Clinical trial NCT03418610: Azelaic Acid Foam 15% in the Treatment of Papulopustular Rosacea
Official title: Azelaic Acid Foam 15% in the Treatment of Papulopustula Rosacea: An Evaluation of Photographic Evidence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea, Papulopustular
Keywords: Rosacea
Lead sponsor: Clinical Research Center of the Carolinas
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2018-02-01
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Site, Single Arm Open Label Study
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

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Primary outcomes:
measure: Inflammatory Lesion Count
timeFrame: 12 weeks
Secondary outcomes:
measure: Investigator Global Assessment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Clinical Research Center of the Carolinas
state: South Carolina
Study officials:
affiliation: Medical Director
name: Todd Schlesinger, MD, FAAD
role: PRINCIPAL_INVESTIGATOR
References: