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A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris (DFD-03)

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: NCT03290027
Recruitment Status : Completed
First Posted : September 21, 2017
Last Update Posted : August 29, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Reddy's Laboratories Limited

Brief Summary:

Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any severity on the chest and/or back (including shoulders) may be enrolled provided they have mild to moderate acne on the face. During the 12-week treatment period subjects will use the study product twice daily. Subjects will be instructed to treat the entire face (and chest and/or back including shoulders, if applicable).

Efficacy will be assessed by using an Investigator's Global Assessment scale (IGA 5 point scale) and by counting the number of inflammatory and non-inflammatory lesions on the face at Baseline and Weeks 4, 8, and 12.

Safety assessments will include the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching; assessed separately on the chest and/or back including shoulders (if applicable), vital signs (blood pressure and pulse rate), and adverse events (AEs). Urine pregnancy tests will be performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination will be performed.


Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: DFD-03 Other: Placebo Comparator Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled Study of the Safety and Efficacy of DFD-03 Lotion in the Treatment of Acne Vulgaris for 12 Weeks
Actual Study Start Date : July 31, 2017
Actual Primary Completion Date : April 19, 2018
Actual Study Completion Date : April 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Tazarotene

Arm Intervention/treatment
Experimental: Active
DFD-03 (0.1% tazarotene) Lotion
Drug: DFD-03
DFD-03 Lotion
Other Name: Tazarotene 0.1% Lotion

Placebo Comparator: Vehicle
Vehicle (0% tazarotene) Lotion
Other: Placebo Comparator
Vehicle (tazarotene 0%) Lotion
Other Name: Vehicle




Primary Outcome Measures :
  1. Absolute change in the inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]
    Change in inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using a two way analysis of covariance (ANCOVA) model

  2. Absolute change in the non-inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]
    Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model

  3. Proportion of subjects with treatment success based on IGA score [ Time Frame: Baseline to Week 12 ]
    IGA success at Week 12 (an IGA score of 0 (Clear) or 1 (almost clear) with at least a 2-grade reduction from baseline) - will be analyzed using the Cochran-Mantel-Haenszel (CMH) test for general association


Secondary Outcome Measures :
  1. Percent change in inflammatory and non-inflammatory lesion counts on the face [ Time Frame: Baseline to Week 12 ]
    The percent change from Baseline to Week 12 in inflammatory and non-inflammatory lesion counts on the face will be analyzed using a two-way analysis of covariance (ANCOVA) model



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

Main Inclusion Criteria:

  1. Subject must be at least 9 years of age.
  2. A clinical diagnosis of mild to moderate facial acne vulgaris.
  3. Inflammatory lesion count (papules and pustules) of at least 20 on the face, Non-inflammatory lesion count (closed and open comedones) of at least 25 on the face and No more than 2 nodulocystic lesions on the face.
  4. Females, regardless of childbearing potential, if sexually active, must be on or use an acceptable method of birth control.
  5. Subject must be in good general health as determined by the investigator and supported by medical history, physical and Vital Signs exam.

Main Exclusion Criteria:

  1. Females who are pregnant or lactating or planning to become pregnant.
  2. Treatment with the following products:

    1. Topical acne treatments or other topical facial medication on the treatment area.
    2. Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne.
    3. Systemic retinoid use.
    4. 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).
    5. 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.
    6. Treatment with an investigational product or device in the 30 days.
  3. Known allergic reaction to retinoids or tazarotene.
  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 in another investigational trial within 30 days.

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): NCT03290027


Locations
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United States, Texas
Dr. Seemal
Plano, Texas, United States, 75024
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
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Study Director: Srinivas R. Sidgiddi, M.D. Dr. Reddy's Laboratories

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Responsible Party: Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT03290027     History of Changes
Other Study ID Numbers: DFD-03-CD-005
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019

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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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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Tazarotene
Dermatologic Agents
Keratolytic Agents