Clinical trial NCT01580488: A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris
Official title: A Plaque Test Study With LEO 35299 in Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2012-04-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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:

1. 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.
2. Age 18 years or above.
3. Males, or females of non-child bearing potential.
4. 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:

1. 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.
2. Female subjects who are pregnant, of child-bearing potential or who are breast feeding.
3. 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.
4. 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.
5. 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.
6. Subjects using of phototherapy within the following time periods prior to randomisation and during the study:

   * PUVA (4 weeks)
   * UVB (2 weeks)
7. 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.
8. Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
9. Subjects with known/suspected disorders of calcium metabolism associated with hypercalcemia within the last 10 years, based on medical history and/or subject interview
10. 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)
11. Subjects with current participation in any other interventional clinical, based on interview of the subject

Primary outcomes:
measure: Change in the Total Clinical Score From Baseline to Day 22
timeFrame: Baseline to Day 22
Secondary outcomes:
measure: Change in Erythema From Baseline to Day 22
timeFrame: Baseline to Day 22
measure: Change in Infiltration From Baseline to Day 22
timeFrame: Baseline to Day 22
measure: Change in Scaling From Baseline to Day 22
timeFrame: Baseline to Day 22
measure: Change in Lesion Thickness From Baseline to Day 22
timeFrame: Baseline to Day 22
measure: Change in Skin Thickness From Baseline to Day 22
timeFrame: Baseline to Day 22
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD) - Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière
Study officials:
affiliation: Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD), Hôpital l'Archet 2, 151 route Saint-Antoine de Ginestière 06202 Nice Cedex 3, France
name: Catherine Queille-Roussel, MD
role: PRINCIPAL_INVESTIGATOR
References: