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Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea

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ClinicalTrials.gov Identifier: NCT03418610
Recruitment Status : Recruiting
First Posted : February 1, 2018
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Clinical Research Center of the Carolinas

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.

Condition or disease Intervention/treatment Phase
Rosacea, Papulopustular Drug: Azelaic Acid foam 15% Phase 4

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  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single Site, Single Arm Open Label Study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Azelaic Acid Foam 15% in the Treatment of Papulopustula Rosacea: An Evaluation of Photographic Evidence
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rosacea

Arm Intervention/treatment
Open Label Single Arm
Azelaic Acid Foam 15% applied twice daily
Drug: Azelaic Acid foam 15%
mild to moderate rosacea
Other Name: Finacea




Primary Outcome Measures :
  1. Inflammatory Lesion Count [ Time Frame: 12 weeks ]
    The change in inflammatory lesion counts at week 12 compared to baseline


Secondary Outcome Measures :
  1. Investigator Global Assessment [ Time Frame: 12 weeks ]
    Severity of Disease by Investigator Global Assessment, Score of 0 (Clear) - 4(Severe)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03418610


Contacts
Contact: Linda Wozniak 843-556-8886 Linda@dermandlaser.com

Locations
United States, South Carolina
Clinical Research Center of the Carolinas Recruiting
Charleston, South Carolina, United States, 29407
Contact: Linda Wozniak    843-556-8886    Linda@dermandlaser.com   
Principal Investigator: Todd E Schlesinger, MD         
Sponsors and Collaborators
Clinical Research Center of the Carolinas
Bayer
Investigators
Principal Investigator: Todd Schlesinger, MD, FAAD Medical Director

Responsible Party: Clinical Research Center of the Carolinas
ClinicalTrials.gov Identifier: NCT03418610     History of Changes
Other Study ID Numbers: Bayer Rosacea
First Posted: February 1, 2018    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Clinical Research Center of the Carolinas:
Rosacea

Additional relevant MeSH terms:
Rosacea
Skin Diseases
Azelaic acid
Antineoplastic Agents
Dermatologic Agents