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

• Sponsor: Dr. Reddy's Laboratories Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03341910
• Collaborator: (none)
• Enrollment: 155
• Location: 1
• Arms: 4
• Actual Duration (Months): 8.9
• Patients Per Site Per Month: 17.5

Study Details

Study Description

Brief Summary

A study for Subjects with mild to moderate facial acne vulgaris. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: DFD-03 Lotion, 0.1%; Drug: Tazorac Cream, 0.1%; Drug: DFD-03 Vehicle Lotion 0%; Drug: Tazorac Vehicle Cream 0%	Phase 2

Detailed Description

A study for Subjects with mild to moderate facial acne vulgaris. Subjects will be randomized to treatment with either DFD-03 (tazarotene) Lotion 0.1%, Tazorac (tazarotene) Cream, 0.1%, Vehicle Lotion or Vehicle Cream. During the 12-week treatment period subjects randomized to DFD-03 Lotion or Vehicle Lotion will use the study drug twice daily. Subjects randomized to Tazorac Cream or Vehicle Cream will use the study drug once daily in the evening. Subjects will be instructed to treat the entire face.

Safety assessments will include the investigator's assessment of local cutaneous tolerance/application site reactions on the face, vital signs and adverse events. Urine pregnancy tests will be performed for all female subjects. A physical examination will be performed.

Study Design

• Study Type: Interventional
• Actual Enrollment: 155 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Active-Controlled Study to Assess the Safety and Local Tolerability of DFD-03 (Tazarotene) Lotion, 0.1% Compared to Tazorac® (Tazarotene) Cream, 0.1% in the Topical Treatment of Acne Vulgaris for 12 Weeks
• Actual Study Start Date: Aug 21, 2017
• Actual Primary Completion Date: May 18, 2018
• Actual Study Completion Date: May 18, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DFD-03 Lotion, 0.1% DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off	Drug: 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.; Other Names: Tazarotene Lotion, 0.1%
Active Comparator: Tazorac Cream, 0.1% Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours	Drug: 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.; Other Names: Tazarotene Cream, 0.1%
Placebo Comparator: Vehicle Lotion Vehicle Lotion to be applied twice daily for 1 minute and rinsed off	Drug: 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.; Other Names: Vehicle Lotion 0%
Placebo Comparator: Vehicle Cream Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours	Drug: 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.; Other Names: Vehicle Cream 0%

Outcome Measures

Primary Outcome Measures

1. Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups [Baseline to Week 12]

   Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject must be at least 12 years of age. At selected site(s), a total of approximately eight subjects 9-11 years of age will be enrolled into the 2 arms of DFD-03 lotion group (active and vehicle).

2. A clinical diagnosis of facial acne vulgaris with a facial Investigator's Global Assessment (IGA) score of 2 (mild) to 3 (moderate) at Baseline. At selected site(s), up to twelve subjects with acne lesions on the chest and/or back (including shoulders) in addition to those on the face will treat their chest and/or back (including shoulders) in addition to their face.

3. Inflammatory lesion count (papules and pustules) of at least 20, non-inflammatory lesion count (closed and open comedones) of at least 25 on the face including the nose, and no more than 2 nodulocystic lesions. This criteria is not applicable to the 9-11 years age group as long as subjects have an IGA score of 2 (mild) to 3 (moderate) at Baseline.

4. Females, regardless of childbearing potential: Must have a negative urine pregnancy test and if sexually active, must be on or use an acceptable method of birth control.

5. Subjects agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash, and make-up as instructed by the investigator.

6. Subjects must be willing to comply with sun avoidance measures for the face, including use of investigator-approved sunscreen and/or hats, have limited sun exposure time, and have no tanning bed use.

7. Subject must be in good general health as determined by the investigator and supported by the medical history, physical examination and vital signs.

Exclusion Criteria:

1. Females who are pregnant or lactating or planning to become pregnant during the study period.

2. Treatment with the following products:

Topical acne treatments or other topical facial medication in the 14 days prior to Baseline Systemic corticosteroids and systemic acne treatments in the 30 days prior to Baseline Systemic retinoid use in the 180 days prior to Baseline Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in 30 days prior to Baseline.

Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.

