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.: PACTR201505001116484 Date of Approval: 25/04/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy, Safety and Cost Effectiveness of Four Therapeutic Agents for Treatment of Scabies
Official scientific title Efficacy, Safety and Cost Effectiveness of Four Therapeutic Agents for Treatment of Scabies
Brief summary describing the background and objectives of the trial Scabies is a common parasitic infection caused by the mite Sarcoptes scabiei. Clinical infection with the scabies mite causes discomfort and often intense itching of the skin, particularly at night, with irritating papular or vesicular eruption. The aim of this study is to evaluate four drugs for treatment of scabies as regard the efficacy, safety and cost effectiveness. The study included 200 patients with scabies, 84 males and 116 females with age ranging between 7-50 years. The participants were diagnosed as cases of scabies by clinical examination which confirmed by parasitological examination.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied scabies,Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 04/11/2012
Actual trial start date 19/11/2012
Anticipated date of last follow up 04/05/2013
Actual Last follow-up date 19/05/2013
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants) 200
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 randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ivermectin 200 µg/kg body weight taken with meals, repeated after one week single oral dose treatment 50
Experimental Group Sulfur ointment 10 percent ointment for adults; 5percent for children below 10 yrs applied and left overnight to whole body below neck for 5 consecutive nights local treatment 50 Active-Treatment of Control Group
Experimental Group Permethrin lotion 5% lotion for adults, and 2.5% for children below 10 years applied and left overnight to the whole body below neck for five consecutive nights treatment 50
Control Group Benzyle Benzoate 20 percent cream cream aapplied and left overnight to whole body below neck five consecutive nights treatment 50 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
scabies; patients experiencing itching that involved at least three distinct sites on the body and had lesions that were characteristic of scabies history of nocturnal itching history of involvment of family members history of contact with scabies pateint presence of classical burrows on clinical examination presence of typical scabietic lesions like,papules, nodules and vesicles either gender above 5years of age willing to participate Pregnant or lactating women. Children < 5 years old and adult >50 years old. body weight less than 15 kg. Participants had a general condition such as abnormal liver and kidney functions, known thyroid disease, cardiac disorders, nervous system disorder, and psychiatric illnesses. participants with history of diabetes mellitus, hypertension, or chronic infectious diseases. Participants with any other associated skin disease, which could alter the picture of scabies. immunocompromised individuals, having scabies with atypical presentations like crusted scabies. Participants who had taken any antiscabetic treatment in the preceding month. 5 Year(s) 50 Year(s) Both
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 04/11/2012 Faculty of Medicine, Fayoum University, Ethics Committee
Ethics Committee Address
Street address City Postal code Country
ElGamaa street Fayoum 63513 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome complete absence of new lesions at the time of follow up and by negative parasitological examination of the patient at days 7 and 14 of follow up
Secondary Outcome adverse drug reaction at days 7 and 14 follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dermatology outpatient clinic at Fayoum University Hospital El Gamaa street fayoum 63513 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of medicine fayoum 63513 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Faculty of medicine Fayoum 63513 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Tamiaa Hospital Tamiaa Tamiaa 63513 Egypt
Senors Hospital Senors Senors 63513 Egypt
Senors Hospital, Tamiaa Hospital Senors st., Tamiaa st. Senors, Tamiaa 63513 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Eman Meabed emeabed@gmail.com +201008981791 El Gamaa st Keman Faris
City Postal code Country Position/Affiliation
Fayoum 63513 Egypt Associate professor Parasitology, Faculty Medicine, Fayoum Univ Egypt
Role Name Email Phone Street address
Public Enquiries Talal Abdel-Raheem talalsam@yahoo.com +201006600360 El Gamaa st Keman Faris
City Postal code Country Position/Affiliation
Fayoum 63513 Egypt Prof Dermatology, STD and Andrology, Faculty Medicine Univ Fayoum Egypt
Role Name Email Phone Street address
Scientific Enquiries Talal Abdel0Raheem talalsam@yahoo.com +201006600360 El Gamaa st Keman Faris
City Postal code Country Position/Affiliation
Fayoum 63513 Egypt Prof Dermatology,STD and Andrology, Faculty Medicine Fayoum Univ Egypt
REPORTING
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