Acne Vulgaris
Conditions
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.
Interventions
DRUGDFD-03
DFD-03 Lotion
OTHERPlacebo Comparator
Vehicle (tazarotene 0%) Lotion
Sponsors
Dr. Reddy's Laboratories Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute Change in the Inflammatory Lesion Counts on the Face | 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 |
| Absolute Change in the Non-inflammatory Lesion Counts on the Face | 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 |
| Proportion of Subjects With Treatment Success Based on IGA Score | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active DFD-03 (0.1% tazarotene) Lotion
DFD-03: DFD-03 Lotion | 277 |
| Vehicle Vehicle (0% tazarotene) Lotion
Placebo Comparator: Vehicle (tazarotene 0%) Lotion | 273 |
| Total | 550 |
Baseline characteristics
| Characteristic | Active | Vehicle | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 91 Participants | 91 Participants | 182 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 186 Participants | 182 Participants | 368 Participants |
| Age, Continuous | 21.2 years STANDARD_DEVIATION 7.9 | 21.1 years STANDARD_DEVIATION 8 | 21.2 years STANDARD_DEVIATION 7.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 109 Participants | 105 Participants | 214 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 168 Participants | 168 Participants | 336 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 14 Participants | 7 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 51 Participants | 58 Participants | 109 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 12 Participants | 13 Participants | 25 Participants |
| Race (NIH/OMB) White | 200 Participants | 194 Participants | 394 Participants |
| Region of Enrollment United States | 277 Participants | 273 Participants | 550 Participants |
| Sex: Female, Male Female | 145 Participants | 158 Participants | 303 Participants |
| Sex: Female, Male Male | 132 Participants | 115 Participants | 247 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 277 | 0 / 273 |
| other Total, other adverse events | 0 / 277 | 0 / 273 |
| serious Total, serious adverse events | 2 / 277 | 1 / 273 |
Outcome results
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
Time frame: Baseline to Week 12
Population: Intent To Treat (ITT) Population - All subjects randomized and dispensed study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Absolute Change in the Inflammatory Lesion Counts on the Face | Baseline | 30.1 Lesions | Standard Deviation 9.81 |
| Active | Absolute Change in the Inflammatory Lesion Counts on the Face | Week 12 | 15.4 Lesions | Standard Deviation 11.43 |
| Vehicle | Absolute Change in the Inflammatory Lesion Counts on the Face | Baseline | 29.8 Lesions | Standard Deviation 9.13 |
| Vehicle | Absolute Change in the Inflammatory Lesion Counts on the Face | Week 12 | 16.9 Lesions | Standard Deviation 11.78 |
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
Time frame: Baseline to Week 12
Population: ITT Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Absolute Change in the Non-inflammatory Lesion Counts on the Face | Baseline | 37.4 Lesions | Standard Deviation 14.71 |
| Active | Absolute Change in the Non-inflammatory Lesion Counts on the Face | Week 12 | 20.3 Lesions | Standard Deviation 13.88 |
| Vehicle | Absolute Change in the Non-inflammatory Lesion Counts on the Face | Baseline | 36.6 Lesions | Standard Deviation 13.07 |
| Vehicle | Absolute Change in the Non-inflammatory Lesion Counts on the Face | Week 12 | 22.1 Lesions | Standard Deviation 18.26 |
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
Time frame: Baseline to Week 12
Population: ITT Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Active | Proportion of Subjects With Treatment Success Based on IGA Score | 51 Participants |
| Vehicle | Proportion of Subjects With Treatment Success Based on IGA Score | 34 Participants |