NCT02602470

Brief Summary

To survey patients with rosacea about their rosacea treatment preferences as well as to assess potential drivers of rosacea treatment satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2016

Completed
Last Updated

April 1, 2020

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

November 10, 2015

Last Update Submit

March 30, 2020

Conditions

Rosacea

Outcome Measures

Primary Outcomes (1)

  • Self-reported concerns and importance of such concerns regarding their current topical rosacea treatments

    Assessed from the Rosacea Treatment Preference Questionnaire: Rated on a scale of 0 to 10, with 0 meaning not at all important and 10 meaning extremely important

    Rosacea treatment in the past 4 weeks

Secondary Outcomes (4)

  • Self-reported likelihood of switching to a topical rosacea treatments

    Rosacea treatment in the past 4 weeks

  • Quality of life

    Rosacea treatment in the past 4 weeks

  • Treatment satisfaction

    Rosacea treatment in the past 4 weeks

  • Self-reported concerns and importance (a rating scale) of such concerns that patients would consider when switching to a new topical rosacea treatment

    Rosacea treatment in the past 4 weeks

Other Outcomes (8)

  • Baseline demographics and clinical characteristics: Age

    Retrospective database analysis: encompassing patient data from up to 5 years

  • Baseline demographics and clinical characteristics: Gender

    Retrospective database analysis: encompassing patient data from up to 5 years

  • Baseline demographics and clinical characteristics: Insurance type

    Retrospective database analysis: encompassing patient data from up to 5 years

  • +5 more other outcomes

Study Arms (1)

Rosacea treated patients

Patients using topical rosacea treatment

Drug: Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)Drug: Azelaic Acid CreamDrug: Metronidazole gelDrug: Metronidazole creamDrug: Metronidazole EmulsionDrug: Metronidazole LotionDrug: Brimonidine Tartrate Gel

Interventions

Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)DRUG

Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser \& Moisturizing

Rosacea treated patients
Azelaic Acid CreamDRUG

Azelaic Acid Cream 20%

Rosacea treated patients
Metronidazole gelDRUG

Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser

Rosacea treated patients
Metronidazole creamDRUG

Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser

Rosacea treated patients
Metronidazole EmulsionDRUG

Metronidazole Emulsion 0.75%

Rosacea treated patients
Metronidazole LotionDRUG

Metronidazole Lotion 0,75%

Rosacea treated patients
Brimonidine Tartrate GelDRUG

Brimonidine Tartrate Gel 0.33%

Rosacea treated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who are using topical rosacea treatment

You may qualify if:

  • Male or female patients of at least 18 years of age at index date
  • At least one prescription for a topical rosacea treatments: Azelaic Acid Gel, Azelaic Acid Cream, Metronidazole Gel, Metronidazole Cream, Metronidazole Emulsion, Metronidazole Lotion, Brimonidine Tartrate Gel
  • At least one medical record with a diagnosis code for rosacea (ICD-9: 695.3)
  • At least 6 months of data history prior to the index date
  • Had at least one encounter at the Reliant Medical Group within 3 months prior to 01 January 2015

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Boston, Massachusetts, United States

Location

MeSH Terms

Conditions

Rosacea

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2015

First Posted

November 11, 2015

Study Start

January 8, 2015

Primary Completion

March 10, 2016

Study Completion

March 10, 2016

Last Updated

April 1, 2020

Record last verified: 2017-04

Locations

US(1)