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

Rosacea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00892281
• Other study ID #: US10120
• Status: Completed
• Phase: Phase 4
• Start date: April 2009
• Est. completion date: October 2009

Study information

• Verified date: September 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1421
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rosacea

Intervention

Drug:
• doxycycline (Oracea®) 40 mg modified release as monotherapy
Take once daily in the morning
• doxycycline (Oracea®) 40 mg modified release as add-on therapy
Take once daily in the morning

Locations

Country	Name	City	State
United States	REGISTRAT® - MAP1, Inc. (CRO)	Lexington	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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