Back to resultsORCA - Oracea® for Rosacea: A Community-based Assessment
Primary Purpose
Rosacea
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
doxycycline (Oracea®) 40 mg modified release as monotherapy
doxycycline (Oracea®) 40 mg modified release as add-on therapy
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea
Eligibility Criteria
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
Sites / Locations
- REGISTRAT® - MAP1, Inc. (CRO)
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Oracea® as monotherapy
Oracea® as add-on therapy
Arm Description
Oracea as monotherapy
Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00892281
Brief Title
ORCA - Oracea® for Rosacea: A Community-based Assessment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1421 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oracea® as monotherapy
Arm Type
Other
Arm Description
Oracea as monotherapy
Arm Title
Oracea® as add-on therapy
Arm Type
Other
Arm Description
Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides
Intervention Type
Drug
Intervention Name(s)
doxycycline (Oracea®) 40 mg modified release as monotherapy
Other Intervention Name(s)
Oracea®
Intervention Description
Take once daily in the morning
Intervention Type
Drug
Intervention Name(s)
doxycycline (Oracea®) 40 mg modified release as add-on therapy
Other Intervention Name(s)
Oracea®
Intervention Description
Take once daily in the morning
Primary Outcome Measure Information:
Title
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint
Description
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.
Time Frame
Baaseline to Week 12
Title
Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)
Description
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.
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald W Gottschalk, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
REGISTRAT® - MAP1, Inc. (CRO)
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504-3276
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ORCA - Oracea® for Rosacea: A Community-based Assessment
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