AUS DEM SCHWEIZERISCHEN TROPENINSTITUT BASEL UND DER UNIVERSITÄTS-HAUTKLINIK DER ALBERT-LUDWIGS-UNIVERSITÄT FREIBURG I.BR. EFFICACY OF TRICLOSAN SOAP AGAINST SUPERFICIAL DERMATOMYCOSES AND SCABIES - A PLACEBO- CONTROLLED STUDY AMONG 228 PRIMARY SCHOOL CHILDREN IN KILOMBERO DISTRICT, MOROGORO REGION, TANZANIA INAUGURAL-DISSERTATION ZUR ERLANGUNG DES MEDIZINISCHEN DOKTORGRADES DER MEDIZINISCHEN FAKULTÄT DER ALBERT-LUDWIGS-UNIVERSITÄT FREIBURG I.BR. VORGELEGT 2005 VON ALMUTH DINKELA GEBOREN IN ROTENBURG (WÜMME) DEKAN PROF. DR. C. PETERS 1. GUTACHTER PD DR. C. HATZ 2. GUTACHTER PROF. DR. L. BRUCKNER-TUDERMAN JAHR DER PROMOTION 2006 STUDIENKOORDINATOR: PD DR. MED. C. HATZ LEITENDER ARZT MEDIZIN UND DIAGNOSTIK SCHWEIZERISCHES TROPENINSTITUT UNIVERSITÄT BASEL SCHWEIZ MITGLIEDER DES DISSERTATIONSKOMITEES: PROF. DR. MED. L. BRUCKNER-TUDERMAN GESCHÄFTSFÜHRENDE DIREKTORIN UNIVERSITÄTS-HAUTKLINIK ALBERT-LUDWIGS-UNIVERSITÄT FREIBURG I.BR. DEUTSCHLAND PD DR. MED. P. SCHMID-GRENDELMEIER LEITENDER ARZT DER ALLERGIESTATION DERMATOLOGISCHE KLINIK UND POLIKLINIK UNIVERSITÄTSSPITAL ZÜRICH SCHWEIZ DR. W. BASCHONG SCIENTIFIC LIASONS & BIOLOGICAL STUDIES HOME AND PERSONAL CARE SEGMENT CIBA SPECIALTY CHEMICALS INC. SCHWEIZ PROF. DR. PHIL. M. TANNER INSTITUTSVORSTHER SCHWEIZERISCHES TROPENINSTITUT UNIVERSITÄT BASEL SCHWEIZ STUDIENKOORDINATOR AM IHRDC, IFAKARA/TANZANIA: DR. B. IDINDILI FACHARZT FÜR DERMATOLOGIE AM SFDDH, IFAKARA/TANSANIA: DR. M. MBATA UNTERSTÜTZUNG DER STATISTISCHEN AUSWERTUNG: DR. T. A. SMITH, DR. P. VOUNATSOU FÜR MEINE ELTERN “song of lawino – song of ocol” Ring-worm sometimes eats up A little girl’s hair And this is terrible; But when hot porridge Is put on the head And a dance is held Under the sausage-fruit tree And the youths have sung You, Ring-worm, Who is eating Duka’s hair, Here is your porridge, Then the girl’s hair Begins to grow again, And the girl is pleased. Okot p’Bitek LIST OF ABBREVIATIONS – IN ALPHABETICAL ORDER ............................................15 ACKNOWLEDGEMENTS – IN ALPHABETICAL ORDER ...............................................16 SUMMARY ........................................................................................................................17 ZUSAMMENFASSUNG.....................................................................................................18 INTRODUCTION ...............................................................................................................19 1. Superficial dermatomycoses ......................................................................................19 1.1 Tinea versicolor (synonym: Pityriasis versicolor) ................................................................................................. 19 1.2 Dermatophyte infections (synonym: Ringworm infections) .................................................................................. 22 1.2.1 Tinea capitis........................................................................................................................................................ 22 1.2.2 Tinea corporis ..................................................................................................................................................... 24 1.2.1 and 1.2.2 Diagnosis............................................................................................................................................. 24 1.2.3 Tinea pedis.......................................................................................................................................................... 25 1.2.5 Tinea manuum .................................................................................................................................................... 26 1.2.6 Tinea unguium .................................................................................................................................................... 26 1.3 Scabies .......................................................................................................................27 2. Information about Triclosan .......................................................................................28 2.1 Properties ............................................................................................................................................................... 29 2.2 Triclosan-containing products currently in use in Africa....................................................................................... 32 METHODS.........................................................................................................................33 1. Study Area....................................................................................................................33 2. Selection of Primary Schools .....................................................................................34 3. Screening Examinations .............................................................................................34 4. Admission to the Study...............................................................................................37 4.1 Inclusion Criteria ................................................................................................................................................... 37 4.2 Excludsion Criteria ................................................................................................................................................ 37 5. Case Definitions...........................................................................................................38 6. Degree of Infection ......................................................................................................40 7. Randomisation.............................................................................................................41 8. Follow-up Examinations..............................................................................................42 9. Evaluation of Effectiveness - Dermatomycoses .......................................................43 9.1 General................................................................................................................................................................... 43 9.2 Pruritus................................................................................................................................................................... 43 9.3 Clinical and Microscopic Resolution..................................................................................................................... 44 9.4 Definition of Evaluation Categories at Second Follow-up .................................................................................... 44 10. Evaluation of Effectiveness - Scabies......................................................................46 11. Assessment of Soap Use (Compliance) ..................................................................46 12. Determination of Minimal Inhibitory Concentrations (MIC’s) of Placebo Soap and of Triclosan ......................................................................................................................48 13. Data Entry and Analysis............................................................................................49 14. Additional Information...............................................................................................50 RESULTS ..........................................................................................................................51 1. GENERAL INFORMATION ...........................................................................................51 2. EPIDEMIOLOGY OF SUPERFICIAL DERMATOMYCOSES .......................................51 2.1 Prevalence rates ........................................................................................................51 2.2 Prevalence rates and degree of infection according to sex...................................52 2.2.1 Tinea versicolor .................................................................................................................................................. 52 2.2.2 Other superficial dermatomycotic infections ...................................................................................................... 53 2.3 Prevalence rates and degree of infection according to age groups .....................54 2.3.1 Tinea versicolor .................................................................................................................................................. 54 2.3.2 Other superficial dermatomycotic infections ...................................................................................................... 54 3. ASSESSMENT OF THE EFFECT OF SOAP ................................................................55 3.1 Assessment of the efficacy of Triclosan in soap....................................................55 3.1.1 Tinea versicolor infections.................................................................................................................................. 59 3.1.2 Other superficial dermatomycotic infections: Tinea capitis, corporis and pedis infections................................67 3.2 Determination of minimal inhibitory concentrations (MIC’s) of placebo soap and of Triclosan .......................... 76 4. SCABIES.......................................................................................................................81 4.1 Epidemiology and Study population.....................................................................................................................