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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DFD-03 Lotion, 0.1% | Experimental | DFD-03 Lotion, 0.1% to be applied twice daily approximately 12 hours apart, for 1 minute and rinsed off |
|
| Tazorac Cream, 0.1% | Active Comparator | Tazorac Cream, 0.1% to be applied once in the evening and left overnight for approximately 12 hours |
|
| Vehicle Lotion | Placebo Comparator | Vehicle Lotion to be applied twice daily for 1 minute and rinsed off |
|
| Vehicle Cream | Placebo Comparator | Vehicle Cream to be applied once in the evening and left overnight for approximately 12 hours |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD-03 Lotion, 0.1% | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups | Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups. | Baseline to Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
Females who are pregnant or lactating or planning to become pregnant during the study period.
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.
Known allergic reaction to retinoids or tazarotene or any of the product ingredients.
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 treated for alcohol dependence or alcohol or drug abuse in the year.
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas R. Sidgiddi, M.D. | Dr. Reddy's Laboratories Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| International Dermatology Inc. | Miami | Florida | 33144 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 6, 2017 | Jun 23, 2020 |
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| Tazorac Cream, 0.1% | Drug | Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight. |
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| DFD-03 Vehicle Lotion 0% | Drug | 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. |
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| Tazorac Vehicle Cream 0% | Drug | Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight. |
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| Tazorac Cream, 0.1% |
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. |
| FG002 | DFD-03 Vehicle Lotion | 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. |
| FG003 | Tazorac Vehicle Cream | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Safety Population - All subjects who received study product and provided any post-baseline safety information.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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. |
| BG001 | Tazorac Cream, 0.1% | 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. |
| BG002 | DFD-03 Vehicle Lotion | 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. |
| BG003 | Tazorac Vehicle Cream | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
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| Primary | Adverse Event Occurences in DFD-03 Lotion Versus Tazorac Cream Groups | Frequency count of treatment emergent adverse events will be compared between DFD-03 Lotion and Tazorac Cream groups. | Safety Population - All subjects who received study product and provided any post baseline safety information. | Posted | Number | Adverse Events | Baseline to Week 12 |
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Adverse events were collected from treatment initiation until study product treatment discontinuation (approximately 12 weeks).
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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DFD-03 Lotion, 0.1% | 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. | 0 | 54 | 0 | 54 | 22 | 54 |
| EG001 | Tazorac Cream, 0.1% | 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. | 0 | 49 | 0 | 49 | 26 | 49 |
| EG002 | Vehicle Lotion | 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. | 0 | 26 | 0 | 26 | 9 | 26 |
| EG003 | Vehicle Cream | 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. | 0 | 26 | 0 | 26 | 11 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application site dryness | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Application site exfoliation | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Application Site Pain | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Application Site Erythema | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Application Site Pruritus | General disorders | MedDRA 20.0 | Systematic Assessment |
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| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Srinivas Sidgiddi, Sr. Director, Clinical Development | Dr. Reddy's Laboratories, Inc | 609-375-9910 | srinivassidgiddi@drreddys.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 11, 2018 | Jun 23, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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