A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis

Primus Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Psoriasis

Treatments: Drug: Vehicle Lotion; Drug: Comp01 Lotion; Drug: Vehicle Spray; Drug: DFD01 Spray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01947491

1205

Details and patient eligibility

About

The objectives of this study are to compare the safety of DFD01 Spray to Comp01 Lotion for topical treatment of moderate plaque psoriasis and to compare the efficacy of DFD01 Spray to Placebo Spray for topical treatment of moderate plaque psoriasis after 28 days of treatment.

Enrollment: 394 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque-type psoriasis.
• Subjects with psoriasis involving 10 to 20% BSA, not including the face, scalp, groin, axillae and other intertriginous areas.
• Subjects must have an IGA grade of 3 (moderate) at the Baseline Visit

Exclusion criteria

• Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
• Other inflammatory skin disease that may confound the evaluation of the plaque psoriasis (e.g., atopic dermatitis, contact dermatitis, tinea corporis).
• Presence of pigmentation, extensive scarring, or pigmented lesions or sunburn which could interfere with the rating of efficacy parameters.
• History of psoriasis unresponsive to topical treatments.
• History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

394 participants in 4 patient groups, including a placebo group

DFD01 Spray

Experimental group

Description:

DFD01 Spray twice daily for 28 days

Treatment:

Drug: DFD01 Spray

Vehicle Spray

Placebo Comparator group

Description:

Vehicle Spray twice daily for 28 days

Treatment:

Drug: Vehicle Spray

Comp01 Lotion

Active Comparator group

Description:

Comp01 Lotion twice daily for 14 days

Treatment:

Drug: Comp01 Lotion

Vehicle Lotion

Placebo Comparator group

Description:

Vehicle Lotion twice daily for 28 days

Treatment:

Drug: Vehicle Lotion