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A Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® Cream, 0.1% in the Topical Treatment of Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03341910
Recruitment Status : Completed
First Posted : November 14, 2017
Results First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: DFD-03 Lotion, 0.1%
Drug: Tazorac Cream, 0.1%
Drug: DFD-03 Vehicle Lotion 0%
Drug: Tazorac Vehicle Cream 0%
Enrollment 155
Recruitment Details  
Pre-assignment Details  
Arm/Group Title DFD-03 Lotion, 0.1% Tazorac Cream, 0.1% DFD-03 Vehicle Lotion Tazorac Vehicle Cream
Hide Arm/Group Description

DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off

DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours

Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Vehicle Lotion to be applied twice daily for 1 minute and rinsed off

DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours

Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Period Title: Overall Study
Started 54 49 26 26
Completed 54 49 26 26
Not Completed 0 0 0 0
Arm/Group Title DFD-03 Lotion, 0.1% Tazorac Cream, 0.1% DFD-03 Vehicle Lotion Tazorac Vehicle Cream Total
Hide Arm/Group Description

DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off

DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours

Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Vehicle Lotion to be applied twice daily for 1 minute and rinsed off

DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours

Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Total of all reporting groups
Overall Number of Baseline Participants 54 49 26 26 155
Hide Baseline Analysis Population Description
Safety Population - All subjects who received study product and provided any post-baseline safety information.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 49 participants 26 participants 26 participants 155 participants
<=18 years
20
  37.0%
13
  26.5%
10
  38.5%
9
  34.6%
52
  33.5%
Between 18 and 65 years
34
  63.0%
36
  73.5%
16
  61.5%
17
  65.4%
103
  66.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 54 participants 49 participants 26 participants 26 participants 155 participants
21.9  (9.5) 23.1  (8.9) 22.0  (9.7) 25.0  (10.5) 22.8  (9.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 49 participants 26 participants 26 participants 155 participants
Female
25
  46.3%
27
  55.1%
12
  46.2%
12
  46.2%
76
  49.0%
Male
29
  53.7%
22
  44.9%
14
  53.8%
14
  53.8%
79
  51.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 49 participants 26 participants 26 participants 155 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   7.4%
0
   0.0%
2
   7.7%
1
   3.8%
7
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   3.8%
0
   0.0%
1
   0.6%
Black or African American
4
   7.4%
5
  10.2%
3
  11.5%
6
  23.1%
18
  11.6%
White
46
  85.2%
44
  89.8%
20
  76.9%
18
  69.2%
128
  82.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.8%
1
   0.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 54 participants 49 participants 26 participants 26 participants 155 participants
54 49 26 26 155
1.Primary Outcome
Title Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups
Hide Description Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.
Time Frame Baseline to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population - All subjects who received study product and provided any post baseline safety information.
Arm/Group Title DFD-03 Lotion, 0.1% Tazorac Cream, 0.1% DFD-03 Vehicle Lotion Tazorac Vehicle Cream
Hide Arm/Group Description:

DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off

DFD-03 Lotion, 0.1%: DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours

Tazorac Cream, 0.1%: Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Vehicle Lotion to be applied twice daily for 1 minute and rinsed off

DFD-03 Vehicle Lotion 0%: Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours

Tazorac Vehicle Cream 0%: Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Overall Number of Participants Analyzed 54 49 26 26
Measure Type: Number
Unit of Measure: Adverse Events
73 81 14 15
Time Frame Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
Adverse Event Reporting Description Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks). Spontaneously reported SAEs, which were reported up to 30 days after discontinuing study product use (approximately 4 months).
 
Arm/Group Title DFD-03 Lotion, 0.1% Tazorac Cream, 0.1% Vehicle Lotion Vehicle Cream
Hide Arm/Group Description

DFD-03 Lotion, 0.1% was applied twice daily approximately 12 hours apart, for 1 minute and rinsed off

DFD-03 Lotion, 0.1%: DFD-03 Lotion was applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Tazorac Cream, 0.1% was applied once in the evening and left overnight for approximately 12 hours

Tazorac Cream, 0.1%: Tazorac Cream was applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

Vehicle Lotion was applied twice daily for 1 minute and rinsed off

DFD-03 Vehicle Lotion 0%: Vehicle Lotion was applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.

Vehicle Cream was applied once in the evening and left overnight for approximately 12 hours

Tazorac Vehicle Cream 0%: Vehicle Cream was applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.

All-Cause Mortality
DFD-03 Lotion, 0.1% Tazorac Cream, 0.1% Vehicle Lotion Vehicle Cream
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)      0/49 (0.00%)      0/26 (0.00%)      0/26 (0.00%)    
Hide Serious Adverse Events
DFD-03 Lotion, 0.1% Tazorac Cream, 0.1% Vehicle Lotion Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/54 (0.00%)      0/49 (0.00%)      0/26 (0.00%)      0/26 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
DFD-03 Lotion, 0.1% Tazorac Cream, 0.1% Vehicle Lotion Vehicle Cream
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/54 (40.74%)      26/49 (53.06%)      9/26 (34.62%)      11/26 (42.31%)    
General disorders         
Application site dryness  1  18/54 (33.33%)  18 17/49 (34.69%)  17 2/26 (7.69%)  2 3/26 (11.54%)  3
Application site exfoliation  1  14/54 (25.93%)  14 12/49 (24.49%)  12 2/26 (7.69%)  2 3/26 (11.54%)  3
Application Site Pain  1  14/54 (25.93%)  14 13/49 (26.53%)  13 1/26 (3.85%)  1 1/26 (3.85%)  1
Application Site Erythema  1  8/54 (14.81%)  8 9/49 (18.37%)  9 1/26 (3.85%)  1 3/26 (11.54%)  3
Application Site Pruritus  1  6/54 (11.11%)  6 3/49 (6.12%)  3 2/26 (7.69%)  2 2/26 (7.69%)  2
Infections and infestations         
Viral upper respiratory tract infection  1  1/54 (1.85%)  1 5/49 (10.20%)  5 2/26 (7.69%)  2 1/26 (3.85%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Srinivas Sidgiddi, Sr. Director, Clinical Development
Organization: Dr. Reddy's Laboratories, Inc
Phone: 609-375-9910
EMail: srinivassidgiddi@drreddys.com
Layout table for additonal information
Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03341910    
Other Study ID Numbers: DFD-03-CD-008
First Submitted: October 13, 2017
First Posted: November 14, 2017
Results First Submitted: July 30, 2020
Results First Posted: August 17, 2020
Last Update Posted: August 17, 2020