Back to resultsIntense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea
Primary Purpose
Rosacea
Status
Withdrawn
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Bromonide 0.33% gel
Intense Pulsed Light (M22)
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea focused on measuring Rosacea, Bromonidine, intensed pulse light
Eligibility Criteria
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.
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment with bromonide 0.33% gel
Treatment with bromonide 0.33% gel & IPL
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03053700
First Posted
February 6, 2017
Last Updated
October 27, 2022
Sponsor
Rabin Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03053700
Brief Title
Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea
Official Title
Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea- a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Withdrawn
Why Stopped
During study new treatments were available, which may be more effective than proposed study treatment.
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
January 2, 2019 (Actual)
Study Completion Date
January 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
Rosacea, Bromonidine, intensed pulse light
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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
Outcomes Assessor
Masking Description
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.
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with bromonide 0.33% gel
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Treatment with bromonide 0.33% gel & IPL
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bromonide 0.33% gel
Intervention Description
Patients would be treated with full face application of bromonide 0.33% gel once daily for three months.
Intervention Type
Device
Intervention Name(s)
Intense Pulsed Light (M22)
Intervention Description
Half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.
Primary Outcome Measure Information:
Title
patient self-assessment questionaires score change
Description
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
Title
Physicians' unblinded score assessment
Description
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
Title
Physicians' unblinded score assessment
Description
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
Title
patient self-assessment questionaires score change
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assi Levi, Dr.
Organizational Affiliation
Rabin Medical center, Petach Tikva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petaẖ Tiqwa
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea
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