Treatment with an investigational product or device in 30 days prior to Baseline.

1. Known allergic reaction to retinoids or tazarotene or any of the product ingredients.

2. Presence of any facial skin disease or condition that would interfere with the study or place the subject at unacceptable risk including sunburn, rosacea, seborrheic dermatitis, perioral dermatitis, lupus, dermatomyositis, psoriasis, eczema, squamous cell carcinoma, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, bacterial folliculitis or any other facial disease or condition.

3. Subjects with a serious and or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.

4. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	International Dermatology Inc.	Miami	Florida	United States	33144

Sponsors and Collaborators

• Dr. Reddy's Laboratories Limited

Investigators

• Study Director: Srinivas R. Sidgiddi, M.D., Dr. Reddy's Laboratories Inc.

Study Documents (Full-Text)

• Study Protocol - Nov 6, 2017
• Statistical Analysis Plan - Sep 11, 2018

More Information

Publications

None provided.

• Responsible Party: Dr. Reddy's Laboratories Limited
• ClinicalTrials.gov Identifier: NCT03341910
• Other Study ID Numbers: DFD-03-CD-008
• First Posted: Nov 14, 2017
• Last Update Posted: Aug 17, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Acne Vulgaris; Nicotinic Acids; Tazarotene

Study Results

Participant Flow

Arm/Group Title	DFD-03 Lotion, 0.1%	Tazorac Cream, 0.1%	DFD-03 Vehicle Lotion	Tazorac Vehicle Cream
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

Baseline Characteristics

Arm/Group Title	DFD-03 Lotion, 0.1%	Tazorac Cream, 0.1%	DFD-03 Vehicle Lotion	Tazorac Vehicle Cream	Total
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 Participants	54	49	26	26	155
Age (Count of Participants)
<=18 years	20 37%	13 26.5%	10 38.5%	9 34.6%	52 33.5%
Between 18 and 65 years	34 63%	36 73.5%	16 61.5%	17 65.4%	103 66.5%
>=65 years	0 0%	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	21.9 (9.5)	23.1 (8.9)	22.0 (9.7)	25.0 (10.5)	22.8 (9.5)
Sex: Female, Male (Count of Participants)
Female	25 46.3%	27 55.1%	12 46.2%	12 46.2%	76 49%
Male	29 53.7%	22 44.9%	14 53.8%	14 53.8%	79 51%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	4 7.4%	0 0%	2 7.7%	1 3.8%	7 4.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	1 3.8%	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%
Unknown or Not Reported	0 0%	0 0%	0 0%	1 3.8%	1 0.6%
Region of Enrollment (participants) [Number]
United States	54 100%	49 100%	26 100%	26 100%	155 100%

Outcome Measures

1. Primary Outcome

Title	Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups
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

Outcome Measure Data

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
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.
Measure Participants	54	49	26	26
Number [Adverse Events]	73	81	14	15

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/54 (0%)		0/49 (0%)		0/26 (0%)		0/26 (0%)
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%)		0/49 (0%)		0/26 (0%)		0/26 (0%)
Other (Not Including 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	22/54 (40.7%)		26/49 (53.1%)		9/26 (34.6%)		11/26 (42.3%)
General disorders
Application site dryness	18/54 (33.3%)	18	17/49 (34.7%)	17	2/26 (7.7%)	2	3/26 (11.5%)	3
Application site exfoliation	14/54 (25.9%)	14	12/49 (24.5%)	12	2/26 (7.7%)	2	3/26 (11.5%)	3
Application Site Pain	14/54 (25.9%)	14	13/49 (26.5%)	13	1/26 (3.8%)	1	1/26 (3.8%)	1
Application Site Erythema	8/54 (14.8%)	8	9/49 (18.4%)	9	1/26 (3.8%)	1	3/26 (11.5%)	3
Application Site Pruritus	6/54 (11.1%)	6	3/49 (6.1%)	3	2/26 (7.7%)	2	2/26 (7.7%)	2
Infections and infestations
Viral upper respiratory tract infection	1/54 (1.9%)	1	5/49 (10.2%)	5	2/26 (7.7%)	2	1/26 (3.8%)	1

Limitations/Caveats

[Not Specified]

More Information

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.