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

Papulopustular Rosacea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01872715
• Other study ID #: GLI.04.SPR.US10233
• Status: Completed
• Phase: Phase 4
• Start date: March 2013
• Est. completion date: June 2013

Study information

• Verified date: January 2016
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Papulopustular Rosacea
• Rosacea

Intervention

Drug:
• Oracea

Locations

Country	Name	City	State
United States	Stephens & Associates Dallas Research Center	Carrollton	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rosacea Score on the Visual Analog Scale	VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable	Baseline, Weeks 2, 6, and 12
Secondary	Rosacea-Specific Quality of Life Index	ROSACEA-SPECIFIC QUALITY OF LIFE INDEX©: average of scores to 22 questions on a 5 point scale (1 = never, 5 = all the time)	Baseline, Weeks 2, 6, and 12
Secondary	Patient Global Assessment (PGA) of Rosacea Scores	Patient Global Assessment (PGA) of Rosacea: 0 = clear, no signs or symptoms present; 1 = Near clear, 1 or 2 papules; 2 = mild, some (3 to 10) papules/pustules; 3 = moderate, moderate (11 to 19) number of papules and pustules; 4 = severe, numerous (= 20) papules/pustules; nodules	Baseline, Weeks 2, 6, and 12
Secondary	Patient Satisfaction Question	The patient satisfaction question was answered by the subject at week 2, week 6, and week 12. The subject was asked how satisfied they were with this treatment (doxycycline MR) for rosacea.	Week 2, 6, and 12