1404003_OpenPsori.PlaqueTest to Eval.Eff.of Diff.Comp. to Mapracorat
Keywords
Abstract
Dates
| Last Verified: | 11/30/2017 |
| First Submitted: | 01/08/2018 |
| Estimated Enrollment Submitted: | 01/08/2018 |
| First Posted: | 01/15/2018 |
| Last Update Submitted: | 01/08/2018 |
| Last Update Posted: | 01/15/2018 |
| Actual Study Start Date: | 02/10/2013 |
| Estimated Primary Completion Date: | 05/30/2013 |
| Estimated Study Completion Date: | 05/30/2013 |
Condition or disease
Intervention/treatment
Drug: Mapracorat
Drug: Prednicarbate
Drug: Clobetasol
Drug: Calcipotriene
Drug: Calcipotriene/Betamethasone dipropionate
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Mapracorat 10 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of mapracorat was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 | Drug: Mapracorat 0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment |
| Active Comparator: Prednicarbate 10 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of prednicarbate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 | Drug: Prednicarbate 0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment |
| Active Comparator: Clobetasol 10 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of clobetasol was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 | Drug: Clobetasol 0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment |
| Active Comparator: Calcipotriene 10 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of calcipotriene was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 | Drug: Calcipotriene 0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment |
| Active Comparator: Calcipotriene/Betamethasone dipropionate 10 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the corresponding test fields (3 cm2) of the affected skin plaques (15 cm2 were treated in total [diameter 2 cm, distance to next test field at least 2 cm]). 200 µL of calcipotriene/betamethasone dipropionate was applied on 6 days a week for up to 4 weeks onto the defined test fields (12.5 cm2 were treated in total [diameter 1.8 cm, distance to next test field at least 1.5 cm]) occluded with Finn chambers of the non-lesional skin areas of 2.5 cm2 | Drug: Calcipotriene/Betamethasone dipropionate 0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | Inclusion Criteria: - Male or female subjects 18 to 65 years of age with stable plaque-type psoriasis, plaques of adequate size to allow for evaluation of 5 test fields, on comparable body area; thickness of the echo-lucent band under the entry echo as assessed by ultrasound of at least 200 μm Exclusion Criteria: - Positive testing in urine drug screening - Pregnancy or lactation - A history of relevant diseases, especially-incompletely cured pre-existing diseases for which it could have been assumed that the absorption, distribution, excretion and effect of the study drugs would not be normal - Volunteers with severe kidney or liver disease - Volunteers with concurrent/acute viral infections in the test field areas (e.g. herpes simplex, varicella) or other specific skin alterations (skin tuberculosis, syphilitic skin lesions) - Severe disease within the last 4 weeks prior to the first study drug administration - Volunteers with known hypersensitivity reaction when applying adhesive bandages - Volunteers who were treated with any systemic therapy for psoriasis (e.g. methotrexate, cyclosporin A, etretinate, acitretin, PUVA, fumaric acid) three months prior to screening - Volunteers who were treated with any systemic corticosteroids (oral, intramuscular, high-dose inhaled, rectal) 4 weeks prior to screening - Volunteers who were treated with any local therapy for psoriasis (e.g. corticosteroids, calcitriol analogues, dithranol, phototherapy) 2 weeks prior to screening - Target plaques localized on head and neck, elbows and knees, palms and soles, nails and folds or other mechanically strained sites - Volunteers with guttate or pustular psoriasis - Volunteers with spontaneously improving or rapidly deteriorating plaque-type psoriasis - Volunteers with erythrodermic type of psoriasis - Volunteers with severe recalcitrant psoriasis requiring additional therapy - Presence of hepatitis B virus surface antigen, hepatitis C virus antibodies or human immune deficiency virus antibodies - Clinico-chemical parameters of clinically significant deviation - Volunteers with a known allergy to any of the excipients of the trial medication |
Outcome
Primary Outcome Measures
1. Baseline-corrected area under the curve of the psoriatic infiltrate thickness (PIT) measured by 20 MHz B mode ultrasound [Prior to drug application from Day 1 and up to Day 29]
Secondary Outcome Measures
1. Skin thickness measurement of occluded test field on non-lesional skin (mean of triplicate measurement) [Prior to drug application from Day 1 up to Day 60]
2. Clinical assessment of atrophy using a 5-point score [Prior to drug application from Day 1 and up to Day 29]
3. Clinical assessment of telangiectasia using a 5-point score [Prior to drug application from Day 1 and up to Day 29]
4. Clinical assessment of local tolerability using a 5-point score [Prior to drug application from Day 1 and up to Day 29]
5. PIT measured by 20 MHz B mode ultrasound [Prior to drug application from Day 1 and up to Day 29]
6. Measurement of erythema using chromametry (mean of triplicate measurement) [Prior to drug application from Day 1 and up to Day 29]
7. Clinical efficacy assessment of the skin in the test fields using a 5-point score [Prior to drug application from Day 1 and up to Day 29]
8. Number of participants with adverse events [Approximately 64-84 days]
