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Table 1 Safety and efficacy evaluations

From: Diagnosis of O. volvulus infection via skin exposure to diethylcarbamazine: clinical evaluation of a transdermal delivery technology-based patch

Study day

−5 to −1

1

2

3

4

5

6

7

8

9

Medical and medication history

X

         

PE, height, 12-lead ECG

X

         

Weight

X

        

X

Vital signs(a)

X

X

X

X

X

X

X

X

X

 

Ocular examination(b)

X

 

X

 

X

 

X

 

X

 

Haematology, serum biochemistry, urinalysis(c)

X

   

X

   

X

 

Interim PE

    

X

   

X

 

Adverse events

 

X

X

X

X

X

X

X

X

 

Skin snip(d)

X

   

X

   

X

 

Patch application

 

OCP

   

LTS-2

    

Reaction readout(e)

  

X

X

  

X

X

  

Skin punch biopsy

  

X

   

X

   

Discharge

         

X

Day relative to OCP-patch application

−3

0

1

2

3

4

5

6

7

8

Day relative to LTS-2 patch application

−7

−4

   

0

1

2

3

4

  1. PE physical examination
  2. (a)Pulse rate, blood pressure, respiratory rate, and oral temperature measured after at least 5 min supine. 6 times/day during screening period, 2times/day on days 1–8
  3. (b)Visual acuity, visual fields using a calibrated Goldmann perimeter, colour vision, external ocular structures, ocular mobility and pupillary reflex. Anterior segment examination with Haag-Streit 900 slit-lamp. Microfilariae in anterior chamber counted after head-down positioning for 5 min. Count of living and dead microfilariae in cornea and punctuate opacities. Intraocular pressure, dilated fundus examination with direct and indirect ophthalmoscopy. Fundus photography and fluorescein angiography was planned only on subjects with abnormalities of visual function (visual acuity or visual fields) and was not indicated in any subject
  4. (c)Samples obtained in fasting state. Haematology: complete blood cell count (CBC), haematocrit, haemoglobin, WBC with manual differential, platelet count. Serum chemistry: sodium, potassium, chloride, carbon dioxide, glucose, total protein, albumin, blood urea, creatinine, alkaline phosphatase, lactic dehydrogenase (LDH), total bilirubin, gamma-glutamyl transpeptidase (GGT), aspartate aminotransferase (AST/SGOT), and alanine aminotransferase (ALT/SGPT). Urinalysis: 10-parameter dipstick (specific gravity, pH, protein, glucose, ketones, blood, bilirubin, urobilinogen, nitrite, leucocytes) and microscopic evaluation
  5. (d)Two skin snips from right and left iliac crests using a 2 mm Holth or Walser-type corneoscleral punch. Each snip was weighed on an analytical balance and incubated overnight in isotonic saline in a well of a flat-bottomed microtitre plate. Emerged mf were counted under inverted microscope. The skin mf density at each site was calculated per mg skin. Screening skin snips were obtained on Day −3
  6. (e)Local reaction reading on Day 2 and Day 6 occurred immediately after removal of the respective patch 24 h after its application and again 6 h later (i.e. 30 h after application of the respective patch and 6 h after its removal)
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Parasites & Vectors

ISSN: 1756-3305

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