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Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834     Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za     Website: www.pactr.org

Trial no.: PACTR201306000522355 Date registered: 2013/03/15
TRIAL DESCRIPTION
Public title Essai squalamine
Official scientific title An evaluation of the tolerance and efficacy of Squalamine in the treatment of scalp ringworm or Tinea capitis in school aged children in Mali
Brief summary describing the background
and objectives of the trial
Efficacy and safety of a squalamine ointment for the treatment of tinea capitis was tested in Bamako (Mali) in a randomized controlled double-blind clinical trial that enrolled twenty school aged children, 5 in squalamine and 20 in placebo arms for three weeks. Primary endpoint was complete clinical cure. Clinical and mycological evaluations were done at day-0, 7 and 21. Hair-growth score was better (p=0.03) in children treated with squalamine compared to those treated with placebo
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied
Purpose of the trial Treatment
Anticipated trial start date 2011-05-02
Actual trial start date 2011-05-04
Anticipated date of last follow up 2011-06-25
Actual date of last follow up 2011-06-25
Anticipated target sample size (number of participants) 20   
Actual target sample size (number of participants) 20   
Recruitment status Completed: recruitment & data analysis complete
Secondary Ids Issuing authority/Trial register Links to Secondary ID

STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person
allocating the participants to the intervention arms
Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised simple randomization using a computer generated randomization list Allocation was determined by the holder of the sequence who is situated off site Masking/blinding used

INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental group Topical squalamine Once per day 21 days 20g of vaseline containing 1% squalamine 5
Control group Placebo Once per day 21 Days Ointment similar in aspect, color, consistence to test product 15 Placebo

ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Min age Max age Gender
Children aged between 6 and 15 years Sexe male Attending the primary school of Sirakoro-Meguetana Willingness to have hair shaved prior to treatment Confirmed clinical and mycological diagnosis of tinea capitis Consent provided by parents Children with dermatophyte infection of the skin Children who received a conventional or traditional (oral or topical) antifungal treatment within one month before the study Children with any grave medical condition that could interfere with compliance to study procedures 6 Years 15 Years Male

ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval
Name of the ethics committee
Yes 2010/12/22 Comité d'Ethique de la FMPOS
Ethics Committee Address
Street address City Postal code Country
Point G, BP 1805 Bamako Mali

OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mycological and clinical cure of tinea capitis lesions Measured 21 days after the first day of treatment
Secondary Outcome Occurence of local and systemic adverse events On study day 0 (day of first treatment), study days 7 and 21
Secondary Outcome Mycological cure Study day 21
Secondary Outcome Partical clinical response (aspect, size of tinea capitis lesions, hair growth score Study days 7 and 21

RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Fundamental school B of Sirakoro-Meguetana Ecole B Sirakoro-Meguetana BP 1805 Mali

FUNDING SOURCES
Name of source Street address City Postal code Country
Laboratoire de Parasitologie et de Mycologie de Marseille/Hôpital La Timone 264 Rue Saint-Pierre Marseille 13385 France
Université de Bamako/Département d'Epidémiologie des Affections Parasitaires Point G, BP 1805 Bamako Mali

SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Université de Bamako/Département d'Epidémiologie des Affections Parasitaires Point G, BP 1805 Bamako Mali University
Secondary Sponsor Laboratoire de Parasitologie et de Mycologie de Marseille/Hôpital La Timone 264 Rue Saint-Pierre Marseille 13385 France University

COLLABORATORS
Name Street address City Postal code Country
Ogobara K Doumbo Point G, BP 1805 Bamako Mali
Jean Gaudart UMR912, SESSTIM, INSERM Marseille 13385 France
Brunnel Jean Michel CRCM, CNRS, UMR7258 Marseille 13385 France
Abdoulaye A Djimde Point G, BP 1805 Bamako Mali
Pierre Traore Département de Dermatologie, CNAM, BP 251 Bamako Mali
Siaka Goita Point G, BP 1805 Bamako Mali
Abdoulaye K Kone Point G, BP 1805 Bamako Mali
Oumar Coulibaly IP-TPT, UMR MD3, Aix Marseille Université Marseille 13385 France
Ranque Stephane 264 Rue Saint-Pierre Marseille 13385 France
Piarroux Renaud 264 Rue Saint-Pierre Marseille 13385 France

CONTACT PEOPLE
Role Name Email Phone Fax
Principal Investigator Prof Mahamadou Ali Thera mthera@icermali.org +223 66740961
Street address City Postal code Country Position / Affiliation
Point G, BP 1805 Bamako Mali Professor of Parasitology-Mycology, University of Bamako
Role Name Email Phone Fax
Public Enquiries Prof Ogobara Doumbo okd@icermali.org +223 66753396
Street address City Postal code Country Position / Affiliation
Point G, BP 1805 Bamako Mali Head of Department, Director of MRTC
Role Name Email Phone Fax
Scientific Enquiries Dr Stephane Ranque Stephane.RANQUE@ap-hm.fr +33 491 38 6090 +33 491 3849 58
Street address City Postal code Country Position / Affiliation
264 rue Saint Pierre Marseille 13385 France Maitre Conférence des Universités - Praticien Hospitalier, Hôpital La Timone