Skin and Connective Tissue Diseases lymphatic filariasis, lymphedema
Conditions
Interventions
Treatment ¿DOX 200¿
Treatment ¿DOX 100¿
Treatment ¿Placebo¿ (control)
Treatment Group B ¿DOX 200¿
Treatment ¿Placebo¿ (control): B
Sponsors
Kumasi Centre for Collaborative Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Lymphedema of at least one leg Grade 1-6 measured on a 7-point scale [3] 2. Age ¿ 14 years and ¿ 65 years 3. Men or non-pregnant women. If women of childbearing-potential, they must use an approved, effective method of contraception (including abstinence) before, during and for at least 2 weeks after the completion of the active intervention with doxycycline or placebo 4. Negative pregnancy test 5. Body weight ¿ 40 kg 6. Resident in LF endemic area for ¿ 2 years 7. Able and willing to give informed consent to participate in the trial 8. Ability to use established standardized methods of hygiene and effectively applying it prior to the initiation of the drug treatment
Exclusion criteria
Exclusion criteria: 1. No lymphedema or lymphedema stage 7 2. Age 65 years 3. Body weight 2 times upper limit of normal 5. AST (GOT) > 2 times upper limit of normal 6. ALT (GPT) > 2 times upper limit of normal 7. y-GT > 2 times upper limit of normal 8. Positive urine pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lack of progression of LE (stage reduction or same stage as pre- treatment using the 7-point scale staging according to Dreyer e tal. examined 24 months after treatment onset | — |
Secondary
| Measure | Time frame |
|---|---|
| ¿ Lack of progression of LE (stage reduction or same stage as pre- treatment using the 7-point scale staging according to Dreyer et al examined 6 or 12 months after treatment onset | — |
Countries
Ghana
Contacts
Public ContactLinda Batsa
Coordinator
Outcome results
None listed