ORCA - Oracea® for Rosacea: A Community-based Assessment

Study Overview
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Brief Summary
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The objective of this study is to assess the effectiveness, safety, subject satisfaction and quality of life with Oracea® when used as monotherapy or as add-on therapy to existing topical regimens for the treatment of rosacea.

Official Title
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A Phase 4, Open-Label, Multicenter, Community-based, 12-Week Trial Assessment of Effectiveness, Safety, and Subject Satisfaction With Oracea® [Doxycycline, USP] Capsules 40 mg (30 mg Immediate Release & 10 mg Delayed Release Beads) When Used as Monotherapy or as Add-On Therapy to Existing Topical Regimens for the Treatment of Rosacea

Conditions
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Rosacea

Intervention / Treatment
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* Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy
* Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged 18 and older Subjects with diagnosis of rosacea (IGA of 2 to 4) Exclusion Criteria: Subjects who used a topical or systemic acne treatment within 4 months of the baseline visit (retinoids and isotretinoin) Subjects who used a topical or systemic antibiotic within 4 weeks of the baseline visit Subjects who had laser or IPL (intense pulsed light) treatments within 3 months of the baseline visit and/or who plan to have these treatments during the study Subjects who have a known hypersensitivity to tetracyclines or ingredients of the add on medications Subjects who have stomach or GI problems, kidney disease or have an active systemic fungal infection or a vaginal yeast infection are excluded

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Oracea® as monotherapy<br>Oracea as monotherapy | Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy<br>* Take once daily in the morning<br>* Other names: Oracea®;|
| Other: Oracea® as add-on therapy<br>Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides | Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy<br>* Take once daily in the morning<br>* Other names: Oracea®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint | Number of participants with a change (Week 12 minus Baseline) in Investigator's Global Assessment (IGA) score. IGA is measured on a scale from 0 - 4 with 0 = Clear; 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12. | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint | Number of participants with a change (Week 12 minus Baseline) in Clinician's Erythema Assessment Scale (CEA) score. Clinician's Erythema Assessment Scale (CEA) is a scale from 0 - 4 with 0 = None; 1 = Mild; 2 = Moderate; 3 = Significant; and 4 = Severe. Results values (+4, +3, +2, +1, 0, -1, -2, -3, -4) represent change from Baseline to Week 12 in CEA. | Baaseline to Week 12 | 
| Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) | Number of treatment responders at week 12, where response is defined as an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (near clear). IGA is measured on a scale from 0 - 4 with 0 = Clear, 1 = Near Clear; 2 = Mild; 3 = Moderate; and 4 = Severe with 0 being best and 4 being worst. | Baseline to Week 12 |