Scalp Psoriasis
Conditions
Brief summary
An Open-Label, Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use DSXS topical product (Taro Pharmaceuticals U.S.A., Inc.) in Patients with Moderate to SevereScalp Psoriasis
Detailed description
* Evaluate the potential of DSXS topical product to suppress HPA axis function in patients with moderate to severe scalp psoriasis. * Evaluate the efficacy parameters and adverse event (AE) profiles of DSXS topical product administered to patients with moderate to severe scalp psoriasis.
Interventions
treatment daily for 28 days
Sponsors
Sun Pharmaceutical Industries, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
Inclusion criteria
* Male or non-pregnant, non-lactating females 12-17 years of age.
Exclusion criteria
* Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of child-bearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With HPA Axis Suppression | day 28 | Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| DSXS Topical Product treatment with DSXS once daily for 28 days
DSXS topical product: treatment daily for 28 days | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | DSXS Topical Product |
|---|---|
| Age, Continuous | 15.0 years STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Percent Scalp Affected with Plaque Psoriasis | 28.3 percent of scalp STANDARD_DEVIATION 2.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Number of Participants With HPA Axis Suppression
Hypothalamic Pituitary Adrenal (HPA) Axis Response to stimulation
Time frame: day 28
Population: Two patients who had normal adrenal function at baseline, used at least 21 doses of the study product, and had data from a post-treatment cortisol response test were included in the analysis. One patient was excluded from the analysis of HPA axis suppression owing to abnormal adrenal function at baseline.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| DSXS Topical Product | Number of Participants With HPA Axis Suppression | Yes | 0 Participants |
| DSXS Topical Product | Number of Participants With HPA Axis Suppression | No | 2 Participants |