A Phase 4 interventional study of Halobetasol Topical Foam in Plaque Psoriasis, sponsored by Mayne Pharma International Pty Ltd. Completed at 11 sites in 4 countries. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Mayne Pharma International Pty Ltd · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate Halobetasol Propionate (HBP) foam, 0.05% in subjects aged 12 through less than 18 years with plaque psoriasis in order to check the safety, the potential to suppress the adrenal glands and the degree to which the drug is absorbed into the bloodstream.
This is a Phase 4 (for US site only, Phase 2 for non-US sites), open label, multicenter study of halobetasol propionate (HBP) Foam, 0.05% in male and female subjects who are 12 to less than 18 years of age with stable plaque psoriasis. Twenty-four subjects with stable plaque psoriasis on at least 10% of their body surface area (BSA) (excluding the face, scalp, groin, axillae, and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites in the US and Europe. All subjects are to have a Cosyntropin Stimulation Test (CST) to assess their (hypothalmic pituitary adrenal) HPA axis response at Visit 1/Screening initiated between 7 and 9 AM. Enrollment into the treatment phase of the study will be timed such that the Screening CST is performed a minimum of 20 days before Visit 2/Baseline. At Visit 2/Baseline, eligible subjects with normal adrenal function will be eligible to participate in the study.
The primary objective of the study is to assess safety, not efficacy. Safety will be determined by assessing the adrenal suppression potential and the PK properties of HBP Foam, 0.05% applied twice daily in male and female subjects who were 12 to less than 18 years of age with stable plaque psoriasis.
Other safety endpoints include plasma levels of HBP. Trough HBP concentrations in plasma on day 8 and 15 will be calculated and summarized. Efficacy will also be noted utilizing the Investigator's Global Assessment (IGA) scale and percent BSA treated and affected with disease to assess and document any changes observed with regard to IGA and percent BSA.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's enrollment of 24 is below the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Mayne Pharma International Pty Ltd is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
2 weeks of application, 2 times daily
Drug: Halobetasol Topical Foam
Foam
Also known as: HBP Foam
Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test
A subject is considered to have adrenal suppression evidence if post cosyntropin stimulation lab draw result is less than or equal to 18.0 mcg/100 mL. HPA axis responses to cosyntropin were dichotomized to normal and abnormal. Cosyntropin stimulation testing was performed at Screening and Day 15 and approximately 4 weeks post-treatment if a subject's laboratory results at Day 15 showed an abnormal hypothalamic pituitary adrenal (HPA) axis response (HPA axis suppression). An abnormal HPA axis response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS).
Time frame: Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days
Plasma Concentration of HBP at Screening, Day 8 and Day 15
Morning trough concentrations of HBP in plasma at Screening, Day 8, and Day 15 were summarized for the PK population using geometric mean, coefficient of variation in addition to n, mean, median, standard deviation (SD), minimum, and maximum.
Time frame: 15 days
| Milestone | Halobetasol Propionate Foam, 0.05% |
|---|---|
| Started | 24 |
| Completed | 24 |
| Not completed | 0 |
A subject is considered to have adrenal suppression evidence if post cosyntropin stimulation lab draw result is less than or equal to 18.0 mcg/100 mL. HPA axis responses to cosyntropin were dichotomized to normal and abnormal. Cosyntropin stimulation testing was performed at Screening and Day 15 and approximately 4 weeks post-treatment if a subject's laboratory results at Day 15 showed an abnormal hypothalamic pituitary adrenal (HPA) axis response (HPA axis suppression). An abnormal HPA axis response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS).
| Participants | Halobetasol Propionate Foam |
|---|---|
| Abnormal HPA Axis Response | 6 |
| Normal HPA Axis Response | 17 |
Morning trough concentrations of HBP in plasma at Screening, Day 8, and Day 15 were summarized for the PK population using geometric mean, coefficient of variation in addition to n, mean, median, standard deviation (SD), minimum, and maximum.
| Participants | Halobetasol Propionate Foam, 0.05% |
|---|---|
| Baseline number of participants with plasma morning trough concentrations below limits | 23 |
| Day 8 number of participants with plasma morning trough concentrations below limits | 14 |
| Day 15/EOS number of participants with plasma morning trough concentrations below limits | 13 |
| Day 8 Subjects with measurable levels of HBP at morning trough | 9 |
| Day 15/EOS Subjects with measurable levels of HBP at morning trough | 6 |
Collected over Collected at study visits, days 1, 8, and 15.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Halobetasol Propionate Foam, 0.05% | 0/24 (0%) | 0/24 (0%) | 7/24 (29.2%) |
| Event | Halobetasol Propionate Foam, 0.05% |
|---|---|
| ACTH Stimulation Test AbnormalEndocrine disorders | 7/24 |
| Local skin reactionsSkin and subcutaneous tissue disorders | 6/24 |
| Age, Categorical(Participants) | Halobetasol Propionate Foam |
|---|---|
| <=18 years | 24 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Halobetasol Propionate Foam |
|---|---|
| Female | 11 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Halobetasol Propionate Foam |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 18 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Halobetasol Propionate Foam |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 24 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2019 to primary completion in Dec 2019, 6 months.
Results were first posted in Jul 2023, 3 years 6 months after primary completion.
Of 40 industry-sponsored phase 4 interventional studies under Psoriasis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 29. This study's 6 months is below that.
Counting every sponsor, half of 115 studies reached it within 23 months; a quarter within 12 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Mayne Pharma International Pty Ltd