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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | DFD-03 (0.1% tazarotene) Lotion |
|
| Vehicle | Placebo Comparator | Vehicle (0% tazarotene) Lotion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DFD-03 | Drug | DFD-03 Lotion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 12 |
| 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 | Baseline to Week 12 |
| 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 | Baseline to Week 12 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
Females who are pregnant or lactating or planning to become pregnant.
Treatment with the following products:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Srinivas Sidgiddi, M.D. | Dr. Reddy's Laboratories Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Seemal | Plano | Texas | 75024 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | DFD-03 (0.1% tazarotene) Lotion DFD-03: DFD-03 Lotion |
| FG001 | Vehicle | Vehicle (0% tazarotene) Lotion Placebo Comparator: Vehicle (tazarotene 0%) Lotion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Intent to Treat (ITT) - The ITT population was the primary efficacy analysis data set and consisted of all subjects who were randomized and dispensed study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | DFD-03 (0.1% tazarotene) Lotion DFD-03: DFD-03 Lotion |
| BG001 | Vehicle | Vehicle (0% tazarotene) Lotion Placebo Comparator: Vehicle (tazarotene 0%) Lotion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication. | Posted | Mean | Standard Deviation | Lesions | Baseline to Week 12 | Lesions | Lesions |
|
Adverse event data were collected from the time treatment was initiated until study product treatment was discontinued, except for spontaneously reported SAEs, which were to be reported up to 30 days after discontinuing study product use.
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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 | Active | DFD-03 (0.1% tazarotene) Lotion DFD-03: DFD-03 Lotion | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | MedRA 20.0 | Systematic Assessment | Worsening of Anxiety |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Srinivas Sidgiddi | Dr. Reddys Laboratories Inc. | 9084585362 | srinivassidgiddi@drreddys.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 2, 2017 | Apr 6, 2020 | Prot_SAP_000.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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| ID | Term |
|---|---|
| C086827 | tazarotene |
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| Placebo Comparator | Other | Vehicle (tazarotene 0%) Lotion |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Lesions |
|
|
| Primary | 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 | ITT Population | Posted | Mean | Standard Deviation | Lesions | Baseline to Week 12 |
|
|
|
| Primary | 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 | ITT Population | Posted | Count of Participants | Participants | Baseline to Week 12 |
|
|
|
| 277 |
| 2 |
| 277 |
| 0 |
| 277 |
| EG001 | Vehicle | Vehicle (0% tazarotene) Lotion Placebo Comparator: Vehicle (tazarotene 0%) Lotion | 0 | 273 | 1 | 273 | 0 | 273 |
| Polyps/Epithelioid | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedRA 20.0 | Systematic Assessment |
|
| Overian cyst ruptured | Reproductive system and breast disorders | MedRA 20.0 | Systematic Assessment |
|
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