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Completed

NCT Number: NCT00892281

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

REGISTRAT® - MAP1, Inc. (CRO)

Lexington, Kentucky, 40504-3276, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

doxycycline (Oracea®) 40 mg modified release as monotherapy

Drug

Take once daily in the morning

Other names: Oracea®

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

Drug

Take once daily in the morning

Other names: Oracea®

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 4, 2009
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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