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

NCT01872715 | Completed Phase 4 Results

• 1 other identifier: GLI.04.SPR.US10233
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

Papulopustular Rosacea; Oracea; anti inflammatory doxycycline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rosacea-Specific Quality of Life Index

  Baseline, Weeks 2, 6, and 12

• Patient Global Assessment (PGA) of Rosacea Scores

  Baseline, Weeks 2, 6, and 12

• Patient Satisfaction Question

  Week 2, 6, and 12

Study Arms (1)

Oracea

EXPERIMENTAL

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

Drug: Oracea

Interventions

Oracea DRUG

Also known as: doxycycline USP, 40 mg (30 mg immediate release/ 10 mg delayed release beads)

Oracea

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Stephens & Associates Dallas Research Center

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Doxycycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Results Point of Contact

• Title: Elizabeth M Nieman
• Organization: Galderma Laboratories, L.P.

elizabeth.nieman@galderma.com

817-961-5000

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2013
• First Posted: June 7, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 23, 2022
• Results First Posted: February 15, 2016

Record last verified: 2016-01

Locations

US (1)