Trial Condition(s):
Exploration of safety and efficacy of AzA 15% foam twice a day in rosacea
1402140
Not Available
Not Available
This exploratory study is being performed to determine whether a new form formulation of azelaic acid 15% is effective in the treatment of papulopustular rosecea.
- male and female patient at least 18 years of age - signed informed consent - Papulopustular rosacea with a minimum of 10 and a maximum of 50 papules and/or pustules, persistent erythema, and telangiectasia - Ability and willingness to accept and comply with treatment and required medical examinations
- Known non-responders to azelaic acid - Erythematotelangiectatic, rhinophymatous, ocular, or steroid rosacea - Presence of dermatoses that could interfere with the rosacea diagnosis - Treatment with isotretinoin in the six months prior to randomization - Treatment of the face with topical retinoids during the two weeks prior to randomization - Treatment with oral antibiotics during the four weeks prior to randomization - Treatment with topical antibiotics - Treatment with systemic corticosteroids during 4 weeks prior to randomization - Treatment of the face with topical corticosteroids during 2 weeks prior to randomization - Treatment of the face with topical imidazole antimycotics during 2 weeks prior to randomization - Treatment of the face with topical azelaic acid formulations during 2 weeks prior to randomization - Use of a sauna during 2 weeks prior to randomization and during the study - Facial laser surgery for telangiectasia during 6 weeks prior to randomization - Planned concurrent use of any treatment other than study medication that affects rosacea - History of hypersensitivity to propylene glycol or any other ingredient of the study drugs - Participation in another clinical trial during the last 4 weeks
Locations | |
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Locations Investigative Site Henderson, United States, 89052 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mason, United States, 45040 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cherry Creek Research, Inc Denver, United States, 80209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations VCR Office Norfolk, United States, 23507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Compliant Clinical Research Olathe, United States, 66062 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Academic Dermatology Albuquerque, United States, 87106 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Derm Research, Inc Austin, United States, 78759 | Contact Us: E-mail: [email protected] Phone: Not Available |
A 12-week exploratory, multicenter, double-blind, vehicle-controlled study to investigate the efficacy and safety of topical azelaic acid 15% foam twice daily in patients with papulopustular rosacea
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2