Clinical trial NCT00875277: A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
Official title: A Psoriasis Plaque Test Comparing LEO 29102 Cream and Its Different Combinations to Daivobet® Ointment and a Vehicle Control for the Treatment of Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2009-04-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this trial is to evaluate the anti-psoriatic effect of LEO 29102 cream and its combination with calcipotriol and betamethasone using a psoriasis plaque test method.


Eligibility criteria: Inclusion Criteria: (in summary)

* Subjects having understood and signed an informed consent form
* All skin types
* Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk. The lesions must have a total size suitable for application. The subjects should be asked if their lesions have been stable
* Subjects willing and able to follow all the study procedures and complete the whole study
* Subjects affiliated to social security system

Exclusion Criteria: (in summary)

* Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding
* Subjects using biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to study drug administration
* Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D-analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
* Subjects using one of the following topical drugs for the treatment of psoriasis within four (4) weeks prior to study drug administration: - Potent or very potent (WHO group III-IV) corticosteroids - PUVA or Grenz ray therapy
* Subjects using one of the following topical drugs for the treatment of psoriasis within two (2) weeks prior to study drug administration: - WHO group I-II corticosteroids - Topical retinoids - Vitamin D-analogues - Topical immunomodulators (e.g. macrolides) - Anthracen derivatives - Tar - Salicylic acid - UVB therapy
* Subjects with skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds within the plaque test areas

Primary outcomes:
measure: Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1)
timeFrame: From baseline (Day 1) to end of treatment (Day 29)
Secondary outcomes:
measure: Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline
timeFrame: From baseline (Day 1) to end of treatment (Day 29)
measure: Change in Erythema Compared to Baseline
timeFrame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22 and Day 25
measure: Change in Scaling Compared to Baseline
timeFrame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
measure: Change in Infiltration Compared to Baseline
timeFrame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
measure: Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline
timeFrame: At Day 4, Day 8, Day 11, Day 15, Day 18, Day 22, and Day 25
measure: Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound
timeFrame: At Day 8, Day 15, Day 22 and end of treatment
measure: Biomarkers by Immunochemistry
timeFrame: At end of treatment
measure: Biomarkers by Immunochemistry: Epidermal Differentiation
timeFrame: At end of treatment
measure: Biomarkers by Immunochemistry: Epidermal Proliferation
timeFrame: At end of treatment
measure: Pathology and Histology by Treatment
timeFrame: At end of treatment
measure: Pathology and Histology by Treatment: Epidermal Thickness
timeFrame: At end of treatment
measure: Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses
timeFrame: At end of treatment
Other outcomes:
Locations:
city: Saint-Quentin-en-Yvelines
country: France
facility: LEO Pharma site
Study officials:
affiliation: LEO Pharma
name: Director, International Clinical Development, MD
role: STUDY_DIRECTOR
References: