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

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ClinicalTrials.gov Identifier: NCT00892281
Recruitment Status : Completed
First Posted : May 4, 2009
Results First Posted : November 18, 2010
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
Galderma Laboratories, L.P.

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.

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 1421 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2009
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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®



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Galderma Laboratories, L.P.
ClinicalTrials.gov Identifier: NCT00892281     History of Changes
Other Study ID Numbers: US10120
First Posted: May 4, 2009    Key Record Dates
Results First Posted: November 18, 2010
Last Update Posted: October 2, 2012
Last Verified: September 2012

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