Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild … (NCT00031096) | Clinical Trial Compass
CompletedPhase 3
Comparison of Efficacy and Safety of Azelaic Acid 15% Gel With Its Vehicle in Subjects With Mild to Moderate Acne
United States879 participantsStarted 2002-01
Plain-language summary
Comparison of efficacy and safety of Azelaic Acid 15% gel with its vehicle in male and female patients with mild to moderate acne.
Qualified subjects will apply the gel to their face twice a day for a period of 12 weeks. Subjects will be required to return to the doctor's office for up to 5 visits.
Who can participate
Age range12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
To be included in the study you MUST have:
* Predominantly facial localization of acne
* Mild to moderate acne vulgaris characterized by the presence of both inflammatory papules and/or pustules, and comedones (whiteheads/blackheads), and of a severity suitable for treatment with topical single therapy.
* a minimum of ten and a maximum of fifty inflammatory papules and/or pustules in the facial area and
* 10 to 100 comedones in the facial area
* no more than 3 small nodules (approx. 5 mm in diameter) in the facial area
* Male and female patients
* Age greater or equal to 12 years
* Ability and willingness to accept and comply with the administration of the investigational drugs over 12 weeks and to comply with the required medical examinations (signed informed consent).
Exclusion Criteria:
To be included in the study you MUST NOT have:
* Localization of acne predominantly on the chest and/or the back or confined to the chest and/or the back
* Sandpaper acne with hundreds of small facial comedones
* Moderate or severe acne requiring systemic therapy
* Multitude of small nodules and/or multiple large nodules, cysts, polyporous comedones, draining sinuses e.g. nodulocystic/conglobate acne
* Other skin conditions that might interfere with acne diagnosis and/or evaluation (such as facial psoriasis, seborrheic dermatitis, perioral dermatitis and papulopustular rosacea)
* Anticipated or scheduled hospitalization, e.g. for surgery, during the study
* Female p…
What they're measuring
1
The nominal and percent change in lesions counts from baseline to last available visit (end of treatment) and treatment success rates based on Investigator's assessment of mild to moderate acne