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

Galderma R&D1,421 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,421

Conditions

Rosacea

Interventions

doxycycline (Oracea®) 40 mg modified release as monotherapyDRUG

Take once daily in the morning

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

Take once daily in the morning

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

REGISTRAT® - MAP1, Inc. (CRO)

Lexington, Kentucky, United States

Outcomes

Primary Outcomes

Change in Investigator's Global Assessment (IGA) Score From Baseline to Endpoint

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.

Time frame: Baseline to Week 12

Secondary Outcomes

Change in Clinician's Erythema Assessment Scale (CEA) Score From Baseline to Endpoint

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.

Time frame: Baaseline to Week 12

Number of Treatment Responders at Endpoint, Where Response is Defined as an IGA Score of 0 (Clear) or 1 (Near Clear)

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.

Time frame: Baseline to Week 12

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.