Plaque PsoriasisPhase 4NCT03992261
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
A Phase 4 study testing Halobetasol Topical Foam in people with Plaque Psoriasis, run by Mayne Pharma International Pty Ltd at 11 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Halobetasol Topical Foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 11 sitesin 4 countries
- Study dates
- 14 Jun 2019to 30 Dec 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is male or non-pregnant female and is 12 to less than 18 years of age
- Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing
- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% Body Surface Area (BSA)
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit
Who cannot join
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation
- Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation
- Subject is pregnant, lactating, or is planning to become pregnant during the study
- Subject is currently enrolled in an investigational drug or device study
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Georgia3 sites
Investigative Site 9
Batumi
Investigative Site 10
Tbilisi, 0114
Investigative Site 11
Tbilisi, 0177
Poland3 sites
Investigative Site 3
Krakow
Investigative Site 5
Tarnów
Investigative Site 4
Warsaw
Ukraine3 sites
Investigative Site 8
Rivne
Investigative Site 6
Uzhhorod
Investigative Site 7
Zaporizhzhya
United States2 sites
Investigative Site 2
Hialeah, Florida, 33012
Investigative Site 1
Saint Joseph, Missouri, 64506
About this study
Official title: Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Foam, 0.05% in Subjects 12 to Less Than 18 Years of Age With Plaque Psoriasis Receiving Two Weeks of 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.
Read the detailed description
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.
- Conditions
- Plaque Psoriasis
- Being tested
- Halobetasol Topical Foam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halobetasol Topical FoamDrug
Also called HBP Foam
Foam
| Study group | Role | What they receive |
|---|---|---|
| Halobetasol Propionate Foam | Experimental | 2 weeks of application, 2 times daily Receives: Drug: Halobetasol Topical Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start14 Jun 2019
- Primary completion30 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayne Pharma International Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel J Piacquadio, MD, Study director, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992261
- Sponsor's protocol ID
- 122-0551-209
- Status last verified
- Mar 2023
- First submitted
- 18 Jun 2019
- Last updated
- 6 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Foam, 0.05% in Subjects 12 to Less Than 18 Years of Age With Plaque Psoriasis Receiving Two Weeks of Treatment
- ClinicalTrials.gov ID
- NCT03992261
- Acronym / sponsor ID
- 122-0551-209
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Mayne Pharma International Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2019 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Posted 6 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Halobetasol Propionate Foam | Experimental | Drug: Halobetasol Topical Foam2 weeks of application, 2 times daily |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subject is male or non-pregnant female and is 12 to less than 18 years of age
- Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing
- Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% Body Surface Area (BSA)
- Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit
Key exclusion criteria (6 listed)
- Subject has spontaneously improving or rapidly deteriorating plaque psoriasis
- Subject has guttate, pustular, erythrodermic or other non-plaque forms of psoriasis
- Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation
- Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation
- Subject is pregnant, lactating, or is planning to become pregnant during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Halobetasol Topical FoamAlso: HBP FoamFoam | Drug | Halobetasol Propionate Foam |
Primary outcome
Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test
Time frame: Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days
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).
Plasma Concentration of HBP at Screening, Day 8 and Day 15
Time frame: 15 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel J Piacquadio, MD study director
Therapeutics, Inc.
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Halobetasol Topical Foam in people with Plaque Psoriasis, run by Mayne Pharma International Pty Ltd at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Georgia, Poland, Ukraine, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects to Exhibit Adrenal Suppression as Measured by a Cosyntropin Stimulation Test (time frame: Screening, Day 15, and approximately 4 weeks post-treatment, an average of 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.