DFD-01, a Novel Medium Potency Betamethasone Dipropionate 0.05% Emollient Spray, Demonstrates Similar Efficacy to Augmented Betamethasone Dipropionate 0.05% Lotion for the Treatment of Moderate Plaque Psoriasis
February 2016 | Volume 15 | Issue 2 | Original Article | 154 | Copyright © February 2016
Joseph F. Fowler Jr. MD,a Adelaide A. Hebert MD,b Jeffrey Sugarman MD PhDc
aUniversity of Louisville, Louisville, KY
bUniversity of Texas Medical School-Houston, Houston, TX
cRedwood Dermatology Research, Santa Rosa, CA
Abstract
BACKGROUND: A novel 0.05% betamethasone dipropionate emollient spray (DFD-01) was formulated to optimize penetration of steroid to the epidermal layers affected by psoriasis.
OBJECTIVE: To compare the efficacy and safety of medium potency DFD-01 with super potent augmented betamethasone dipropionate 0.05% lotion (Diprolene) for the topical treatment of moderate plaque psoriasis.
METHODS: Adults with moderate plaque psoriasis (Investigator Global Assessment [IGA]=3; 10–20% BSA) were randomized 2:1:1 to DFD-01, Diprolene, or Vehicle. Products were applied twice daily to affected areas for 14 days. Treatment success was defined as IGA=0 or 1 and ≥2-grade improvement from baseline. IGA and target lesion Total Sign Score (TSS; sum of erythema, scaling, and plaque elevation scores) were assessed at baseline and at days 4, 8, and 15. Adverse events (AEs) were recorded.
RESULTS: 351 subjects with moderate psoriasis were randomized to DFD-01 (n=174), Diprolene (n=90), or Vehicle (n=87). Mean BSA was 13–14%. Treatment success was achieved in 19.0% DFD-01, 18.9% Diprolene, and 2.3% Vehicle (
P<0.001 DFD-01 vs Vehicle) at day 15. Treatment success at day 8 was 10% DFD-01, 6.7% Diprolene, and 1.2% Vehicle (
P=0.003 DFD-01 vs Vehicle). TSS was significantly reduced with DFD-01 compared with Vehicle at days 4, 8, and 15 (
P≤0.006) and compared with Diprolene at day 4 (
P=0.010). DFD-01 relieved signs of erythema and scaling earlier than Diprolene or Vehicle, showing significant improvements on day 4 (
P≤0.048). All products were well tolerated. Significantly more burning/stinging was reported with Diprolene than DFD-01 (13.6% vs 4.1%,
P=0.006).
CONCLUSION: Medium potency DFD-01 was efficacious for the treatment of moderate psoriasis. DFD-01 demonstrated similar efficacy to super potent Diprolene lotion. Results at 4 and 8 days indicate that DFD-01 shows early improvement in some subjects. DFD-01 was well tolerated and had an excellent safety profile.
J Drugs Dermatol. 2016;15(2):154-162.
INTRODUCTION
Psoriasis is a common, chronic, inflammatory skin condition
affecting approximately 2% of the United States adult population.1,2 It is estimated that around 80% of psoriasis patients have mild to moderate disease.2 The standard
treatment for these patients is topical steroids to target skin inflammation and pathology. In addition, the vast majority of patients with severe disease requiring biologic therapy will still use topical steroids as adjunctive therapy. Therefore, it is important to use topical therapy that is safe and effective in all those affected by psoriasis, regardless of severity.
The use of steroids for the treatment of psoriasis has been long established. Oral corticosteroids were first used to treat psoriasis in the 1950s.3,4 Topical steroids were introduced in the 1960s:5 initially triamcinolone, followed by betamethasone, dexamethasone, fluocinolone, and many others.6
Betamethasone dipropionate was first investigated for the topical treatment of psoriasis in 1974.7 Studies indicate it was effective for improving the signs of psoriasis.8–10 An augmented
formulation of betamethasone dipropionate 0.05% was approved for the treatment of corticosteroid-responsive dermatoses
in 1988 under the brand name, Diprolene.11 Diprolene is classified as a super potent (Class 1) steroid and as such, has the potential to cause hypothalamic–pituitary–adrenal (HPA) axis suppression.9,12–14 Consequently, its labeling directs use to be limited to 2 consecutive weeks.11
A novel 0.05% betamethasone dipropionate emollient spray (DFD-01) formulation has recently been developed for the treatment
of psoriasis. DFD-01’s vehicle ingredients were selected from several variations to optimize penetration of the steroid to the affected layers of the epidermis, while reducing permeation
