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

NCT ID: NCT00892281

Last Updated: 2022-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1421 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2009-10-31

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.

Conditions

Rosacea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oracea® as monotherapy

Oracea as monotherapy

Group Type: OTHER

doxycycline (Oracea®) 40 mg modified release as monotherapy

Intervention Type: DRUG

Take once daily in the morning

Oracea® as add-on therapy

Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides

Group Type: OTHER

doxycycline (Oracea®) 40 mg modified release as add-on therapy

Intervention Type: DRUG

Take once daily in the morning

Interventions

doxycycline (Oracea®) 40 mg modified release as monotherapy

Take once daily in the morning

Intervention Type: DRUG

doxycycline (Oracea®) 40 mg modified release as add-on therapy

Take once daily in the morning

Intervention Type: DRUG

Other Intervention Names

Oracea®; Oracea®

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald W Gottschalk, MD

Role: STUDY_DIRECTOR

Galderma R&D

Locations

REGISTRAT® - MAP1, Inc. (CRO)

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

US10120

Identifier Type: -

Identifier Source: org_study_id