Phase I Study to Assess Irritation, Sensitization and Adhesion of a Novel Ibuprofen 200 mg TEPI Medicated Plaster

2018-08-23 21:26:16 | BioPortfolio


This trial will be conducted with the aim to investigate the dermal response (skin irritation, sensitization) and the adhesion of Ibuprofen 200 mg TEPI Medicated Plaster as compared to a Placebo TEPI Plaster in two phases:

Induction Phase: multiple dose application of one active and one placebo plaster on 5 consecutive days in which the plasters remain in place for 23 hours ± 30 min a day and Challenge Phase: single dose application of one active and one placebo plaster which remain in place for 48 hours ± 30 min.

Study Design




Ibuprofen 200 mg TEPI Medicated Plaster, Placebo TEPI Plaster


Not yet recruiting


Medherant Ltd

Results (where available)

View Results


Published on BioPortfolio: 2018-08-23T21:26:16-0400

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Medical and Biotech [MESH] Definitions

Dressings made of fiberglass, plastic, or bandage impregnated with plaster of paris used for immobilization of various parts of the body in cases of fractures, dislocations, and infected wounds. In comparison with plaster casts, casts made of fiberglass or plastic are lightweight, radiolucent, able to withstand moisture, and less rigid.

The process of producing a form or impression made of metal or plaster using a mold.

A calcium salt that is used for a variety of purposes including: building materials, as a desiccant, in dentistry as an impression material, cast, or die, and in medicine for immobilizing casts and as a tablet excipient. It exists in various forms and states of hydration. Plaster of Paris is a mixture of powdered and heat-treated gypsum.

Medicated dosage forms for topical application in the vagina. A cream is a semisolid emulsion containing suspended or dissolved medication; a foam is a dispersion of a gas in a medicated liquid resulting in a light, frothy mass; a jelly is a colloidal semisolid mass of a water soluble medicated material, usually translucent.

Procedure of producing an imprint or negative likeness of the teeth and/or edentulous areas. Impressions are made in plastic material which becomes hardened or set while in contact with the tissue. They are later filled with plaster of Paris or artificial stone to produce a facsimile of the oral structures present. Impressions may be made of a full complement of teeth, of areas where some teeth have been removed, or in a mouth from which all teeth have been extracted. (Illustrated Dictionary of Dentistry, 1982)

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