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Plaque PsoriasisPhase 2NCT03298581

Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Plaque Psoriasis

A Phase 2 study testing Halobetasol Propionate in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis. Read more about this study

Who is it for?
Ages 12 to 70 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Halobetasol Propionate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Jan 2017to 31 Jan 2018
Phase
Phase 2
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Males or non-pregnant, non-lactating females:
  • Cohort 1: 18 years of age and older
  • Cohort 2: 12-16 years and 11 months of age (Cohort 2 will not begin enrollment until review and approval of safety information from Cohort 1.)
  • If female and of childbearing potential, prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g., condom, IUD, oral, transdermal or injected hormonal contraceptives). Female patients using hormonal contraceptives should have been on the same product/dosing regimen for at least 28 days before baseline and should not change this regimen during the study.
  • Signed informed consent form that meets all criteria of current FDA regulations. For a patient considered to be a minor in the state he/she lives and is enrolled, the parent or legal guardian will be required to sign the consent form and the patient will sign an IRB approved "assent to participate" form. Approved informed consent and assent forms specific to each cohort will be required.
  • Patients with a definite clinical diagnosis of stable plaque psoriasis with:
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  • Cohort 1: 18 years of age and older with ≥ 20% BSA affected (excluding the face, scalp, groin, axillae and other intertriginous areas)
  • Cohort 2: 12-16 years and 11 months of age with ≥ 10% BSA affected (excluding the face, scalp, groin, axillae and other intertriginous areas)
  • Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe).
  • Patients in Cohort 2 must weigh a minimum of 24 kg.
  • Results from a cortisol response test that are considered normal and show no evidence of any abnormal HPA function or adrenal response. Patients must fulfill all of the following stipulations:
  • Basal (pre-Cortrosyn™ injection) cortisol concentration ≥ 5 mcg/100 mL.
  • 30-minute post-injection cortisol level is at least 7 mcg/100 mL greater than the basal level (≥ basal value + 7).
  • Post-stimulation level > 18 mcg/100 mL.

