A Double-Blind Randomized Placebo-Controlled Clinical Trial of Squalamine Ointment for tinea capitis Treatment

• Published in: Mycopathologia (1975) 2015-04, Vol.179 (3-4), p.187-193
• Main Authors: Coulibaly, Oumar, Thera, Mahamadou A., Koné, Abdoulaye K., Siaka, Goïta, Traoré, Pierre, Djimdé, Abdoulaye A., Brunel, Jean-Michel, Gaudart, Jean, Piarroux, Renaud, Doumbo, Ogobara K., Ranque, Stéphane
• Format: Article
• Language: English
• Subjects: Administration, Topical; Adolescent; Antifungal Agents - administration & dosage; Antifungal Agents - adverse effects; Applications; Arthrodermataceae - classification; Arthrodermataceae - drug effects; Arthrodermataceae - genetics; Arthrodermataceae - isolation & purification; Biomedical and Life Sciences; Blood Cell Count; Child; Cholestanols - administration & dosage; Cholestanols - adverse effects; Clinical trials; Dermatology; Double-Blind Method; Dynamical Systems; Ecology, environment; Emerging diseases; Environment and Society; Environmental Sciences; Eukaryotic Microbiology; Female; Follow-Up Studies; Fungal infections; Hair; Health; Human health and pathology; Humans; Infectious diseases; Life Sciences; Male; Mathematics; Medical Microbiology; Methodology; Microbial Ecology; Microbiology; Microbiology and Parasitology; Ointments - administration & dosage; Ointments - adverse effects; Parasitology; Plant Sciences; Probability; Santé publique et épidémiologie; Statistics; Tinea; Tinea Capitis - blood; Tinea Capitis - drug therapy; Tinea Capitis - microbiology; Treatment Outcome
• ISSN: 0301-486X; 1573-0832
• DOI: 10.1007/s11046-014-9849-y

Background Novel treatments against for tinea capitis are needed, and the natural aminosterol squalamine is a potential topical antidermatophyte drug candidate. Objectives This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis . Patients Males aged 6–15 years presenting with tinea capitis were treated with either topical squalamine ointment or placebo for 3 weeks. The primary endpoint was complete clinical cure. The secondary endpoints were the occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of clinical adverse events was performed daily. Results Five patients were treated with 1 % squalamine ointment and 15 with placebo. No complete cure was observed. No clinical or biological adverse event was recorded. A significantly ( p  = 0.03) better hair-growth score, indicating a partial clinical improvement of the tinea capitis lesion, was observed in the patients treated with squalamine compared to those treated with placebo. Conclusion This three-week squalamine ointment regimen was well tolerated and showed an encouraging partial clinical activity for the treatment of tinea capitis . Further studies are needed to evaluate the efficacy of topical squalamine alone against tinea corporis or in combination with a systemic antidermatophyte drug against tinea capitis .