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

NCT ID: NCT01872715

Last Updated: 2022-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-06-30

Brief Summary

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

Conditions

Papulopustular Rosacea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oracea

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

Group Type: EXPERIMENTAL

Oracea

Intervention Type: DRUG

Interventions

Oracea

Intervention Type: DRUG

Other Intervention Names

doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads)

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stephens & Associates Dallas Research Center

Carrollton, Texas, United States

Countries

United States

Other Identifiers

GLI.04.SPR.US10233

Identifier Type: -

Identifier Source: org_study_id