Phase 3
Completed N=394
A Comparison of DFD01 Spray Versus Comp01 Lotion, Vehicle Spray and Vehicle Lotion in Subjects With Moderate Psoriasis
Source: ClinicalTrials.gov NCT01947491 ↗Enrolled (actual)
394
Serious AEs
0.8%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants With Success According to the Investigator Global Assessment (IGA) — 19.0; 2.3 percentage of patients — p=<0.001
◆ Published Evidence
Emerging
4citations · ~1 / year
Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis.
Summary
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.
Linked Publications
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Efficacy, Safety, and Potency of Betamethasone Dipropionate Spray 0.05%: A Treatment for Adults with Mild-to-moderate Plaque Psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Success According to the Investigator Global Assessment (IGA) |
19.0; 2.3 | <0.001 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01947491) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.