Plaque PsoriasisPhase 4NCT03212963
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
A Phase 4 study testing Halobetasol Topical Lotion in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited at 3 sites in United States.
Trial summary
The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Halobetasol Topical Lotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Mar 2017to 12 Aug 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject is male or non-pregnant female and is 12 to 16 years 11 months of age.
- Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian has provided informed consent for the subject. 3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% body surface area (BSA) within the Treatment Area. The "Treatment Area" is defined as the entire body exclusive of the face, scalp, groin, axillae, and other intertriginous areas.
- 4. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
- 5. Subject is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- 6. Females must have a negative urine pregnancy test (UPT) at the Screening and Baseline Visits and agree to use an effective form of birth control for the duration of the study.
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 (e.g., Addison's Disease, Cushing's Syndrome) or which exposes the subject to an unacceptable risk by study participation.
- Subject has used any phototherapy (including laser), photochemotherapy or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within 30 days prior to the initiation of treatment with the test article.
- Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled or intranasal corticosteroids within 30 or 14 days, respectively, prior to Part B of the Screening Visit and/or the subject has used systemic or topical corticosteroids between Part B of the Screening Visit and the initiation of treatment.
- Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation within 30 days prior to the initiation of treatment or is intending to have such exposure during the study that is thought by the investigator to likely modify the subject's disease.
Show all 18Show fewer
- Subject has used topical psoriatic therapy including tar, anthralin, retinoids, vitamin D analogs (e.g., Dovonex®) within 14 days prior to the initiation of treatment with the test article.
- Subject has used emollients/moisturizers on areas to be treated within one day prior to the initiation of treatment with the test article.
- Subject is currently using lithium or Plaquenil (hydroxychloroquine).
- Subject is currently using a beta-blocking medication (e.g., propranolol) or angiotensin converting enzyme (ACE) inhibitors (e.g., lisinopril) at a dose that has not been stabilized, in the opinion of the investigator.
- Subject has a history of sensitivity to any of the ingredients in the test article.
- Subject is pregnant, lactating, or is planning to become pregnant during the study.
- Subject is currently enrolled in an investigational drug or device study.
- Subject has used an investigational drug or investigational device treatment within 30 days prior to Visit 1 (Screening).
- Subject has been previously enrolled in this study and treated with the test article.
- Subject has an irregular sleep schedule or works night shifts (cortisol levels exhibit physiological diurnal variation).
- Subject has a screening Cosyntropin Stimulation Test (CST) with a post 30-minute stimulation cortisol level of less than equal to 18 μg/dL.
- Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion
Trial locations and contacts
3 sites in 1 country.
United States3 sites
First OC Dermatology
Fountain Valley, California, 92708
Power MD Clinical Research Institute
Hialeah, Florida, 33012
MediSearch Clinical Trials
Saint Joseph, Missouri, 64506
About this study
Official title: An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Lotion, 0.05% in Subjects 12 to 16 Years 11 Months of Age With Plaque Psoriasis Receiving Two Weeks of Treatment
The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Subject enrollment will continue until at least 20 subjects with both screening and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have completed the study without any significant protocol violations (evaluable subjects). This may require the enrollment of approximately 25 subjects.
Read the detailed description
This is an open label, multicenter study of an investigational formulation of HBP Lotion, 0.05% in male and female subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Approximately 25 subjects with stable plaque psoriasis on at least 10% of their BSA (excluding the face, scalp, groin, axillae and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites. All subjects will have a screening CST to assess their HPA axis response at Visit 1 (Screening Visit).
Enrollment into the treatment phase of the study should be timed such that the screening CST will be performed a minimum of 20 days before Baseline Visit. At Visit 2 (Baseline), eligible subjects with normal adrenal function will be eligible to participate in the study.
