Clinical Trial: Combination Gel and Vascular ND in Mild to Moderate Rosacea

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Combination Finacea Gel and Vascular Nd:Yag Laser Therapy for Mild to Moderate Rosacea

Brief Summary:

The purpose of this study is to compare efficacy and outcomes of treatment with azelaic acid (Finacea Gel) and Vascular ND:Yag laser therapy versus Vascular ND:Yag laser therapy alone via a split face study design in approximately ten to fifteen subjects with mild to moderate rosacea.

We hypothesize that treatment of rosacea with combination azelaic acid (Finacea Gel) and Vascular ND:Yag laser therapy will lead to a greater improvement in lesion count, redness and telangiectasias compared to treatment with Vascular ND: Yag laser therapy alone.


Detailed Summary: This is a single center, open-label, split-face, prospective study of ten to fifteen subjects seeking vascular laser therapy for the treatment of mild to moderate rosacea. Subjects will be screened for eligibility for vascular laser therapy outside of the confines of this protocol. Once approved for laser, subjects will be screened for study enrollment and topical treatment of their rosacea at the Screening/Baseline visit. All subjects will receive Finacea 15% gel and will be instructed to apply the study drug to one half of the face, twice daily. Drug application will be modified just prior to and after the subjects' laser treatment to reduce irritation. Subjects will undergo Vascular Nd:Yag laser therapy to involved areas over the whole face two weeks after initiating Finacea treatment. Subjects will continue to use Finacea gel to one half of the face for the duration of the study. Assessment of acneiform lesions, redness, and telangiectasias will be performed at Screening/Baseline, Week 2 (prior to laser treatment), and week 6/End of Study. Photography will be performed at Screening/Baseline and End of Study visits. Adverse events will be assessed at each visit, and a patient survey will be completed at Baseline and at Week 6/End of Study visits.
Sponsor: Wake Forest University Health Sciences

Current Primary Outcome: IGA of Improvement [ Time Frame: 6 weeks ]

Investigator Global Assessment of Improvement measuring reduction in rosacea severity from Screening/Baseline to Week 6.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Wake Forest University Health Sciences

Dates:
Date Received: June 27, 2012
Date Started: July 2010
Date Completion:
Last Updated: May 5, 2016
Last Verified: May 2016