Intendis, the makers of Finacea are to trial the combination of ND:Yag laser treatment with and without the addition of Finacea during treatment. As the study will be a spilt face trial, researchers will be able to show that the addition of Finacea does, or does not make a difference to the outcome of the laser treatment.
The study wills assess acneiform lesions, redness, and telangiectasias.
The recent update to Trial NCT01631656 shows that the trial has recently completed the involvement of 10 – 15 participants.
Combination Gel and Vascular ND in Mild to Moderate Rosacea
Sponsor: Wake Forest University
Collaborator: Intendis GmbH
Information provided by (Responsible Party): Amy McMichael, Wake Forest University
ClinicalTrials.gov Identifier: NCT01631656
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.
Arm 1: Azelaic acid 15% twice daily for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks. (Nd:Yag laser of half the face, once at Week 2.)
Arm 2: Treatment with azelaic acid 15% twice daily for 6 weeks with no laser treatment
Detailed Description:
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.
