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: pactr.samrc.ac.za
Trial no.: PACTR201306000522355 Date of Approval: 15/03/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
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 Dermatophytosis,Paediatrics,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 02/05/2011
Actual trial start date 04/05/2011
Anticipated date of last follow up 25/06/2011
Actual Last follow-up date 25/06/2011
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants) 20
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
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
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 Care giver/Provider,Outcome Assessors,Participants
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 Age Category Minimum age Maximum 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 Year(s) 15 Year(s) 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 22/12/2010 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
Ranque Stephane 264 Rue Saint-Pierre Marseille 13385 France
Piarroux Renaud 264 Rue Saint-Pierre Marseille 13385 France
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
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mahamadou Ali Thera mthera@icermali.org +223 66740961 Point G, BP 1805
City Postal code Country Position/Affiliation
Bamako Mali Professor of Parasitology-Mycology, University of Bamako
Role Name Email Phone Street address
Public Enquiries Ogobara Doumbo okd@icermali.org +223 66753396 Point G, BP 1805
City Postal code Country Position/Affiliation
Bamako Mali Head of Department, Director of MRTC
Role Name Email Phone Street address
Scientific Enquiries Stephane Ranque Stephane.RANQUE@ap-hm.fr +33 491 38 6090 264 rue Saint Pierre
City Postal code Country Position/Affiliation
Marseille 13385 France Maitre Conférence des Universités - Praticien Hospitalier, Hôpital La Timone
REPORTING
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
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