Acne Vulgaris: Treatment with Azithromycin Kouzeva V, Hitova M, Dancheva A, Kaliasheva P City Center for Dermatovenerology, Sofia Bulgaria

INTRODUCTION I Acne Vulgaris is multifactor disease and there are lot of target places for therapeutic alleviation. The typical pathogenesis development of the disease is abnormal follicular keratinisation of the pilosebaceic unit, followed by sebum accumulation, which leads to the first lesions in acne: comedons. The colonization of Propionbacterium acnes in the comedons and the the followed inflammation, leads to lesions of which papules and pustules are features of the moderate acne papulopustulosis..

INTRODUCTION II Acne is not infectious disease, but the antibiotics have a major place in the therapeutic approaches of the treatment. Mechanisms of action of antibiotics against Acne are two: Reduction of the quantity of P.acnes and subsequent change of the ratio between free lipid acids compared to superficial lipids; Reduction of the free lipid acids trough inhibition of the bacterial lipases. The antibiotics used for the treatment of acne are requiring frequently dosing and are related to unwanted side effects.

METHODS I 1.PATIENT CHARACTERISTICS: NumberPercent of total Patients Nr % Male % Female % Age 12 –25 2.Treatment and dosing regimen: 3 times weekly -250mg of Azythromycin for 10 weeks.

 Moderate to severe acne papulopustulosis, with number of the lesions varying from 10 to 50, spread in the face, back and neck.  Patients should not be treated with antibiotics for acne therapy for the last 4 weeks.  Patients should not be treated with hormonal preparations for acne therapy for the last 3 months.  Patients should not be treated with topical anti-acne therapy for the last 4 weeks. METHODS II 3. Inclusion criteria:

METHODS III 4. Distribution of the patients, depending on the severity of Acne: Number of papulopustulosis Patients number Percent of the total % 20 – % 30 – % 40 – %

METHODS IV 5. Visits during the 24 weeks observation period: Visit 1 – Initial visit for the start of the therapy Visit 2 - on week 3 Visit 3 - on week 10 Visit 4 - on week 24 During the course of the treatment patients used topical non-comedonogenic dermatocosmetics.

 Reduction of the number of the lesions in the face,back and neck.  Patients subjective assessment for the therapeutic alleviation of acne. METHODS V 6. Criteria for evaluation of the treatment efficacy:

RESULTS I Patients number Percent Reduction of the number of the lesions % Reduction over 80% male % Reduction over 80% female % Reduction over 80% TOTAL % Reduction below 25% male % Reduction below 25% female % Reduction below 25% TOTAL % Evaluation on week 3 by Investigator

RESULTS II Patients number Percent Evaluation by the patients % Full treatment success % Very good improvement % Satisfactory improvement % Lack of improvement 00% Deterioration 00% Evaluation on week 3 by Patients

RESULTS III Patients number Percent Reduction of the number of the lesions % Reduction over 80% TOTAL % Reduction below 25% TOTAL % Evaluation on week 10 by Investigator

RESULTS IV Patients number Percent Evaluation by the patients % Full treatment success % Very good improvement % Satisfactory improvement 63.7% Lack of improvement 00% Deterioration 00% Evaluation on week 10 by Patients

RESULTS V Patients number Percent Reduction of the number of the lesions % Reduction over 80% TOTAL % Reduction below 25% TOTAL % Evaluation on week 24 by Investigator

RESULTS VI Patients number Percent Evaluation by the patients % Full treatment success % Very good improvement % Satisfactory improvement % Lack of improvement 63.7% Deterioration 63.7% Evaluation on week 24 by Patients

RESULTS VII DURING 10 WEEKS OF TREATMENT WERE NOT OBSERVED UNWANTED SIDE EFFECTS RELATED TO AZITHROMYCIN

 The results drawn by the study are showing the high efficacy of azithromycin in the treatment of Acne papulopustulosis.  Azithromycin is safe and well tolerated in real clinical settings.  Azithromycin is convenient for application – 1capsule of 250mg, 3 times a week for 10 weeks. CONCLUSIONS