NCT03053700

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 6, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2019

Completed
Last Updated

October 31, 2022

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

February 6, 2017

Last Update Submit

October 27, 2022

Conditions

Rosacea

Keywords

Rosacea, Bromonidine, intensed pulse light

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Treatment with bromonide 0.33% gel

ACTIVE COMPARATOR

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

Treatment with bromonide 0.33% gel & IPL

ACTIVE COMPARATOR

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% gelDevice: Intense Pulsed Light (M22)

Interventions

Bromonide 0.33% gelDRUG

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

Treatment with bromonide 0.33% gelTreatment with bromonide 0.33% gel & IPL
Intense Pulsed Light (M22)DEVICE

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

Treatment with bromonide 0.33% gel & IPL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient (male or female) must be over 18 yaers old of age and fulfil one of the following:
  • Suffer from ETR
  • Suffer from PPR
  • Suffer from a combination of ETR and PPR.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

Location

MeSH Terms

Conditions

Rosacea

Interventions

Gels

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ColloidsComplex MixturesDosage FormsPharmaceutical Preparations

Study Officials

  • Assi Levi, Dr.

    Rabin Medical center, Petach Tikva

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 15, 2017

Study Start

December 1, 2018

Primary Completion

January 2, 2019

Study Completion

January 2, 2019

Last Updated

October 31, 2022

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)