Preferences & Treatment Satisfaction Drivers in Rosacea Patients

Browse trials for

• Rosacea 231

Rosacea

231 studies on the registry are indexed under Rosacea; 20 are open to participants now.

This study's enrollment of 206 is below the median of 240 across 22 observational studies indexed under Rosacea.

Lead sponsor

LEO Pharma is the lead sponsor of 225 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Study population

Groups and cohorts

• Rosacea treated patients

  Patients using topical rosacea treatment

  Drug: Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251) · Drug: Azelaic Acid Cream · Drug: Metronidazole gel · Drug: Metronidazole cream · Drug: Metronidazole Emulsion · Drug: Metronidazole Lotion · Drug: Brimonidine Tartrate Gel

Interventions

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

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

• DrugAzelaic Acid Cream

  Azelaic Acid Cream 20%

• DrugMetronidazole gel

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

• DrugMetronidazole cream

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

• DrugMetronidazole Emulsion

  Metronidazole Emulsion 0.75%

• DrugMetronidazole Lotion

  Metronidazole Lotion 0,75%

• DrugBrimonidine Tartrate Gel

  Brimonidine Tartrate Gel 0.33%

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

   Time frame: Rosacea treatment in the past 4 weeks

Secondary outcomes

1. Self-reported likelihood of switching to a topical rosacea treatments

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

   Time frame: Rosacea treatment in the past 4 weeks

2. Quality of life

   Measured using Dermatology Life Quality Index (DLQI): The DLQI consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, and school, personal relationships and treatment

   Time frame: Rosacea treatment in the past 4 weeks

3. Treatment satisfaction

   Assessed by a score on the Treatment Satisfaction with Medicines Questionnaire (SATMED-Q). Scores will be standardized and expressed as a 0-100 standardized score

   Time frame: Rosacea treatment in the past 4 weeks

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

   Extracted from the Rosacea Treatment Preference Questionnaire

   Time frame: Rosacea treatment in the past 4 weeks

Other outcomes

1. Baseline demographics and clinical characteristics: Age

   Assessed from retrospective analysis of electronic medical records

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

2. Baseline demographics and clinical characteristics: Gender

   Assessed from retrospective analysis of electronic medical records

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

3. Baseline demographics and clinical characteristics: Insurance type

   Assessed from retrospective analysis of electronic medical records

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

4. Baseline demographics and clinical characteristics: Charlson Comorbidity Index (CCI)

   Assessed from retrospective analysis of electronic medical records

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

5. Baseline demographics and clinical characteristics: Rosacea-relevant comorbidities and complications

   Assessed from retrospective analysis of electronic medical records: Blepharitis (ICD-9: 373.0) Conjunctivitis (ICD-9: 372.0-372.2) Corneal neovascularization / keratitis (ICD-9: 370) Depression (ICD-9: 296.2-296.3) Migraine (ICD-9: 346)

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

6. Baseline demographics and clinical characteristics: Rosacea treatment-related adverse events

   Assessed from retrospective analysis of electronic medical records: Burning/stinging/tingling (ICD-9: 782.0) Pruritus (ICD-9: 698) Scaling/dry skin/xerosis (ICD-9: 692.9, 706.8) Erythema/irritation (ICD-9: 695) Contact dermatitis (ICD-9: 692.3, 692.8, 692.9) Facial edema (ICD-9: 782.3) Acne (ICD-9: 706.1)

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

7. Current and past medication use

   Assessed from retrospective analysis of electronic medical records Including: azelaic acid gel, azelaic acid cream, metronidazole gel, metronidazole cream, metronidazole lotion, metronidazole emulsion, brimonidine tartrate gel

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

8. Self-reported adverse events associated with patients' satisfaction/dissatisfaction

   Assessed from the Rosacea Treatment Preference Questionnaire: Rated on a scale of 0 to 10, with 0 meaning no pain/discomfort and 10 meaning unbearable pain/discomfort

   Time frame: Rosacea treatment in the past 4 weeks