Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study

Taro Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Psoriasis

Treatments: Drug: Desoximetasone 0.25% once daily; Drug: Vehicle twice daily; Drug: Vehicle once daily; Drug: Desoximetasone 0.05% once daily; Drug: Desoximetasone 0.05% twice daily

Study type: Interventional

Funder types: Industry

Identifiers

NCT01018134

DSXS 0906.00

70915004 (Other Identifier)

Details and patient eligibility

About

The objectives of this study are to evaluate the efficacy and safety of two dosing regimens of desoximetasone 0.05% and 0.25% topical sprays as compared to a vehicle spray in patients with moderate to severe plaque psoriasis.

Enrollment: 151 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a definite clinical diagnosis of stable plaque psoriasis involving ≥ 10% of the body surface area (BSA).
• Have a combined total lesion severity score (TLSS) of ≥ 7 for the target lesion.
• Have a plaque elevation score ≥ 3 of (moderate) for the target lesion.
• The target lesion must have an area of at least 5 cm².
• Have a Physicians Global Assessment (PGA) score of 3 (moderate) or 4 (severe) at baseline for the overall disease severity.

Exclusion criteria

• Pregnancy
• Current diagnosis of other types of psoriasis other than stable plaque psoriasis or has psoriasis of any kind of the face or scalp that will require active treatment during the study.
• History of psoriasis that has been unresponsive to topical corticosteroid therapy.
• Dermatological conditions that may interfere with the clinical assessments of the signs and symptoms of psoriasis.
• Allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance which would compromise the safety of the patient or the results of the study.
• Any condition that would place the study patient at undue risk by participation in the study.
• Radiation therapy, antineoplastic agents or immunosuppressant medication within 4 weeks prior to the first dose of study drug.
• Treatment with any systemic or photo antipsoriatic therapy, within 8 weeks of the first dose of study drug.
• Treatment within 12 weeks (or five half lives, whichever is less) prior to the first dose of study drug with any biological therapies for psoriasis.
• Systemic steroids within 4 weeks of the first dose of the study drug. The use of inhaled or intranasal corticosteroids is acceptable as long as usage has been stable for at least 2 weeks prior to the first dose of study drug and will be continued during the study.
• Hormonal contraceptives for less than one complete cycle prior to entering the study.
• Topical antipsoriatic agents of any kind or any topical corticosteroids for any reason within 2 weeks prior to first use of study drug. Nonprescription antipsoriatic shampoos used only on the scalp will be allowed during the study.
• Receipt of any drug as part of a research study within 30 days prior to first dosing.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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151 participants in 6 patient groups, including a placebo group

Desoximetasone 0.05% once daily

Experimental group

Description:

Desoximetasone topical spray 0.05% administered once daily to affected area

Treatment:

Drug: Desoximetasone 0.05% once daily

Desoximetasone 0.05% twice daily

Experimental group

Description:

Desoximetasone topical spray 0.05% administered twice daily to affected area

Treatment:

Drug: Desoximetasone 0.05% twice daily

Desoximetasone 0.25% once daily

Experimental group

Description:

Desoximetasone topical spray 0.25% administered once daily to affected area

Treatment:

Drug: Desoximetasone 0.25% once daily

Drug: Desoximetasone 0.25% once daily

Desoximetasone 0.25% twice daily

Experimental group

Description:

Desoximetasone topical spray 0.25% administered twice daily to affected area

Treatment:

Drug: Desoximetasone 0.25% once daily

Drug: Desoximetasone 0.25% once daily

Vehicle once daily

Placebo Comparator group

Description:

Vehicle administered to affected areas once daily

Treatment:

Drug: Vehicle once daily

Vehicle twice daily

Placebo Comparator group

Description:

Vehicle administered to affected areas twice daily

Treatment:

Drug: Vehicle twice daily