Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea

Galderma

Status and phase: Completed; Phase 4

Conditions: Papulopustular Rosacea

Treatments: Drug: Oracea

Study type: Interventional

Funder types: Industry

Identifiers

NCT01872715

GLI.04.SPR.US10233

Details and patient eligibility

About

The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.

Enrollment: 24 patients

Sex: All

Ages: 25 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women
• 25-70 years
• Diagnosis of papulopustular rosacea
• Eligible for Oracea treatment

Exclusion criteria

• Allergies to components of investigational product and/or hypersensitivity to tetracyclines
• Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
• Used topical rosacea treatment within 30 days prior to baseline visit
• Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
• Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
• Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study
• Have planned surgical procedures during the course of the study
• Have used tetracycline antibiotics within 30 days prior to baseline visit or during study
• At risk in terms of precautions, warnings, and contraindications

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

Oracea

Experimental group

Description:

Oracea (doxycycline USP, 40mg\[30mg immediate release/ 10mg delayed release beads\] taken once daily in the morning on an empty stomach, one hour before meals or two hours after. Oral dose for 12 weeks

Treatment:

Drug: Oracea