A Phase 4 interventional study of Topicort® (desoximetasone) Topical Spray, 0.25% in Plaque Psoriasis, sponsored by Taro Pharmaceuticals USA. Completed at 1 site in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-03-28.
Sponsored by Taro Pharmaceuticals USA · Phase 4, Interventional, and Treatment
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's enrollment of 129 is above 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:
Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days
Drug: Topicort® (desoximetasone) Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Also known as: desoximetasone
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml
Time frame: 28 days
Adverse Event
The total number of subjects experiencing adverse events.
Time frame: 28 days
Cpre-ss
Concentration prior to dosing at steady state.
Time frame: 28 Days
The first patient enrolled in the study 23 January 2015. The last patient completed the study 22 November 2019. The Patients were enrolled in 3 cohorts. Cohort 1, 12 to 17 years and 11 months, Cohort 2, 6 year to 11 and 11 Months and Cohort 3, 2 years to 5 years and 11 months. In total 129 subjects were enrolled across 7 Investigator sites.
| Milestone | Topicort® Topical Spray, 0.25% |
|---|---|
| Started | 129 |
| Cohort 1 12-17 years of age | 84 |
| Cohort 2 6 to 11 years of age | 35 |
| Cohort 3 2 to 5 years of age | 10 |
| Completed | 106 |
| Not completed | 23 |
A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (\< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml
| Participants | Cohort 1 | Cohort 2 | Cohort 3 |
|---|---|---|---|
| The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test | 21 | 13 | 2 |
The total number of subjects experiencing adverse events.
| Participants | Topicort® Topical Spray, 0.25% |
|---|---|
| Adverse Event | 1 |
Concentration prior to dosing at steady state.
| pg/mL | Topicort® Topical Spray, 0.25% - Cohort 1 | Topicort® Topical Spray, 0.25% - Cohort 2 |
|---|---|---|
| Cpre-ss | 527.64 ± 574.47 | 475.41 ± 215.66 |
Collected over For each subject Adverse Events were collected during their 28 day treatment period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Topicort® Topical Spray, 0.25% | 0/129 (0%) | 0/129 (0%) | 0/129 (0%) |
| Age, Customized(Participants) | Topicort® Topical Spray, 0.25% |
|---|---|
| Cohort 1 - 12 to 17 years of age | 84 |
| Cohort 2- 6 to 11 years of age | 35 |
| Cohort 3 - 2 to 5 years of age | 10 |
| Sex: Female, Male(Participants) | Topicort® Topical Spray, 0.25% |
|---|---|
| Cohort 1 -12 to 17 years of age — Female | 35 |
| Cohort 1 -12 to 17 years of age — Male | 49 |
| Cohort 2 - 6 to 11 years of age — Female | 23 |
| Cohort 2 - 6 to 11 years of age — Male | 12 |
| Cohort 3- 2 to 5 years of age — Female | 4 |
| Cohort 3- 2 to 5 years of age — Male | 6 |
| Ethnicity (NIH/OMB)(Participants) | Topicort® Topical Spray, 0.25% |
|---|---|
| Hispanic or Latino | 126 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Topicort® Topical Spray, 0.25% |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 102 |
| More than one race | 0 |
| Unknown or Not Reported | 26 |
| Region of Enrollment(participants) | Topicort® Topical Spray, 0.25% |
|---|---|
| United States | 76 |
| Panama | 27 |
| El Salvador | 26 |
| Hypothalamic-Pituitary-Adrenal (HPA) Axis Function(Participants) | Topicort® Topical Spray, 0.25% |
|---|---|
| Cohort 1 - 12 to 17 years of age | 60 |
| Cohort 2 - 6 to 11 years of age | 30 |
| Cohort 3 - 2 to 5 years of age | 10 |
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Taro Pharmaceuticals USA