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Patients will receive either a gel containing both calcipotriene plus betamethasone or gel with no active ingredients as treatment for their scalp psoriasis for 8 weeks. After this time all patients will receive the gel containing both calcipotriene and betamethasone for 44 weeks. In addition, patients will receive an ointment containing both calcipotriene plus betamethasone as treatment for their psoriasis of the trunk and limbs for 52 weeks.
The objective is to study the short-term efficacy of the gel, and the short and long-term safety of the gel and the ointment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriene/betamethasone gel and ointment | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the efficacy (in terms of patients with clear or minimal disease) of 8 weeks treatment with combination (calcipotriene plus betamethasone dipropionate) gel with that of the gel vehicle in scalp psoriasis. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the safety of 8 weeks treatment with combination gel with that of the gel vehicle in scalp psoriasis. | ||
| To evaluate the efficacy and safety of 4 weeks treatment with combination ointment in psoriasis vulgaris of trunk/limbs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| S Tyring, MD | Center for Clinical Studies | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Studies | Houston | Texas | 77058 | United States |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C055085 | calcipotriene |
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| To evaluate the safety of 52 weeks treatment (used when required) with combination gel in scalp psoriasis. |
| To evaluate the safety of 52 weeks treatment (used when required) with combination ointment in psoriasis vulgaris of trunk/limbs. |