Azithromycin SR versus minocycline in the treatment of moderate to severe acne: a phase III, multicentre, randomized, non-inferiority trial

Introduction: The primary objective of this phase III, multicentre, randomized trial was to evaluate whether azithromycin SR (azithromycin microspheres, powder for oral suspension) was non-inferior to oral minocycline in the treatment of moderate to severe acne. The primary efficacy endpoint was the change from baseline in the GAGS score. Secondary endpoints included changes from baseline in the Leeds score and quality of life (QoL). Methods: A total of 118 patients were randomized (1:1) to receive azithromycin SR (2 g/week) (n = 58) or minocycline (100 mg q.d.) (n = 60) for eight weeks. Results: The change from baseline to end of treatment in GAGS score did not differ significantly between the azithromycin SR and minocycline groups [least squares mean -8.69 (95% confidence interval [CI]: -10.33 to -7.05) and -9.16 (95% CI: -10.62 to -7.71), respectively], consistent with the noninferiority of azithromycin SR to minocycline. The lower limit of 95% confidence interval of the change from baseline to end of treatment in GAGS scores between the 2 groups (95% CI: -2.48 to 1.54) did not exceed the pre-defined non-inferiority margin of -3. In addition, there were no significant differences in improvement of acne graded by the Leeds score and QoL. Twenty-six patients (44.8%) in the azithromycin SR group and 9 patients (15%) in the minocycline group reported gastro-intestinal disorders. Conclusions: In patients with moderate to severe acne, azithromycin SR is non-inferior to minocycline for primary endpoint (GAGS score), with no significant differences in secondary endpoints

Clindamycin phospate-zinc acetate versus clindamycin phosphate-zinc acetate + adapalene in the treatment of mild to moderate acne. Results of a multicentre, randomized, retrospective, sponsor-free study

Introduction: The aim of the present study was to evaluate the efficacy and the response in patients with mild to moderate acne of a clindamycin phosphate-zinc acetate topical therapy in comparison with clindamycin phosphate-zinc acetate plus adapalene. Methods: Patients with mild to moderate acne were randomized into two groups and treated, respectively, with a gel containing 1 % clindamycin phosphate-0.5% zinc acetate (2 applications/day for 12 weeks) or with the same gel (1 application/day for 12 weeks) plus a gel containing 0.1% adapalene (1 application/day for 12 weeks). No other topical or systemic drugs were allowed, except for a detergent and a sunscreen. Acne severity and treatment efficacy were evaluated by means of the Global Acne Grading System (GAGS). Results: At the end of the study, 63 patients were considered evaluable (29 patients in the group treated with clindamycin-zinc and 34 in the group treated with clindamycin-zinc and adapalene). Significant clinical improvement (maggiore/uguale 50% from baseline) was observed in 12/29 patients (41.4%) in the group treated with clindamycin-zinc and in 22/34 patients (64.7%) in the group treated with clindamycin-zinc and adapalene (p< 0.05). Irritant contact dermatitis was observed in 12 patients (3 in the group treated with clindamycin-zinc and 9 in the group treated with clindamycin-zinc and adapalene); in the latter group, two patients stopped the treatment. Conclusions: On the basis of the results of this study, which is the first one on the activity and tolerability of the association clindamycin-zinc, the latter association is less effective than the association clindamycin-zinc and adapalene

Prevention of relapses in patients previously treated with oral isotretinoin for severe acne. Results of a multicentre, randomized, retrospective, sponsor-free study

Introduction: After a systemic treatment with oral isotretinoin, acne therapy must be continued with topical products in order to avoid possible relapses. The aim of this study was to assess whether a topical retinoid is an effective choice in the prevention of relapses. Methods: Patients who were successfully treated with oral isotretinoin for severe acne, at the end of the therapy were randomized into two groups: the first one was treated with a topical retinoid (0.05% tretinoin or 0.05% isotretinoin or 0.1 % adapalene, 1 application/day for 6-8 months); the second group was not treated (only detergents and moisturizers were allowed). Follow up was >6 months. Results: At the end of the study, 2/37 patients (5.4%) treated with topical retinoids developed a relapse; in the group of patients who were not treated, 7/31 patients (22.6%) developed a relapse (p< 0.05). Conclusions: On the basis of the results of this study, topical retinoids are helpful in the prevention of relapses of acne in patients previously treated with oral isotretinoin

Unilateral sacroiliitis associated with systemic isotretinoin treatment

Acne fulminans is the most severe form of inflammatory acne characterized by the acute onset of inflammatory nodules and plaques, most commonly on the chest and the back. The lesions undergo rapid suppuration, leaving ragged hemorrhagic ulcers. Typically, it affects adolescent males with a history of mild to moderate acne. The affected patients often have constitutional symptoms such as fever, malaise, arthralgias, and myalgias. Leukocytosis is commonly associated. Sacroiliitis is reported in 21% of acne fulminans patients in association with arthritis and in a few cases it is reported during isotretinoin treatment, suggesting the drug triggering. CONCLUSION: We report a case of a young male patient in whom the induction of acne fulminans by systemic isotretinoin was associated with unilateral sacroiliitis