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

Phase 4

Completed

• Conditions: Rosacea
• Interventions: Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy; Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy

• Registration Number: NCT00892281
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-30
• Study First Submitted QC: 2009-05-01
• Study First Posted: 2009-05-04
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2010-10-26
• Results First Submitted QC: 2010-10-26
• Results First Posted: 2010-11-18
• Status Verified: 2012-09
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1421

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oracea® as monotherapy	doxycycline (Oracea®) 40 mg modified release as monotherapy	Oracea as monotherapy
Oracea® as add-on therapy	doxycycline (Oracea®) 40 mg modified release as add-on therapy	Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides

Primary Outcome Measures

Name	Time	Method
Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint	Baseline to Week 12	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

Name	Time	Method
Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint	Baaseline to Week 12	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)	Baseline to Week 12	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.

Trial Locations

Locations (1)

REGISTRAT® - MAP1, Inc. (CRO); 🇺🇸 Lexington, Kentucky, United States