Who cannot join

  • Females who are pregnant, nursing, planning to become pregnant during the duration of the study, or if of childbearing potential and sexually active and not prepared to use appropriate contraceptive methods to avoid pregnancy.
  • Lacks stable diagnosis of plaque psoriasis or has been diagnosed with mild plaque psoriasis.
  • IGA score < 3.
  • Plaque psoriasis with a BSA involvement < 20% for Cohort 1 or < 10% for Cohort 2.
  • Current diagnosis of types of psoriasis other than stable plaque psoriasis (i.e., erythrodermic, exfolative or pustular psoriasis).
  • Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response:
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  • Basal (pre-CortrosynTM injection) cortisol concentration < 5 mcg/100 mL.
  • 30-minute post-injection cortisol level is less than 7 mcg/100 mL greater than the basal level (< basal value + 7).
  • Post-stimulation level ≤ 18 mcg/100 mL.
  • Patient has a history of plaque psoriasis that has been unresponsive to topical corticosteroid therapy.
  • Any condition (i.e., sunburn, atopic or contact dermatitis, etc.) that, in the Investigator's opinion, may interfere with the clinical assessments of the signs and symptoms of plaque psoriasis.
  • History of prolonged bleeding or a past diagnosis of bleeding disorders and/or history of blood loss exceeding 450 mL (including blood donations) within 1 month before the study.
  • Patient with poor peripheral venous access.
  • History of mastectomy or lymphatic insufficiency of the upper limb (patient is eligible if blood can be taken from the arm opposite the site of surgery or condition).
  • History of allergy or sensitivity to corticosteroids or history of any drug hypersensitivity or intolerance that in the opinion of the Investigator, would compromise the safety of the patient or the results of the study.
  • Patient has a significant history or current evidence of chronic infectious disease, system disorder, Netherton's Syndrome, uncontrolled diabetes, organ disorder or insufficiency, immunosuppression (from medical treatment or disease) or other medical condition (including active or recurrent bacterial, viral or fungal infection or open wounds) that, in the Investigator's opinion, would place the study patient at undue risk by participation in the study or as an unsuitable candidate for the study.
  • Patients who have a history of or current diagnosis of glaucoma or posterior subcapsular cataracts or any other ocular condition that, in the opinion of the Investigator, would place study patient at undue risk.
  • Patient is currently receiving or has received any radiation therapy or anti-neoplastic agents within 3 months before baseline.
  • Use within 4 weeks before baseline of 1) oral or intravenous corticosteroids, 2) UVA/UVB therapy, 3) PUVA (psoralen plus ultraviolet A therapy, 4) prescription strength anti-inflammatory agents, 5) topical tacrolimus or pimecrolimus or 6) any other systemic psoriasis treatment.
  • Known history of hypothalamic-pituitary-adrenal axis impairment or any other disturbance of the adrenal function (e.g., Cushing or Addison disease).
  • Use of tanning booths or nonprescription UV light source within 2 weeks before baseline.
  • Use within 8 weeks before baseline of 1) immunomodulators or immunosuppressive therapies, 2) interferon or 3) systemic retinoids.
  • Use within 14 days before baseline of 1) systemic antibiotics, 2) calcipotriene or other Vitamin D preparations, or 3) topical retinoids.
  • Patients who have used topical treatments, prescription or over the counter, including:
  • Any topical anti-psoriatic therapeutic agents of any kind within the 2 weeks before baseline.
  • Any topical corticosteroids within the 2 weeks before baseline.
  • Any antibacterial, medicated and/or astringent washes, soaps, pads or moisturizers within 3 days before baseline.
  • High strength (20% or above) alpha-hydroxy acid or any kind of peel or other procedures (e.g., laser hair removal) within 30 days before baseline.
  • Any topical products (i.e., sunscreens, lotions, creams), except for bland emollient (moisturizer) within 24 hours before baseline.
  • Topical antibiotics in the treatment area within 7 days before baseline.
  • New regimens of beta blockers.
  • Lithium preparations within 2 weeks before baseline.
  • Anti-malarial agents within 2 weeks before baseline.
  • Patient has been treated within 6 months before baseline with any biological therapies for psoriasis.
  • Inability to understand the protocol requirements, instructions, and study related restrictions, the nature, scope, and possible consequences of the clinical study.
  • Unlikely to comply with the protocol requirements, instructions, and study-related restrictions, such as uncooperative attitude, inability to return for follow-up visits, and improbability of completing the clinical study.
  • Receipt of any drug as part of a research study within 30 days before baseline.
  • The patient is a member of the investigational study staff or a member of the family of the investigational study staff.
  • Previous participation in this study.

About this study

Official title: An Open-label Safety Study to Assess the Multiple-dose Pharmacokinetics and Potential for Adrenal Suppression Following Topical Treatment With Halobetasol Propionate 0.05% Topical Spray Applied Twice Daily for 28 Days in Patients With Moderate to Severe Plaque Psoriasis

This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis. At least 40 eligible patients with plaque psoriasis that satisfy all eligibility criteria will be enrolled into the study

Read the detailed description

This is an open-label, safety study designed to assess the multiple-dose pharmacokinetics and potential for adrenal suppression following topical treatment with halobetasol propionate 0.05% spray applied twice-daily in adult patients with moderate to severe plaque psoriasis. At least 40 eligible patients with plaque psoriasis that satisfy all eligibility criteria will be enrolled into the study. Patients must be overall in good health and should have a current diagnosis of moderate to severe plaque psoriasis with Investigator Global Assessment (IGA) score of at least 3 or 4. Patients will be stratified by age with:

Cohort 1: At least 20 patients 18 years of age and older with ≥ 20% body surface area (BSA) affected Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 10% BSA affected Cohort 2 will initiate enrollment once all enrolled patients in Cohort 1 have completed the study and a safety analysis has been reviewed by the Medical Monitor and approved by the Novum Independent Institutional Review Board (NIIRB). