DFD-01, a betamethasone dipropionate 0.05% spray, 
improved quality of life and treatment satisfaction in subjects with moderate psoriasis

Joseph Fowler, MD1; Kent Allenby, MD2; Srinivas Sidgiddi, MD2
1Dermatology Specialists Research, Louisville, KY; 2Promius Pharma, a subsidiary of Dr. Reddy’s Laboratories, Princeton, NJ

Conclusions

Financial Support: This study was funded and sponsored by the Dr. Reddy’s Laboratories group of companies DRL Publication # 786

-1.1

-0.6

-1.2

-1

-0.8

-0.6

-0.4

-0.2

0
IGA Change Baseline to Day 14

BSA 3% to 10% BSA >10%

-2.6

-2.8
-2.85
-2.8

-2.75
-2.7

-2.65
-2.6

-2.55
-2.5

TSS Change Baseline to Day 14

BSA 3% to 10% BSA > 10%

44.9

48.1

43

44

45

46

47

48

49
TSQM-II Scores at Day 14

BSA 3% to 10% BSA > 10%

-0.8

-2.5
-3

-2.5

-2

-1.5

-1

-0.5

0
% BSA Change Baseline to Day 14

BSA 3% to 10% BSA > 10%

Change in Clinical and QoL Parameters From Baseline to Day 14 (IIT Population)

1. Finlay AY, Khan GK. "The Dermatology Life Quality Index: A simple practical measure for routine clinical use". British Association of Dermatologists Annual Meeting, Oxford, July 1993. 
British Journal of Dermatology, 1993;129(Suppl 42):27.

Reference

¾ Of 45 subjects enrolled, 24 had low BSA (3%-10%) and 21 had high BSA (>10%).

¾ 14 days of twice daily DFD-01 treatment was associated with decreased mean values 
of IGA (-0.9), TSS (-2.7), and BSA (-1.5%).

¾ Mean IGA reduction was greater in the low BSA group, whereas mean TSS and BSA 
reductions were greater in the high BSA group. 

¾ DLQI decreased from a mean of 8.9 ± 6.7 at baseline to 3.3 ± 3.6 at day 14. The high 
BSA group showed greater improvement in QoL. 

¾ Mean TSQM-II score was 46.2 at day 14, with greater treatment satisfaction in the 
high BSA group (48.1 vs 44.9).

Introduction

¾ DFD-01 [Sernivo™ (betamethasone dipropionate) Spray, 0.05%] is a spray 
formulation approved for the treatment of mild to moderate plaque psoriasis in adults.

¾ The efficacy and tolerability of DFD-01 have been demonstrated in subjects with 
extensive, moderate plaque psoriasis (10% to 20% body surface area [BSA]).

¾ This study assessed quality of life (QoL) and treatment satisfaction ratings of 
subjects with moderate plaque psoriasis.

¾ DFD-01 was associated with decreased IGA, TSS, and BSA in adults with moderate plaque psoriasis. 
¾ Treatment was associated with improved QoL after 2 weeks of treatment, and subjects reported satisfaction with DFD-01 in both low (3%-10%) and high (>10%) 

BSA groups.
¾ DFD-01 treatment resulted in better outcomes in subjects with higher BSA involvement at baseline.

Methods 

¾ In this open-label, multicenter study, adults with moderate plaque psoriasis 
(IGA = 3; BSA > 3%, excluding intertriginous areas) applied DFD-01 to affected 
areas twice daily for 28 days. For each subject, investigators identified 2 target 
lesions representative of overall disease. 

¾ Assessments occurred at days 1 (baseline), 8, 14, and 29. At each visit, disease 
severity was assessed by IGA, total sign score (TSS) of target lesions, and BSA, 
and target lesions were photographed. 

¾ QoL was evaluated using the Dermatology Life Quality Index (DLQI), a 10-item 
questionnaire assessing impact of skin disease on quality of life (scores range from 
0 (best) to 30 (worst)1.

¾ Patient satisfaction was evaluated using the Treatment Satisfaction Questionnaire 
for Medication–Version II (TSQM-II),  9-items assessing effectiveness, side effects, 
convenience, and global satisfaction, yielding scores ranging from 0 (extremely 
unsatisfied) to 100 (extremely satisfied). 

¾ Primary endpoints were:

(1) Change from baseline in clinical response and QoL at day 14

(2) Treatment Satisfaction at day 14

Results 

Change in Clinical and QoL Parameters From Baseline to Day 14 (IIT Population)


	FC17PosterPromiusFowlerDFDPsoriasis.pdf