Status and phase
Conditions
Treatments
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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.
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal