To determine the safety, tolerability and systemic absorption of Diethylcarbamazine (DEC) from a patch applied locally to the skin for the diagnosis of Onchocerca volvulus infection (Clinical trials of drugs for onchocerciasis) (Ghana)

Not Applicable

Completed

• Conditions: Onchocerciasis; Infections and Infestations

• Registration Number: ISRCTN76875372
• Lead Sponsor: ICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06-07
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

1. Males in good general health, with O. volvulus infection
2. Written, signed and dated informed consent
3. Age 18 to 55 years
4. Weight over 40 kg
5. Healthy as determined by medical history, physical exam, Electrocardiogram (ECG) and clinical lab results
6. Adequate lab functions:
6.1. White Blood Cell count (WBC) more than 3,500 and 12,000 cells/ml
6.2. Haemogloblin (Hb) more than 11.0 g/dl
6.3. Platelets count more than 110,000 mm^3
6.4. Serum creatinine less than 1.25 x Upper Limit of Normal (ULN)
6.5. Total bilirubin less than 1.25 x ULN
6.6. Aspartate Transaminase (AST)/Serum Glutamic Oxaloacetic Transaminase (SGOT) less than 1.25 x ULN
6.7. Alkaline Phosphatase (AP) more than 1.25 x ULN
7. Skin microfilarial (mf) density of 5 to 15 mg as determined at the iliac crests

Exclusion Criteria

1. Ocular onchocerciasis
2. Hyper-reactive onchodermatitis
3. Skin lesions over iliac crests
4. Coincidental infection with Mansonella streptocera
5. Significant Electrocardiogram (ECG) abnormalities or history of cardiac abnormality
6. History of drug or alcohol abuse
7. Any other condition that the investigator feels would exclude the subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified