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

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ClinicalTrials.gov Identifier: NCT03053700
Recruitment Status : Unknown
Verified January 2017 by Rabin Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 15, 2017
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Rosacea 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
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
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

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.




Primary Outcome Measures :
  1. patient self-assessment questionaires score change [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03053700


Contacts
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Contact: Assi Levi, Dr. 972-3-9376658 assile@clalit.org.il
Contact: Shira Waks, Mrs. 972-3-9377435 shiraw@clalit.org.il

Sponsors and Collaborators
Rabin Medical Center
Investigators
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Principal Investigator: Assi Levi, Dr. Rabin Medical center, Petach Tikva

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Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT03053700     History of Changes
Other Study ID Numbers: 0682-16RMC
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Rosacea
Skin Diseases