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

Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03053700
• Other study ID #: 0682-16RMC
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 1, 2018
• Est. completion date: January 2, 2019

Study information

• Verified date: September 2018
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2, 2019
• Est. primary completion date: January 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rosacea

Intervention

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.

Locations

Country	Name	City	State
Israel	Rabin Medical Center	Peta? Tiqwa

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	three months after initiation of treatment compared to Baseline
Primary	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.	three months after initiation of treatment compared to Baseline
Primary	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.	six months after initiation of treatment compared to Baseline
Primary	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.	six months after initiation of treatment compared to Baseline