Combination Gel and Vascular ND in Mild to Moderate Rosacea

NCT01631656 | Completed Results FDA Drug FDA Device

• 1 other identifier: IRB00012702
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rosacea

Keywords

Rosacea, Laser, Finacea Gel, Azelaic Acid,

Outcome Measures

Primary Outcomes (1)

• IGA of Improvement

  Investigator's Global Assessment of severity integrates all lesions for overall score. This measure is commonly used as a quick and simple way to quantify disease severity both for clinical studies and in a non-study clinic setting. Score ranges from 0 = Clear or "No inflammatory signs of rosacea" to 6 = "Severe inflammatory signs of rosacea."

  6 weeks

Study Arms (2)

Azelaic Acid plus Laser

EXPERIMENTAL

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

Drug: Azelaic acid; Device: Nd:Yag laser

Laser only

ACTIVE COMPARATOR

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

Device: Nd:Yag laser

Interventions

Azelaic acid DRUG

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

Also known as: Finacea gel

Azelaic Acid plus Laser

Nd:Yag laser DEVICE

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

Azelaic Acid plus Laser; Laser only

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Bayer: collaborator

Study Sites (1)

Wake Forest University Health Sciences Dept of Dermatology

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr Amy McMichael
• Organization: WakeForest University Health Sciences

amcmicha@wakehealth.edu

336-716-3775

Study Officials

• Amy McMichael, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2012
• First Posted: June 29, 2012
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: September 12, 2018
• Results First Posted: November 28, 2017

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)