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A Double-Blind Randomized Placebo-Controlled Clinical Trial of Squalamine Ointment for tinea capitis Treatment
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A Double-Blind Randomized Placebo-Controlled Clinical Trial of Squalamine Ointment for tinea capitis Treatment
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Journal Article
A Double-Blind Randomized Placebo-Controlled Clinical Trial of Squalamine Ointment for tinea capitis Treatment
2015
Overview
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
.
Publisher
Springer Netherlands,Springer,Springer Nature B.V,Springer Verlag
Subject
/ Antifungal Agents - administration & dosage
/ Antifungal Agents - adverse effects
/ Arthrodermataceae - classification
/ Arthrodermataceae - drug effects
/ Arthrodermataceae - genetics
/ Arthrodermataceae - isolation & purification
/ Biomedical and Life Sciences
/ Child
/ Cholestanols - administration & dosage
/ Cholestanols - adverse effects
/ Female
/ Hair
/ Health
/ Humans
/ Male
/ Microbiology and Parasitology
/ Ointments - administration & dosage
/ Santé publique et épidémiologie
/ Tinea
/ Tinea Capitis - drug therapy
