Slide 1


 The Full Analysis Set (FAS) included 200 subjects. Of these, 

53 subjects were in the DFD-29 (40 mg) group, 47 in DFD-

29 (20 mg), 48 in doxycycline (40 mg) and 52 in the placebo 

group. At week 16 the median reduction in total RosaQoL

was 11 points in DFD-29 (40 mg), 8 points in DFD-29 (20 

mg), 3 points in doxycycline (40 mg) and 1 point in the 

placebo group (Fig.1).

 Highly statistically significant treatment differences 

(p<0.0001) were demonstrated for DFD-29 (40 mg) versus 

placebo and doxycycline (40 mg), as well as for DFD-29 (20 

mg) versus Placebo. 

 The OFM study demonstrated that DFD-29 (40 mg) and oral 

doxycycline 40 mg, provide similar dermal interstitial space 

fluid (dISF) levels of minocycline and doxycycline, 

respectively.

DFD-29, a low dose oral minocycline, shows significant improvement in quality of life in subjects 

with papulopustular rosacea 

Linda Stein Gold, MD1; Joshua Zeichner, MD2 ; Shanavas Alikunju, PhD3; Anirudh Gautam, MPharm4; Srinivas Shenoy MD5; Preeti Singh, MD5;  Srinivas Sidgiddi, MD5

1Henry Ford Medical Center, Detroit, MI; 2Mount Sinai Hospital, NY; 3Dr Reddy’s Laboratories Ltd., Hyderabad, India; 4Dr Reddy’s Laboratories SA, Basel, Switzerland; 5Dr Reddy’s 

Laboratories Inc., Princeton, NJ

Introduction

 Rosacea is a chronic facial skin disease that can have an adverse effect on quality of life.

 DFD-29 a low dose oral minocycline is being evaluated as an anti-inflammatory treatment option for papulopustular rosacea. 

Conclusions

 Improvement in the quality of life is a significant unmet need in rosacea. DFD-29 has the potential to meet this unmet need, and be an important 

therapeutic tool in the physician’s armamentarium. 

Methods

Figure 1. RosaQol reduction at week 16

 This phase 2, randomized, double-blind trial enrolled adults with mild, moderate or severe papulopustular rosacea.

 Subjects were randomized to receive DFD-29 (minocycline HCl) 40 mg extended release (ER) capsules, DFD-29, 20 mg ER capsules, Oraycea® 

(doxycycline HCl) 40 mg capsules or placebo, one capsule a day for 16 weeks. 

 A key endpoint in the study was to assess change in the Quality of Life (QoL) using RosaQoL (a rosacea specific QOL tool) from baseline to week 16. 

RosaQoL has 21 general questions each rated on a 5-grade scale, and 6 global questions. A reduction in the total RosaQoL score indicates an improved 

QoL.

 In an earlier phase 1 study, the dermal Interstitial Space Fluid (dISF) levels of doxycycline (Oraycea) and minocycline (DFD-29) were measured, using 

Open-Flow Microperfusion (OFM) in healthy human subjects. 

Financial Support: This study was funded and sponsored by the Dr. Reddy’s Laboratories group of companies, Princeton, NJ, 08540, USA. DRL Publication # 884                                                                                                                          

Results

-15

-10

-5

0

DFD-29 40mg, n=53 DFD-29 20mg, n=47 Doxycycline 40mg, n=48 Placebo, n=52

-11

M
e

d
ia

n
 r

e
d

u
c
ti
o

n
 i
n

 R
o

s
a

Q
o

L

- 8

- 3

*  #

* 

-1

*Statistical significance reported vs placebo, # Statistical significance reported vs Doxycycline