A Phase 2 interventional study of DSXS in Plaque Psoriasis, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2018-12-07.
Sponsored by Taro Pharmaceuticals USA · Phase 2, Interventional, and Treatment
An open label, safety study to assess the potential for adrenal suppression following maximal use treatment with DSXS administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 26 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.
Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
administered twice daily for 28 days in patients with moderate to severe plaque psoriasis.
Drug: DSXS
twice daily for 28 days
Also known as: Active
Number of Participants With HPA Axis Suppression
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
Time frame: 28 days
| Milestone | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 |
|---|---|---|
| Started | 25 | 1 |
| Completed | 24 | 1 |
| Not completed | 1 | 0 |
| Withdrew: Enrolled in error | 1 | 0 |
Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression at the end of treatment. HPA Axis suppression is defined as a 30 minute post CortrosynTM injection level cortisol level of ≤ 18 mcg/100ml.
| Participants | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 |
|---|---|---|
| Yes | 3 | 0 |
| No | 21 | 1 |
Collected over 1 year, 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DSXS1503 Cohort 1 | 0/25 (0%) | 0/25 (0%) | 7/25 (28%) |
| DSXS1503 Cohort 2 | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Event | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 |
|---|---|---|
| Abdominal painGastrointestinal disorders | 1/25 | 0/1 |
| DiarrhoeaGastrointestinal disorders | 1/25 | 0/1 |
| Application site irritationGeneral disorders | 1/25 | 0/1 |
| NasopharyngitisInfections and infestations | 1/25 | 0/1 |
| ACTH stimulation test abnormalInvestigations | 1/25 | 0/1 |
| BursitisMusculoskeletal and connective tissue disorders | 1/25 | 0/1 |
| HeadacheNervous system disorders | 1/25 | 0/1 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/25 | 0/1 |
| Age, Continuous(years) | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 | Total |
|---|---|---|---|
| Mean | 56.72 ± 12.90 | 17.00 | 55.19 ± 14.85 |
| Sex: Female, Male(Participants) | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 | Total |
|---|---|---|---|
| Female | 10 | 1 | 11 |
| Male | 15 | 0 | 15 |
| Ethnicity (NIH/OMB)(Participants) | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 | Total |
|---|---|---|---|
| Hispanic or Latino | 25 | 1 | 26 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 24 | 1 | 25 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Baseline Total BSA(meters squared) | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 | Total |
|---|---|---|---|
| Mean | 2.11 ± 0.30 | 1.83 | 2.10 ± 0.30 |
| Baseline IGA(Participants) | DSXS1503 Cohort 1 | DSXS1503 Cohort 2 | Total |
|---|---|---|---|
| Clear | 0 | 0 | 0 |
| Minimal | 0 | 0 | 0 |
| Mild | 0 | 0 | 0 |
| Moderate | 20 | 1 | 21 |
| Severe | 5 | 0 | 5 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Taro Pharmaceuticals USA