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

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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03053700
Enrollment
0
Registered
2017-02-15
Start date
2018-12-01
Completion date
2019-01-02
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea

Keywords

Rosacea, Bromonidine, intensed pulse light

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.

Interventions

DRUGBromonide 0.33% gel

Patients would be treated with full face application of bromonide 0.33% gel once daily for three months.

DEVICEIntense Pulsed Light (M22)

Half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.

Sponsors

Rabin Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
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.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
patient self-assessment questionaires score changethree months after initiation of treatment compared to BaselinePatient 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 assessmentthree months after initiation of treatment compared to BaselinePhysician 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.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026