Subjects will apply HBP Lotion, 0.05% to all psoriasis plaques identified at Visit 2 twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verifies the subject's psoriasis has cleared. The study is designed to determine the adrenal suppression potential and pharmacokinetic properties of the test article after the subject applies a maximum of approximately 50 grams per week for up to a two week treatment period. All subjects will have a CST to reassess their HPA axis response at EOS (or earlier if the investigator verifies the subject's psoriasis has cleared). In this study, an abnormal Hypothalamujs Pituitary Adrenal axis response to 0.25 milligram dose of cosyntropin is defined as a post-CST serum total cortisol level of less than equal to18 μg/dL.
Eligible subjects will have blood drawn at Screening for baseline drug concentration in plasma. On Day 8, all subjects, regardless of lesion clearance, will have blood drawn for assessment of trough drug concentration in plasma. At the Day 15 visit, subjects who have continued to treat lesions will have a final PK blood sample collected approximately 12 hours after their Day 14 evening application and just prior to the initiation of the CST.
- Conditions
- Plaque Psoriasis
- Being tested
- Halobetasol Topical Lotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halobetasol Topical LotionDrug
Also called Halobetasol topical lotion 0.05%
Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
| Study group | Role | What they receive |
|---|---|---|
| Halobetasol lotion treatment arm | Experimental | All subjects will receive Halobetasol Topical Lotion, 0.05%. Receives: Drug: Halobetasol Topical Lotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator's Global Assessment
The IGA score (5-point scale of 0 to 4: 0[clear]; 1[almost clear]; 2[mild]; 3[moderate]; 4[severe]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).
Measured: Day 15
Percent BSA Affected With Disease
The Percent Body Surface Area (BSA) Affected with Disease was defined as the BSA which was affected with psoriasis within the Treatment Area.
Measured: Day 15
Percent Body Surface Area Treated With Test Article
The Percent Body Surface Area Treated with Test Article was defined as the BSA which was affected with psoriasis within the Treatment Area that was treated.
Measured: Day 8
Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response
An abnormal Hypothalamus-Pituitary-Adrenal (HPA) axis was response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start21 Mar 2017
- Primary completion12 Aug 2019
- Study completion12 Aug 2019
Why it stopped: Sponsor's Decision
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.
- More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study to evaluate adrenal suppression potential and pharmacokinetics of halobetasol lotion 0.05%
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephanie Magajna, MS, Study chair, Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212963
- Sponsor's protocol ID
- 177-0551-201
- Status last verified
- Dec 2021
- First submitted
- 18 Apr 2017
- Last updated
- 7 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of Twice Daily Halobetasol Propionate Lotion, 0.05% in Subjects 12 to 16 Years 11 Months of Age With Plaque Psoriasis Receiving Two Weeks of Treatment
- ClinicalTrials.gov ID
- NCT03212963
- Acronym / sponsor ID
- 177-0551-201
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor's Decision
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- 12 Aug 2019 (actual)
- Study completion
- 12 Aug 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Posted 7 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this open-label multicentric study is to determine the adrenal suppression potential and the pharmacokinetic (PK) properties of halobetasol lotion (HBP) applied twice daily for up to two weeks in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Subject enrollment will continue until at least 20 subjects with both screening and end of study (EOS) serum cortisol data (pre- and pos-tcosyntropin stimulation) have completed the study without any significant protocol violations (evaluable subjects). This may require the enrollment of approximately 25 subjects.
Detailed description
This is an open label, multicenter study of an investigational formulation of HBP Lotion, 0.05% in male and female subjects aged 12 to 16 years 11 months with stable plaque psoriasis. Approximately 25 subjects with stable plaque psoriasis on at least 10% of their BSA (excluding the face, scalp, groin, axillae and other intertriginous areas), who fulfill the inclusion/exclusion criteria will be enrolled at multiple study sites. All subjects will have a screening CST to assess their HPA axis response at Visit 1 (Screening Visit).
Enrollment into the treatment phase of the study should be timed such that the screening CST will be performed a minimum of 20 days before Baseline Visit. At Visit 2 (Baseline), eligible subjects with normal adrenal function will be eligible to participate in the study.
