Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea

Azelaic Acid Foam 15% in the Treatment of Papulopustula Rosacea: An Evaluation of Photographic Evidence

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.

Study Overview

• Status: Completed
• Conditions: Rosacea, Papulopustular
• Intervention / Treatment: Drug: Azelaic Acid foam 15%

Detailed Description

This is a single site, single arm open label study of Azelaic Acid foam 15% for the treatment of moderate to severe papulopustular rosacea. All patients will apply Azelaic Acid foam twice daily. At scheduled visits, high resolution equipment will be used to measure 3D topographical values for elevation of papules and pustules to objectively evaluate reduction of papulopustular lesions. Investigator and subject assessments will also be completed to assess the level of rosacea at weeks 4,8 and 12.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Clinical Research Center of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Active or localized or systemic infections.
2. Subjects must not be immunocompromised.
3. Known unresponsiveness or allergy to azelaic acid.
4. 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).
5. Subjects must not be pregnant or breastfeeding.
6. Presence of dermatoses that might interfere with the ability to diagnose and/or evaluate rosacea.
7. Presence of other types of rosacea.
8. Laser surgery on the face for the treatment of telangiectasia or other conditions within 6 weeks of study enrollment.

9. 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

10. Refusal to sign the Informed Consent document or Photo Release document and/or refusal to comply with all follow-up requirements.
11. Use of medications that are known to cause flushing.

12. 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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Open Label Single Arm; Azelaic Acid Foam 15% applied twice daily	Drug: Azelaic Acid foam 15%; mild to moderate rosacea; Other Names: Finacea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Lesion Count	The change in inflammatory lesion counts at week 12 compared to baseline	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Assessment	Severity of Disease by Investigator Global Assessment, Score of 0 (Clear) - 4(Severe)	12 weeks

Collaborators and Investigators

• Sponsor: Clinical Research Center of the Carolinas
• Collaborators: Bayer
• Investigators: Principal Investigator: Todd Schlesinger, MD, FAAD, Medical Director

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 6, 2017
• Primary Completion (ACTUAL): January 9, 2019
• Study Completion (ACTUAL): January 9, 2019

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (ACTUAL): February 1, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Rosacea
• Additional Relevant MeSH Terms: Skin Diseases; Rosacea; Antineoplastic Agents; Dermatologic Agents; Azelaic acid
• Other Study ID Numbers: Bayer Rosacea

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes