A REPORT OF CLINICAL TRIAL CONDUCTED ON Тото OINTMENT: METHODOLOGY

Posted by James

This clinical trial was carried out in the medical outpatient department of the Ogun State University Teaching Hospital (OSUTH), Sagamu. Study participants also were recruited from area schools. Local ethical committee approval was obtained. This is a randomized, comparative, parallel, prospective, and blinded observational study.

• Inclusion criteria: Patient must be Nigerian and have any of the common skin diseases such as acne vulgaris, dandruff, scabies, fungal and bacterial skin infections.
• Exclusion Criteria: Patients with known hy-persensitivity/contraindication to sulfur; renal impairment; clinically significant abnormality of haematopoietic, hepatic, endocrine or cardiac function and existence of any concurrent disease, which in the investigator opinion would make it undesirable for the patient to participate in the study. Others include women of childbearing age who are not using an acceptable method of birth control; breast-feeding mothers; presence of psychosis, antagonist personality or poor motivation, emotional or intellectual property that is likely to impair compliance with trial procedures or validity of consent.

Consecutive subjects presenting with acne vulgaris, dandruff, scabies, fungal and bacterial skin infections were recruited. Informed consent was obtained from the patients. The study was conducted in accordance with the declaration of Helsinki, Hong Kong Revision (1989). All patients had baseline physical examination and diagnosis of skin ailmentmade. Blood samples were taken for routine investigations at first contact. Prior medications were documented. Subjects (patients) discontinued any skin medication (both oral and local) and were given placebo daily for two weeks. Newly diagnosed patients were placed on placebo for one week. kamagra jelly uk

Following the placebo run in/wash out period, patients were given either a Toto ointment, or a Toto Soap, or a combination of the ointment and soap, or sulfur ointment consecutively. The ointment and the soap were used twice daily. Soap use was preferred in patients with Tinea capitis more than patients with any other superficial skin condition for technical reasons-ease of application of the soap lather. Expressed preference for either the soap or the cream was at times taken into consideration. Baseline symptoms and signs were documented. Photographs of skin lesions, bacterial or fungal sampling (as indicated) were taken. Samples taken from patients in the surrounding schools were transported to the laboratory in an appropriate transport media.

At the end of four weeks, the patients were reevaluated. Returned containers were used to ascertain compliance. At each visit, all patients were reviewed to assess cure (clinical success) rates. Clinical success was taken as disappearance of lesions and/or negative mycological/bacteria results. Adverse drug effects were recorded after the run-in period in response to the question, “have you had any symptoms, problems, or feeling of being unwell since your last visit?” antibiotics online pharmacy

A questionnaire was administered to each patient to obtain information on the progress of healing, presence of observable side effects and the acceptability of the ointment and the soap (appearance, smell, dosing and method of administration). The patients were reviewed after 12 weeks further assessing cure rates, relapse, and laboratory parameters were repeated.

Fungi were demonstrated in specimens on microscopic observation of wet mounts in 10% potassium hydroxide solution and also isolated in pure cultures on Sabouraud 2% dextrose agar (SAB) containing 0.5mg/ml of cycloheximide and 0.016mg/ml of chloramphenicol drug. Isolates were identified using standard mycology methods. Bacteriologic cultures were made on Oxoid blood agar and Biotec MacConkey agar plates by the streak plate method using sterile standard 4mm internal diameter platinum wire loops, and incubating at 37° С aerobically for 24 to 48 hours. Bacteria were identified using standard microbiologic techniques.

Data analysis was done by comparing means using the Chi-square test and significant differences taken as p < 0.05. canadian antibiotics