Combination Gel and Vascular ND in Mild to Moderate Rosacea

NCT ID: NCT01631656

Last Updated: 2018-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2011-02-28

Brief 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.

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.

Conditions

Rosacea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Azelaic Acid plus Laser

Azelaic acid 15% twice daily on half the face for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks.

Group Type: EXPERIMENTAL

Azelaic acid

Intervention Type: DRUG

15% gel on half the face, twice daily, 6 weeks

Nd:Yag laser

Intervention Type: DEVICE

Treatment with Nd:Yag laser , once at Week 2.

Laser only

laser treatment on all face once at 2 weeks with no azelaic acid on one side of the face

Group Type: ACTIVE_COMPARATOR

Nd:Yag laser

Intervention Type: DEVICE

Treatment with Nd:Yag laser , once at Week 2.

Interventions

Azelaic acid

15% gel on half the face, twice daily, 6 weeks

Intervention Type: DRUG

Nd:Yag laser

Treatment with Nd:Yag laser , once at Week 2.

Intervention Type: DEVICE

Other Intervention Names

Finacea gel

Eligibility Criteria

Inclusion Criteria

• Male or female subject with mild to moderate rosacea, age 18 and over, who agrees to participate and provide written consent.
• Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment (Appendix B) and at least a "Mild" rating on the Telangiectasia Rating Scale
• Subjects must be eligible to undergo vascular laser therapy and have been previously approved for therapy.

Exclusion Criteria

• Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.
• Use of topical therapy for rosacea within 2 weeks of baseline.
• Use of systemic corticosteroids within 4 weeks of baseline.
• Use of systemic retinoids within 6 months of baseline
• Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
• Amount of disease involvement that would require >60 gm of cream in a 6 week period.
• Subjects with known allergy or sensitivity to azelaic acid (Finacea®) gel or components therein, such as propylene glycol.
• Contraindication to vascular laser therapy, such as infections.
• Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Reliable methods of birth control are: abstinence (not having sex), oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation, or vasectomy of the partner (with confirmed negative sperm counts) in a monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or a cervical cap or sponge. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy McMichael, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Wake Forest University Health Sciences Dept of Dermatology

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

IRB00012702

Identifier Type: -

Identifier Source: org_study_id