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A 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

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ClinicalTrials.gov Identifier: NCT03341910
Recruitment Status : Completed
First Posted : November 14, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Tracking Information
First Submitted Date  ICMJE October 13, 2017
First Posted Date  ICMJE November 14, 2017
Last Update Posted Date October 8, 2019
Actual Study Start Date  ICMJE August 21, 2017
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03341910 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • IGA Success [ Time Frame: Baseline to Week 12 ]
    Proportion of subjects with IGA success defined as an IGA score of 0 or 1 at the end of the study with at least 2 grades reduction from Baseline
  • Lesion Count Reduction [ Time Frame: Baseline to Week 12 ]
    Absolute change in inflammatory and non-inflammatory lesion counts at Week 12 compared to Baseline
  • Cardiff Acne Disability Index (CADI) Score Change [ Time Frame: Baseline to Week 12 ]
    Comparison of Change from Baseline to Week 12 in CADI Score between the various treatment arms. The CADI is a short 5 item questionnaire that will be responded by all subjects at Baseline, Week 4, 8, and 12. The questionnaire rapidly assesses the disability caused by the acne. It consists of 5 questions. The scoring for each question is done from 0 to 3 (a=3, b=2, c=1, d=0). The CADI score is calculated by summing the score of each question resulting in a possible maximum of 15 and a minimum of 0. The higher the score, the more the quality of life is impaired.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A 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
Official Title  ICMJE 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
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: Tazarotene 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: DFD-03 Lotion, 0.1%
  • Drug: Tazarotene 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: Tazorac Cream, 0.1%
  • Drug: 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.
  • Drug: 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.
Study Arms  ICMJE
  • 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
    Intervention: Drug: 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
    Intervention: Drug: Tazarotene Cream, 0.1%
  • Placebo Comparator: Vehicle Lotion
    Vehicle Lotion to be applied twice daily for 1 minute and rinsed off
    Intervention: Drug: Vehicle Lotion 0%
  • Placebo Comparator: Vehicle Cream
    Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours
    Intervention: Drug: Vehicle Cream 0%
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2018)
155
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2017)
150
Actual Study Completion Date  ICMJE May 18, 2018
Actual Primary Completion Date May 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03341910
Other Study ID Numbers  ICMJE DFD-03-CD-008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Reddy's Laboratories Limited
Study Sponsor  ICMJE Dr. Reddy's Laboratories Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Srinivas R. Sidgiddi, M.D. Dr. Reddy's Laboratories
PRS Account Dr. Reddy's Laboratories Limited
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP