Back to resultsA Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris (DFD-03)
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DFD-03
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Main Inclusion Criteria:
- Subject must be at least 9 years of age.
- A clinical diagnosis of mild to moderate facial acne vulgaris.
- 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.
- Females, regardless of childbearing potential, if sexually active, must be on or use an acceptable method of birth control.
- 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:
- Females who are pregnant or lactating or planning to become pregnant.
Treatment with the following products:
- Topical acne treatments or other topical facial medication on the treatment area.
- Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne.
- Systemic retinoid use.
- 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).
- 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 the 30 days.
- Known allergic reaction to retinoids or tazarotene.
- 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.
- 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.
- Subjects who have been in another investigational trial within 30 days.
Sites / Locations
- Dr. Seemal
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active
Vehicle
Arm Description
DFD-03 (0.1% tazarotene) Lotion
Vehicle (0% tazarotene) Lotion
Outcomes
Primary Outcome Measures
Absolute Change in the Inflammatory Lesion Counts on the Face
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
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model
Proportion of Subjects With Treatment Success Based on IGA Score
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
Full Information
NCT ID
NCT03290027
First Posted
September 19, 2017
Last Updated
February 4, 2021
Sponsor
Dr. Reddy's Laboratories Limited
1. Study Identification
Unique Protocol Identification Number
NCT03290027
Brief Title
A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris
Acronym
DFD-03
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
April 19, 2018 (Actual)
Study Completion Date
April 19, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. Reddy's Laboratories Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Enrollment of subjects with mild to moderate facial acne. Efficacy was 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 included the investigator's assessment of local cutaneous tolerance of the treated skin (dryness, non-lesional erythema, peeling, stinging, burning, and itching, vital signs, and adverse events (AEs).
Detailed Description
Enrollment of subjects with mild to moderate facial acne. Subjects with acne lesions of any severity on the chest and/or back (including shoulders) were enrolled provided they had mild to moderate acne on the face. During the 12-week treatment period subjects used the study product twice daily. Subjects were instructed to treat the entire face (and chest and/or back including shoulders, if applicable).
Efficacy was 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 included 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 were performed at Baseline and at every visit through Week 12 for all female subjects. A physical examination was performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active
Arm Type
Experimental
Arm Description
DFD-03 (0.1% tazarotene) Lotion
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle (0% tazarotene) Lotion
Intervention Type
Drug
Intervention Name(s)
DFD-03
Other Intervention Name(s)
Tazarotene 0.1% Lotion
Intervention Description
DFD-03 Lotion
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle (tazarotene 0%) Lotion
Primary Outcome Measure Information:
Title
Absolute Change in the Inflammatory Lesion Counts on the Face
Description
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
Time Frame
Baseline to Week 12
Title
Absolute Change in the Non-inflammatory Lesion Counts on the Face
Description
Change in non-inflammatory lesion counts on the face from baseline to Week 12 - will be analyzed using the same ANCOVA model
Time Frame
Baseline to Week 12
Title
Proportion of Subjects With Treatment Success Based on IGA Score
Description
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
Time Frame
Baseline to Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
Subject must be at least 9 years of age.
A clinical diagnosis of mild to moderate facial acne vulgaris.
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.
Females, regardless of childbearing potential, if sexually active, must be on or use an acceptable method of birth control.
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:
Females who are pregnant or lactating or planning to become pregnant.
Treatment with the following products:
Topical acne treatments or other topical facial medication on the treatment area.
Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne.
Systemic retinoid use.
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).
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 the 30 days.
Known allergic reaction to retinoids or tazarotene.
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.
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.
Subjects who have been in another investigational trial within 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Srinivas Sidgiddi, M.D.
Organizational Affiliation
Dr. Reddy's Laboratories Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Dr. Seemal
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of the Safety and Efficacy of DFD-03 for the Treatment of Acne Vulgaris
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