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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2009

Interventions

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

Arms, Groups and Cohorts

  • Other: Oracea® as monotherapy
    • Oracea as monotherapy
  • Other: Oracea® as add-on therapy
    • Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides

Clinical Trial Outcome Measures

Primary Measures

  • Change in Investigator’s Global Assessment (IGA) Score From Baseline to Endpoint
    • Time Frame: 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 Measures

  • Change in Clinician’s Erythema Assessment Scale (CEA) Score From Baseline to Endpoint
    • Time Frame: 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)
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Galderma Laboratories, L.P.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ronald W Gottschalk, MD, Study Director, Galderma Laboratories, L.P.

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