Phase 4
N=1,421
ORCA - Oracea® for Rosacea: A Community-based Assessment
Rosacea
Bottom Line
View on ClinicalTrials.gov: NCT00892281 ↗Enrolled (actual)
1,421
Serious AEs
0.4%
Results posted
Nov 2010
Primary outcome: Primary: Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- doxycycline (Oracea®) 40 mg modified release as monotherapy (Drug); doxycycline (Oracea®) 40 mg modified release as add-on therapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear) |
616; 106 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00892281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.