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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Rabin Medical Center

Current Primary Outcome:

  • 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.
  • 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.
  • 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.
  • 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.


Original Primary Outcome:

  • 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.
  • Physicians' unblinded score assessment [ 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.
  • Physicians' unblinded score assessment [ Time Frame: six months after initiation of treatment compared to Baseline ]
  • Physicians' unblinded score assessment [ Time Frame: three months after initiation of treatment compared to Baseline ]


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Rabin Medical Center

Dates:
Date Received: February 6, 2017
Date Started: March 2017
Date Completion: January 2018
Last Updated: February 23, 2017
Last Verified: January 2017