An exploratory study evaluating the efficacy of cromoglicate cream compared to cream vehicle in the treatment of itch in psoriasis

EO Pharma A/S0 sites30 target enrollmentSeptember 25, 2012

Overview

No summary available.

Registry

who.int

Start Date

September 25, 2012

End Date

April 11, 2013

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

EO Pharma A/S

•1\.Signed informed consent has been obtained
•2\.Age 18 years or above
•3\.Either sex
•4\.Any race or ethnicity
•5\.Attending hospital outpatient clinic or the private practice of a dermatologist
•6\.Clinical diagnosis of stable plaque psoriasis of at least 6 months with a symmetric distribution
•7\.Two treatment areas with a symmetrical distribution each corresponding to 2\-3% BSA and each including at least one itchy psoriasis plaque
•8\.Itchy psoriasis on both intended treatment areas of at least 40mm on the Visual Analogue Scale (VAS) with a maximum difference of 10mm on the visual ana\-logue scale between each of the two treatment areas
•9\.Disease severity graded mild, moderate or severe according to the Physician’s global assessment (PGA) of disease severity on psoriasis plaques on each of the two treatment areas. The disease severity must be the same for both treatment areas
•Are the trial subjects under 18? no

•1\.Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
•etanercept – within 4 weeks prior to randomisa\-tion
•adalimumab, infliximab – within 8 weeks prior to randomisation
•ustekinumab – within 16 weeks prior to randomisation
•other products – 4 weeks/5 half\-lives (whichev\-er is longer)
•2\.Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticoster\-oids, retinoids, methotrexate, ciclosporin, fumaric acid derivatives, and other immunosuppressants) within 4 weeks prior to randomization
•3\.Any topical treatment of the treatment areas (except for emollients) within 2 weeks prior to randomisation.
•4\.Treatment with therapies, whether marketed or not, with a possible effect on itch within the following time periods prior to randomisation:
•antihistamins – within 1 week prior to randomi\-sation
•gabapentin – within 4 weeks prior to randomi\-sation