An Open-Label, Multicenter Study of Patient-Reported Satisfaction Following Twice Daily Dosing With Betamethasone Dipropionate Spray, 0.05% in Subjects With Moderate Plaque Psoriasis

NCT02749799 Phase 4 COMPLETED Results posted

The purpose of this study is to assess clinical response and patient satisfaction when DFD-01 is used topically twice a day for moderate plaque psoriasis.

Details

Lead sponsor	Primus Pharmaceuticals
Phase	Phase 4
Status	COMPLETED
Enrolment	45
Start date	2016-02
Completion	2016-08

Conditions

• Plaque Psoriasis

Interventions

• DFD-01 (betamethasone dipropionate) Spray, 0.05%

Primary outcomes

• Change in Investigator's Global Assessment Grade — Change from Baseline to Day 14.
  The mean change in the IGA score from baseline to Day 14 was assessed. IGA score is a static assessment of disease severity and is based on overall severity of signs at each visit. It's a 4-point scale where '0' is absent disease and '4' is 'Severe/Very Severe' disease. A lower score at the end of the study compared to baseline (negative change), indicates an improvement in the disease condition.
• Change in Percent Body Surface Area (BSA) Involved. — Change from Baseline to Day 14.
  Change in the BSA of involvement with psoriasis from baseline to Day 14 was assessed. BSA was assessed at Baseline, Days 8, 14 and 29.
• Change in Dermatology Life Quality Index (DLQI) — Change from Baseline to Day 14.
  DLQI is a simple, compact, and practical questionnaire to assess limitations related to the impact of skin disease. The instrument contains ten items dealing with the participant's skin. The participant responds on a four-point scale, ranging from "Very Much" (score 3) to "Not at All" or "Not relevant" (score 0). The DLQI total score is derived by summing all item scores, which has a possible range of 0 to 30, with 30 corresponding to the worst quality of life, and 0 corresponding to the best. A lower score (i.e., negative change score) indicates improvement in the Quality of Life.

Countries

United States