Atopic Dermatitis
Conditions
Brief summary
Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Detailed description
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Design, Multiple-Site Clinical Study to Evaluate the Efficacy and Safety of DSXS (Taro Pharmaceuticals, U.S.A., Inc.) in Patients with Moderate to Severe Atopic Dermatitis
Interventions
DRUGDSXS
Active treatment
DRUGPlacebo
Placebo treatment
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
\- male and non-pregnant females, age 6 months or older, with a confirmed diagnosis of moderate to severe atopic dermatitis (AD)
Exclusion criteria
\- Lacks stable diagnosis of atopic dermatitis or has been diagnosed with mild atopic dermatitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Patients in Each Treatment Group That Have Clinical Success | 28 days | Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear \[0\] or almost clear \[1\]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in %BSA Affected at Day 28 ± 2 | 28 days | The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS Topical Product DSXS Active treatment
DSXS: Active treatment | 61 |
| Placebo Topical Product Placebo treatment
Placebo: Placebo treatment | 63 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Progressive Disease | 0 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
Baseline characteristics
| Characteristic | Placebo Topical Product | Total | DSXS Topical Product |
|---|---|---|---|
| Age, Continuous | 41.7 years STANDARD_DEVIATION 18.5 | 42.6 years STANDARD_DEVIATION 18.6 | 43.5 years STANDARD_DEVIATION 18.8 |
| Baseline Investigator Global Assessment (IGA) Score Almost Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline Investigator Global Assessment (IGA) Score Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline Investigator Global Assessment (IGA) Score Mild Disease | 0 Participants | 0 Participants | 0 Participants |
| Baseline Investigator Global Assessment (IGA) Score Moderate Disease | 56 Participants | 109 Participants | 53 Participants |
| Baseline Investigator Global Assessment (IGA) Score Severe Disease | 7 Participants | 15 Participants | 8 Participants |
| Baseline Total Body Surface Area (BSA) | 1.9 meters squared STANDARD_DEVIATION 0.3 | 1.9 meters squared STANDARD_DEVIATION 0.3 | 1.8 meters squared STANDARD_DEVIATION 0.2 |
| %BSA Affected with Atopic Dermatitis (AD) | 23.3 percent STANDARD_DEVIATION 10.1 | 23.4 percent STANDARD_DEVIATION 8.9 | 23.4 percent STANDARD_DEVIATION 7.5 |
| Eczema Area and Severity Index (EASI) Score | 18.6 units on a scale STANDARD_DEVIATION 3.6 | 18.7 units on a scale STANDARD_DEVIATION 4 | 18.8 units on a scale STANDARD_DEVIATION 4.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 31 Participants | 56 Participants | 25 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 68 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 17 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 4 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 | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 99 Participants | 46 Participants |
| Sex: Female, Male Female | 32 Participants | 68 Participants | 36 Participants |
| Sex: Female, Male Male | 31 Participants | 56 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 63 |
| other Total, other adverse events | 8 / 61 | 13 / 63 |
| serious Total, serious adverse events | 0 / 61 | 0 / 63 |
Outcome results
Primary
The Number of Patients in Each Treatment Group That Have Clinical Success
Clinical Success defined using the following scores at Visit 4 (Day 28 ± 2): At least a 2-grade improvement from the baseline IGA score (i.e., clear \[0\] or almost clear \[1\]) AND A score of clear or mild (0 or 1) for both erythema and induration/papulation/edema
Time frame: 28 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DSXS Topical Product | The Number of Patients in Each Treatment Group That Have Clinical Success | 21 Participants |
| Placebo Topical Product | The Number of Patients in Each Treatment Group That Have Clinical Success | 27 Participants |
p-value: 0.3353z-test, 2-tailed
Secondary
Change From Baseline in %BSA Affected at Day 28 ± 2
The change in %BSA Affected from Visit 1 Baseline (Day 1) to Visit 4 End of Treatment (Day 28 ± 2)
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DSXS Topical Product | Change From Baseline in %BSA Affected at Day 28 ± 2 | -13.81 percentage of BSA | Standard Error 0.99 |
| Placebo Topical Product | Change From Baseline in %BSA Affected at Day 28 ± 2 | -13.24 percentage of BSA | Standard Error 0.96 |
p-value: 0.619ANCOVA