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

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03053700
Collaborator
(none)
12
Enrollment
2
Arms
10.1
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Bromonide 0.33% gel
  • Device: Intense Pulsed Light (M22)
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention 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.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 (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.
Primary Purpose:
Treatment
Official Title:
Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea- a Prospective Study
Anticipated Study Start Date :
Mar 1, 2017
Anticipated Primary Completion Date :
Jan 1, 2018
Anticipated Study Completion Date :
Jan 1, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. patient self-assessment questionaires score change [three 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.

  2. Physicians' unblinded score assessment [three 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.

  3. 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.

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Rabin Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Rabin Medical Center
ClinicalTrials.gov Identifier:
NCT03053700
Other Study ID Numbers:
  • 0682-16RMC
First Posted:
Feb 15, 2017
Last Update Posted:
Feb 27, 2017
Last Verified:
Jan 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Rabin Medical Center
Rosacea, Bromonidine, intensed pulse light
Additional relevant MeSH terms:
Rosacea

Study Results

No Results Posted as of Feb 27, 2017