Combination Gel and Vascular ND in Mild to Moderate Rosacea

This study has been completed.
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Amy McMichael, Wake Forest School of Medicine
ClinicalTrials.gov Identifier:
NCT01631656
First received: June 27, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Rosacea
Drug: Azelaic acid
Device: Nd:Yag laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combination Finacea Gel and Vascular Nd:Yag Laser Therapy for Mild to Moderate Rosacea

Resource links provided by NLM:


Further study details as provided by Wake Forest School of Medicine:

Primary Outcome Measures:
  • IGA of Improvement [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Investigator Global Assessment of Improvement measuring reduction in rosacea severity from Screening/Baseline to Week 6.


Enrollment: 10
Study Start Date: July 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azelaic Acid plus Laser
Azelaic acid 15% twice daily for 6 weeks, plus laser treatment with Nd:Yag laser once at 2 weeks.
Drug: Azelaic acid
15% gel, twice daily, 6 weeks
Other Name: Finacea gel
Device: Nd:Yag laser
Treatment with Nd:Yag laser of half the face, once at Week 2.
Active Comparator: Azelaic acid only
Treatment with azelaic acid 15% twice daily for 6 weeks with no laser treatment.
Drug: Azelaic acid
15% gel, twice daily, 6 weeks
Other Name: Finacea gel

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631656

Locations
United States, North Carolina
Wake Forest University Health Sciences Dept of Dermatology
Winston Salem, North Carolina, United States, 27104
Sponsors and Collaborators
Wake Forest School of Medicine
Bayer
Investigators
Principal Investigator: Amy McMichael, MD Wake Forest School of Medicine
  More Information

No publications provided

Responsible Party: Amy McMichael, Professor of Dermatology, Wake Forest School of Medicine
ClinicalTrials.gov Identifier: NCT01631656     History of Changes
Other Study ID Numbers: II-AM-Intendis-ROS
Study First Received: June 27, 2012
Last Updated: May 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest School of Medicine:
Rosacea, Mild, Moderate, Combination Therapy, Laser, Finacea Gel, Azelaic Acid,

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 23, 2014