¾ Tazarotenic acid plasma concentrations were more than two times higher after twice daily 1-minute contact 
than after once daily 1-minute contact (Table 1).  

¾ Tazarotenic acid exposure (AUC0-24) after multiple twice daily, 1-minute applications of DFD-03, was 83.21% of 
exposure following multiple once daily, 12-hour applications of Tazorac cream (Table 1). 

¾ The Cmax after multiple twice daily applications of DFD-03 was 62.99% of the Cmax of multiple once daily 
applications of Tazorac cream (Table 1).  

¾ Erythema was the most common AE in this study, reported by nine subjects (64%) following twice daily 
1-minute application of DFD-03, five subjects (33%) following once daily, 12-hour application of Tazorac cream, 
and no subjects following once daily 1-minute application of DFD-03 (Table 2).

DFD-03 (0.1% tazarotene), twice-daily, short-contact lotion formulation, showed similar pharmacokinetic 
exposure (AUC0-24) to the marketed cream product Tazorac® (tazarotene) with once daily overnight application

Srinivas Sidgiddi, MD1; Usha Ranganathan, MD1; Anirudh Gautam, MPharm2
1Promius Pharma, a subsidiary of Dr. Reddy’s Laboratories, Princeton, NJ, USA 2Dr. Reddy’s Laboratories SA., Basel, Switzerland

Conclusions

¾ The parameters AUC0-24 and Cmax of DFD-03 lotion were significantly impacted by frequency of dosing. Systemic exposure to tazarotenic acid appeared to be dependent on the duration of dosing for all 
treatments. 

¾ DFD-03, lotion formulation applied twice daily for 1-minute showed similar pharmacokinetic exposure (AUC0-24) to Tazorac cream with once daily overnight application.

Methods 

Table 1. Summary of the Statistical Analysis of Tazarotenic Acid – Day 14

¾ This was a single center, randomized, multiple dose, laboratory-blinded, open-label, 3-arm, parallel design 
study with 16 healthy subjects in each arm.  

¾ In each treatment group, approximately 5 g of test product was applied to the face, neck, shoulders, upper 
chest and upper back (approximately 15% body surface area) on days 1 through 14. 

¾ In treatment group 1, DFD-03 lotion was applied twice daily, 12 hours apart, and rinsed off after 1-minute 
contact.  

¾ In treatment group 2, DFD-03 lotion was applied once daily and rinsed off after 1-minute contact. 
¾ In treatment group 3, Tazorac cream was applied once daily and rinsed off after 12-hours contact. 
¾ Blood samples were collected on days 1, 7 and 14, prior to product application and for up to 24 hours after 

product application.

Financial Support: This study was funded and sponsored by the Dr. Reddy’s Laboratories group of companies DRL Publication #815

Results

Introduction

¾ The American Academy of Dermatology states that retinoids are the core of topical therapy for acne.
¾ Common side effects include erythema, peeling, and dryness. 
¾ Results of a phase 1 bioavailability study comparing DFD-03 (tazarotene 0.1%) lotion twice daily (1-minute 

application), DFD-03 lotion once daily (1-minute application), and Tazorac cream once daily (overnight 
application), are presented here.

Parameter CV (%)

Geometric LS Means
Comparison Ratio (%)

90% Confidence Limits
(%)Treatment 

Group 1
Treatment 
Group 2

Treatment 
Group 3 Lower Upper

Cmax

54.7 164.20 77.72 260.66 1 vs 2 211.26 151.58 294.45

54.7 164.20 77.72 260.66 1 vs 3 62.99 45.48 87.26

54.7 164.20 77.72 260.66 2 vs 3 29.82 21.39 41.56

AUC0-24

53.6 3797.48 1492.58 4563.57 1 vs 2 254.42 199.60 324.31

18.9 3797.48 1492.58 4563.57 1 vs 3 83.21 57.63 120.15

71.4 3797.48 1492.58 4563.57 2 vs 3 32.71 24.18 44.24

System Organ Class
MedDRA Preferred Term

Treatment Group 1 
(N=14); n (%)

Treatment Group 2 
(N=14); n (%)

Treatment Group 3 
(N=14); n (%)

Subjects with at least 1 AE 10 (71) 4 (29) 6 (40)
Skin And Subcutaneous Tissue Disorders 10 (71) 3 (21) 5 (33)

Erythema 9 (64) 0 5 (33)
Dry Skin 0 3 (21) 0 
Skin Burning Sensation 2 (14) 1 (7) 0
Pruritus 1 (7) 1 (7) 0
Rash 1 (7) 0 0
Skin Discomfort 1 (7) 0 0
Skin Irritation 0 0 1 (7) 

Nervous System Disorders 2 (14) 1 (7) 2 (13)
Burning Sensation 1 (7) 0 1 (7)
Dizziness 1 (7) 1 (7) 0
Hyperaesthesia 1 (7) 0 1 (7)

Musculoskeletal And Connective Tissue Disorders 0 0 1 (7)
Arthralgia 0 0 1 (7)

Respiratory, Thoracic, And Mediastinal Disorders 1 (7) 0 0
Nasal Discomfort 1 (7) 0 0

Table 2. Summary of Adverse Events by System Organ Class


	FC17PosterPromiusSidgiddiDFDOvernightApplication.pdf