Completion: 2019-01-02
• Study Completion: 2019-01-02
• Last Update Submitted: 2022-10-27
• Last Update Posted: 2022-10-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with bromonide 0.33% gel	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.
Treatment with bromonide 0.33% gel & IPL	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 be subjected to three IPL treatment sessions three weeks apart from each other.
Treatment with bromonide 0.33% gel & IPL	Intense Pulsed Light (M22)	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.

Primary Outcome Measures

Name	Time	Method
patient self-assessment questionaires score change	six months after initiation of treatment compared to Baseline	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.
Physicians' unblinded score assessment	six months after initiation of treatment compared to Baseline	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.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petaẖ Tiqwa, Israel