Treatment of moderate-severe inflammatory acne MedDRA version: 9.1 Level: LLT Classification code 10000496 Term: Acne
Conditions
Interventions
Product Name: Azitromicina
Product Code: CP-62,933
Pharmaceutical Form: Powder and solvent for oral suspension
INN or Proposed INN: Azithromycin
Concentration unit: g gram(s)
Concentration type: equal
Sponsors
PFIZER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female subjects, older than 16 years, with diagnosis of acne papulo-pustolar or pustolar, moderate 19-30 GAGS score to severe 31-33 GAGS Score , graded by the score Global Acne Grading System GAGS 32 . - Written informed consent of the subject or a legally authorized representative. - Women of childbearing potential WOCBP must have a negative urine pregnancy test within 48 hours prior to start of study medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pregnant or lactating women. Patients with gastrointestinal diseases. Patients with endocrinological diseases. Patients in antibiotic treatment during 30 days prior to initiation of treatment with study drugs. Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study. Specific systemic diseases or other medical conditions, that would interfere with the evaluation of the therapeutic response or safety of the study drug. Patients using hormonal contraceptives within one month before study entry , or other therapies with sex hormone within one month before study entry , that could jeopardize the therapeutic response of the study drug. Patients treated with isotretinoin within six months before study entry. Patients currently using and cannot discontinue any topical drugs therapy for acne detergents allowed at least 24 hours before randomization. Alcohol and/or any other drug abuse. Previous participation in any other clinical trial with the study drug; A previous history of intolerance or hypersensitivity to the study drugs, including comparator. Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. Progressive fatal disease/life expectancy diseases. Severe disease, likely to jeopardize the planned termination of the study e.g., cancer, cardiac infarct, unstable angina pectoris . Abnormal baseline findings considered by the investigator to be indicative of conditions that might affect study results. Impaired hepatic function. Impaired renal function. Any other condition which, in the investigator s judgment might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Secondary objectives are to evaluate safety and tolerability of cyclical courses of Azithromycin microspheres administrations in outpatients with papulo-pustular acne, and to measure the impact on QoL of the treatment in patients with moderate to severe inflammatory acne.;Main Objective: The primary objective is to evaluate the clinical efficacy of Azithromycin microspheres treatment in outpatients with moderate to severe inflammatory acne papulo-pustolar , compared with the first line treatment minocycline, after 8 weeks of therapy.;Primary end point(s): Compare the means of GAG scores reduction between baseline and visit 2 end of treatment in the two treatment groups. | — |
Countries
Italy
Outcome results
None listed