A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris (NCT01607853) | Clinical Trial Compass
CompletedPhase 2
A Short-contact Plaque Test Study With Daivobet® Gel in Psoriasis Vulgaris
France24 participantsStarted 2012-06
Plain-language summary
The purpose of this study is to evaluate the anti-psoriatic effect of Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes), Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) compared with Daivobet® gel and Daivobet® gel vehicle applied for 24 hours (+/- 2 hours), using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
âś“. Following verbal and written information about the trial, the subject has to provide signed and dated informed consent before any study related activities are carried out.
âś“. Age 18 years or above.
âś“. Either sex.
âś“. All skin types.
âś“. Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 4 different products.
âś“. Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (baseline).
✓. Subjects with psoriasis lesions (plaques) assessed by a Total Clinical Score (sum of scores of erythema, scaling and infiltration) of 4 to 9 inclusive, but each individual item ≥ 1.
âś“. Subjects willing and able to follow all the study procedures and complete the whole study.
Exclusion criteria
âś•. Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
âś•. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis vulgaris within 4 weeks (etanercept), 2 months (adalimumab, alefacept, infliximab), 4 months (ustekinumab) or 4 weeks/5 half-lives (which-ever is longer) for experimental biological products prior to randomisation and during the study.
What they're measuring
1
Change in Total Clinical Score From Baseline to Day 22
. Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4- week period prior to randomisation and during the study.
âś•. Use of phototherapy within the following time periods prior to randomisation and during the study:
âś•. Subjects using one of the following topical drugs within 4 weeks prior to randomisation and during the study:
âś•. Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the study:
âś•. Subjects using emollients on the target plaques within one week before randomisation and during the study.
âś•. Initiation of, or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study.