Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea

NCT03418610 | Completed Phase 4 FDA Drug

• 1 other identifier: Bayer Rosacea
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being performed to evaluate the photographic evidence of the efficacy and tolerability of Azelaic Acid Foam 15% in the treatment of papulopustular rosacea.

Conditions

Rosacea, Papulopustular

Keywords

Rosacea

Outcome Measures

Primary Outcomes (1)

• Inflammatory Lesion Count

  The change in inflammatory lesion counts at week 12 compared to baseline

  12 weeks

Secondary Outcomes (1)

• Investigator Global Assessment

  12 weeks

Study Arms (1)

Open Label Single Arm

OTHER

Azelaic Acid Foam 15% applied twice daily

Drug: Azelaic Acid foam 15%

Interventions

Azelaic Acid foam 15% DRUG

mild to moderate rosacea

Also known as: Finacea

Open Label Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects age 18 or older.
• Diagnosis of moderate to severe papulopustular rosacea with IGA of 3- moderate or 4-severe.
• Presence of 12 - 50 inflammatory lesions and persistent erythema with or without telangiectasia.
• Subjects must read, understand, and sign the Informed Consent.
• Subjects must be willing and able to comply with study procedures and visit schedule requirements.
• Women of childbearing potential that are willing to use an acceptable method of contraception during the study.

You may not qualify if:

• Active or localized or systemic infections.
• Subjects must not be immunocompromised.
• Known unresponsiveness or allergy to azelaic acid.
• Subjects unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of the clinical study, uncooperative attitude or unlikelihood of completing the study (e.g. drug or alcohol abuse).
• Subjects must not be pregnant or breastfeeding.
• Presence of dermatoses that might interfere with the ability to diagnose and/or evaluate rosacea.
• Presence of other types of rosacea.
• Laser surgery on the face for the treatment of telangiectasia or other conditions within 6 weeks of study enrollment.
• Use of medications or products for the treatment of rosacea or other medical conditions within the following time periods prior to study enrollment. Use of these medications will be prohibited during the trial.
• Topical Prescription or Nonprescription medications 6 weeks Oral retinoids 6 months Tetracycline (ex. doxycycline, minocycline 2 months Corticosteroids 4 weeks Erythromycin or azithromycin 4 weeks Other systemic medications to treat rosacea 6 weeks
• Refusal to sign the Informed Consent document or Photo Release document and/or refusal to comply with all follow-up requirements.
• Use of medications that are known to cause flushing.
• Dose changes in the last 90 days or initiation of beta-blockers, vasodilators, vasoconstrictors, nonsteroidal anti-inflammatory drugs, hormone therapy, and/or other drugs known to cause acneform eruptions.

Sponsors & Collaborators

• Clinical Research Center of the Carolinas: lead
• Bayer: collaborator

Study Sites (1)

Clinical Research Center of the Carolinas

Charleston, South Carolina, 29407, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

azelaic acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Todd Schlesinger, MD, FAAD

  Medical Director

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Site, Single Arm Open Label Study

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: February 1, 2018
• Study Start: December 6, 2017
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: July 24, 2019

Record last verified: 2018-01

Locations

US (1)