Phase 1
N=24
A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris
Psoriasis Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT01580488 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcome: Primary: Change in the Total Clinical Score From Baseline to Day 22 — -2.8; -1.9; -1.5; -1.8 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- B LEO 35299 20 mg/g cream (Drug); C LEO 35299 20 mg/g cream (Drug); E LEO 35299 10 mg/g solution (Drug); F LEO 35299 10 mg/g solution (Drug); Daivonex® ointment (Drug); Daivonex® ointment vehicle (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in the Total Clinical Score From Baseline to Day 22 |
-2.8; -1.9; -1.5; -1.8; -4.0; -3.3 | — |
| SECONDARY Change in Erythema From Baseline to Day 22 |
-0.91; -0.67; -0.54; -0.70; -1.09; -1.07 | — |
| SECONDARY Change in Infiltration From Baseline to Day 22 |
-0.87; -0.59; -0.46; -0.46; -1.48; -1.11 | — |
| SECONDARY Change in Scaling From Baseline to Day 22 |
-1.09; -0.74; -0.61; -0.67; -1.52; -1.30 | — |
| SECONDARY Change in Lesion Thickness From Baseline to Day 22 |
-0.31; -0.18; -0.22; -0.24; -0.36; -0.38 | — |
| SECONDARY Change in Skin Thickness From Baseline to Day 22 |
-0.40; -0.29; -0.24; -0.40; -0.57; -0.49 | — |
Summary
The purpose of the study is to evaluate the anti-psoriatic effect of LEO 35299 in different formulations, compared to Daivonex® ointment and Daivonex® ointment vehicle, using the psoriasis plaque test modified from the method developed by KJ Dumas and JR Scholtz.
Eligibility Criteria
Inclusion Criteria
- Following verbal and written information about the trial, the subject must provide signed and dated informed consent before any study related activities are carried out.
- Age 18 years or above.
- Males, or females of non-child bearing potential.
- Subjects with, in the opinion of the investigator, stable psoriasis based on Total Plaque Score evaluated at screening visit and at visit 2 (Baseline).
Exclusion Criteria
- Male subjects who are not willing to use a local contraception (such as condom) from the time of study entry and for three months following the last study drug application.
- Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
- 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 islonger) for experimental biological products prior to randomisation and during the study.
- Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immune suppressants) within the 4-week period prior to randomisation and during the study.
- Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the study:
- Potent or very potent (WHO group III-IV) corticosteroids.
- Subjects using of phototherapy within the following time periods prior to randomisation and during the study:
- PUVA (4 weeks)
- UVB (2 weeks)
- Subjects using one of the following topical drugs for the treatment of psoriasis within two weeks prior to randomisation and during the study:
- WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
- Topical retinoids
- Vitamin D analogues
- Topical immunomodulators (e.g. macrolides)
- Anthracen derivatives
- Tar,
- Salicylic acid.
- Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
- Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the 4 week period prior to randomisation or longer, if the class of the substance requires a longer washout as defined above (e.g., biological treatments)
- Subjects with current participation in any other interventional clinical, based on interview of the subject
Data sourced from ClinicalTrials.gov (NCT01580488). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.