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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 14, 2020
Last Update Posted : August 17, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

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.

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Study Type : Interventional  (Clinical Trial)
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 : August 21, 2017
Actual Primary Completion Date : May 18, 2018
Actual Study Completion Date : May 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

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 Name: 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 Name: 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 Name: 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 Name: Vehicle Cream 0%




Primary Outcome Measures :
  1. Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups [ Time Frame: Baseline to Week 12 ]
    Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  3. Known allergic reaction to retinoids or tazarotene or any of the product ingredients.
  4. 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.
  5. 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.
  6. Subjects who have been treated for alcohol dependence or alcohol or drug abuse in the year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03341910


Locations
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United States, Florida
International Dermatology Inc.
Miami, Florida, United States, 33144
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Study Director: Srinivas R. Sidgiddi, M.D. Dr. Reddy's Laboratories Inc.
  Study Documents (Full-Text)

Documents provided by Dr. Reddy's Laboratories Limited:
Study Protocol  [PDF] November 6, 2017
Statistical Analysis Plan  [PDF] September 11, 2018

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03341910    
Other Study ID Numbers: DFD-03-CD-008
First Posted: November 14, 2017    Key Record Dates
Results First Posted: August 14, 2020
Last Update Posted: August 17, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tazarotene
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Nicotinic Acids
Dermatologic Agents
Keratolytic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs