The purpose of this study is to evaluate if the investigational medicinal product CHRONSEAL intended for future treatment of chronic venous leg ulcers is safe and tolerated and if it has an ulcer size reduction effect when administered to individuals suffering from venous leg ulcers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
75
Cream (1.4/2.8 g depending on ulcer size) topical administration, every 2nd day at 3 occasions
Medi3 Innlandet AS, Department Elverum
Elverum, Norway
Hudavdelingen Helse
Førde, Norway
Medi 3 Innlandet AS, Department Hamar
To investigate safety and local tolerance of CHRONSEAL® cream containing 2 different concentrations of API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.
Time frame: From start of treatment to 12 weeks post treatment
To investigate the treatment effect on ulcer area reduction and changes of ulcer condition of CHRONSEAL® cream, containing 2 different concentrations API, applied at 3 occasions every second day in chronic venous leg ulcers compared to vehicle.
Time frame: From start of treatment to 12 weeks post treatment
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Hamar, Norway
Colosseumklinikken
Oslo, Norway
Vårdcentralen Alvesta
Alvesta, Sweden
Danderyds Sjukhus AB
Danderyd, Sweden
Carema Vårdcentral Gubbängen
Enskede, Sweden
Department of Dermatology and Infectious diseases
Halmstad, Sweden
Husläkarna i Kungsbacka
Kungsbacka, Sweden
Department of Dermatology, Lund University hospital
Lund, Sweden
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