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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier:
NCT00892281
First received: April 30, 2009
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Rosacea
Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy
Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma Laboratories, L.P.:

Primary Outcome Measures:
  • Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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:
  • Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint [ Time Frame: Baaseline to Week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1421
Study Start Date: April 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Oracea® as monotherapy
Oracea as monotherapy
Drug: doxycycline (Oracea®) 40 mg modified release as monotherapy
Take once daily in the morning
Other Name: Oracea®
Oracea® as add-on therapy
Oracea® as add-on Therapy (Oracea® + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides
Drug: doxycycline (Oracea®) 40 mg modified release as add-on therapy
Take once daily in the morning
Other Name: Oracea®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892281

Locations
United States, Kentucky
REGISTRAT® - MAP1, Inc. (CRO)
Lexington, Kentucky, United States, 40504-3276
Sponsors and Collaborators
Galderma Laboratories, L.P.
Investigators
Study Director: Ronald W Gottschalk, MD Galderma Laboratories, L.P.
  More Information

No publications provided

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00892281     History of Changes
Other Study ID Numbers: US10120
Study First Received: April 30, 2009
Results First Received: October 26, 2010
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on August 21, 2014