¾ 356 subjects were randomized to DFD-01, 90 subjects to AugBD, and 182 subjects to Vehicle. 

¾ Individual sign scores all showed improvement with treatment, and DFD-01 showed significantly greater 
effect than AugBD at day 4 for erythema (23.6% vs 12.2%, P=.021) and scaling (39.6% vs 25.6%, 
P=.014) (Figure 1).

¾ Reduction in TSS was greater with DFD-01 than with AugBD at day 4 (-17.3% vs -10.6%, P=.009) 
(Figure 2). 

¾ At day 4 DFD-01  was also significantly different from AugBD for both TSS50 (13.2% vs 5.6%, P=.044) 
and TSS≤1 for any sign (13.8% vs 5.6%, P=.031). 

DFD-01, a VCA midpotent betamethasone dipropionate 0.05% emollient-like spray formulation, 
demonstrates earlier onset of action compared with a super potent topical steroid for the treatment of moderate psoriasis 

Leon Kircik, MD1; Jonathan S. Weiss, MD2; Kent Allenby, MD3
1DermResearch, PLLC, Louisville, KY; 2Gwinnett Dermatology, Snellville, GA; 3Promius Pharma, a subsidiary of Dr. Reddy’s Laboratories, Princeton, NJ

Introduction

¾ Typically, topical steroids that are considered super potent by vasoconstrictor assay (VCA) have 
demonstrated the highest efficacy along with a higher potential for HPA axis suppression.

¾ DFD-01, a VCA midpotent topical steroid, [Sernivo™ (betamethasone dipropionate) Spray, 0.05%], 
approved for the treatment of mild to moderate plaque psoriasis in adults, was formulated to achieve a 
balance of steroid penetration to and persistence within the dermis and epidermis while minimizing 
absorption into the systemic circulation.

¾ DFD-01, an emollient-like spray formulation was compared with a super potent augmented 
betamethasone dipropionate 0.05% steroid lotion (AugBD) for the treatment of moderate plaque 
psoriasis. 

¾ Early response to treatment is the focus of this post hoc analysis

Conclusions

¾ Midpotent DFD-01 (betamethasone dipropionate 0.05% spray) showed efficacy on global measures 
of IGA, TSS and TSS50 with significant improvement at day 4 on all outcomes compared to baseline

¾ At day 4 TSS improvement was greater with DFD-01 compared with super potent augmented 
betamethasone dipropionate 0.05% lotion.

Methods 

Figure 1. Pooled Analysis of Early Onset of Relief of Erythema and Scaling 

¾ Data from two phase 3, randomized, clinical trials enrolling adults with moderate plaque psoriasis 
(IGA=3; 10% to 20% BSA) were pooled. 

¾ Subjects were randomized to receive DFD-01, AugBD, or Vehicle Spray (Vehicle) and products were 
applied to all affected areas on the body excluding face, scalp, and intertriginous areas twice daily for 14 
or 29 days. DFD-01 was applied for 29 days and AugBD was applied for 14 days per their respective 
labels. 

¾ Treatment success at days 4 and 8 was defined as IGA=0 or 1 and ≥2 grade improvement from baseline. 
¾ Reduction in total sign score (TSS) for a target lesion (the sum of erythema, plaque and elevation 

scores), individual sign scores, TSS50 and TSS≤1 for any sign, were also assessed. Analysis was by 
Fisher’s exact test.

Financial Support: This study was funded by the Dr. Reddy’s Laboratories group of companies. DRL Publication #   794                                                                                                          

Results 

Figure 2. Pooled Analysis Reduction  in TSS  


	FC17PosterPromiusKircikDFDEarlyOnset.pdf