Subjects will apply HBP Lotion, 0.05% to all psoriasis plaques identified at Visit 2 twice daily (approximately every 12 hours) for the assigned treatment period or until the investigator verifies the subject's psoriasis has cleared. The study is designed to determine the adrenal suppression potential and pharmacokinetic properties of the test article after the subject applies a maximum of approximately 50 grams per week for up to a two week treatment period. All subjects will have a CST to reassess their HPA axis response at EOS (or earlier if the investigator verifies the subject's psoriasis has cleared). In this study, an abnormal Hypothalamujs Pituitary Adrenal axis response to 0.25 milligram dose of cosyntropin is defined as a post-CST serum total cortisol level of less than equal to18 μg/dL.
Eligible subjects will have blood drawn at Screening for baseline drug concentration in plasma. On Day 8, all subjects, regardless of lesion clearance, will have blood drawn for assessment of trough drug concentration in plasma. At the Day 15 visit, subjects who have continued to treat lesions will have a final PK blood sample collected approximately 12 hours after their Day 14 evening application and just prior to the initiation of the CST.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study to evaluate adrenal suppression potential and pharmacokinetics of halobetasol lotion 0.05%
| Arm | Type | Receives |
|---|---|---|
| Halobetasol lotion treatment arm | Experimental | Drug: Halobetasol Topical LotionAll subjects will receive Halobetasol Topical Lotion, 0.05%. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subject is male or non-pregnant female and is 12 to 16 years 11 months of age.
- Subject has provided written informed assent and was accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian has provided informed consent for the subject. 3. Subject has a clinical diagnosis of stable plaque psoriasis involving a minimum of 10% body surface area (BSA) within the Treatment Area. The "Treatment Area" is defined as the entire body exclusive of the face, scalp, groin, axillae, and other intertriginous areas.
- 4. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
- 5. Subject is willing and able to apply the test article as directed, comply with study instructions and commit to all follow-up visits for the duration of the study.
- 6. Females must have a negative urine pregnancy test (UPT) at the Screening and Baseline Visits and agree to use an effective form of birth control for the duration of the study.
Key exclusion criteria (18 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 (e.g., Addison's Disease, Cushing's Syndrome) or which exposes the subject to an unacceptable risk by study participation.
- Subject has used any phototherapy (including laser), photochemotherapy or systemic psoriasis therapy including methotrexate, retinoids, cyclosporine or biologics within 30 days prior to the initiation of treatment with the test article.
- Subject has used systemic corticosteroids (including oral or intramuscular) or topical, inhaled or intranasal corticosteroids within 30 or 14 days, respectively, prior to Part B of the Screening Visit and/or the subject has used systemic or topical corticosteroids between Part B of the Screening Visit and the initiation of treatment.
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 LotionAlso: Halobetasol topical lotion 0.05%Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis. | Drug | Halobetasol lotion treatment arm |
Primary outcome
Investigator's Global Assessment
Time frame: Day 15
The IGA score (5-point scale of 0 to 4: 0[clear]; 1[almost clear]; 2[mild]; 3[moderate]; 4[severe]) is an evaluation of the overall severity of a subject's psoriasis in the Treatment Area and takes into consideration the 3 individual characteristics of psoriasis (scaling, erythema, and plaque elevation).
Percent BSA Affected With Disease
Time frame: Day 15
The Percent Body Surface Area (BSA) Affected with Disease was defined as the BSA which was affected with psoriasis within the Treatment Area.
Percent Body Surface Area Treated With Test Article
Time frame: Day 8
The Percent Body Surface Area Treated with Test Article was defined as the BSA which was affected with psoriasis within the Treatment Area that was treated.
Number of Subjects With Abnormal Hypothalamus-Pituitary-Adrenal Axis Response
Time frame: Day 15
An abnormal Hypothalamus-Pituitary-Adrenal (HPA) axis was response was defined as a 30-minute post-stimulation serum cortisol level of ≤18 μg/dL at end of study (EOS)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Stephanie Magajna, MS study chair
Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Halobetasol Topical Lotion in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited at 3 sites in United States.
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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 7 Dec 2021). 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?
Investigator's Global Assessment (time frame: Day 15). The study lists 4 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 7 Dec 2021.