Phase 2
N=24
A Psoriasis Plaque Test With LEO 29102 Cream and Its Combination Products
Psoriasis Vulgaris
Bottom Line
View on ClinicalTrials.gov: NCT00875277 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) — -1.60; -4.96; -3.04; -3.96 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- LEO 29102 cream (Drug); LEO 29102 Cream Vehicle (Drug); Betamethasone Dipropionate Cream (Drug); LEO 29102 Plus Calcipotriol Cream (Drug); LEO 29102 Plus Betamethasone Dipropionate (Drug); Daivobet® Ointment (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- LEO Pharma
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline (Day 1) |
-1.60; -4.96; -3.04; -3.96; -5.56; -6.10 | <0.001 sig |
| SECONDARY Change in Single Clinical Symptom Score: Erythema, Scaling, Infiltration Compared to Baseline |
-0.42; -1.71; -0.90; -1.19; -1.85; -1.88 | — |
| SECONDARY Change in Erythema Compared to Baseline |
-0.04; -0.21; -0.02; -0.08; -0.40; -0.38 | — |
| SECONDARY Change in Scaling Compared to Baseline |
-0.17; -0.31; -0.13; -0.21; -0.33; -0.52 | — |
| SECONDARY Change in Infiltration Compared to Baseline |
-0.06; -0.10; -0.04; 0.00; -0.27; -0.29 | — |
| SECONDARY Change in Total Clinical Score (TCS) of the Clinical Symptoms Compared to Baseline |
-0.27; -0.63; -0.19; -0.29; -1.00; -1.19 | — |
| SECONDARY Ultrasonography: Change in Lesions Thickness From Baseline Measured by Ultrasound |
0.05; -0.14; 0.03; 0.00; -0.30; -0.39 | — |
| SECONDARY Biomarkers by Immunochemistry |
313.9; 197.4; 291.2; 383.5; 178.2; 172.9 | — |
| SECONDARY Biomarkers by Immunochemistry: Epidermal Differentiation |
0.76; 0.89; 0.77; 0.75; 0.93; 0.89 | — |
| SECONDARY Biomarkers by Immunochemistry: Epidermal Proliferation |
554.1; 19.45; 443.3; 354.3; 20.50; 93.49 | — |
| SECONDARY Pathology and Histology by Treatment |
1.50; 0.17; 1.52; 1.53; 0.50; 0.67 | — |
| SECONDARY Pathology and Histology by Treatment: Epidermal Thickness |
254.6; 73.81; 187.5; 176.4; 68.48; 66.90 | — |
| SECONDARY Pathology and Histology by Treatment: Frequency of Neutrophil Abscesses |
0.14; 0.00; 0.15; 0.17; 0.00; 0.05 | — |
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
Data sourced from ClinicalTrials.gov (NCT00875277). 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.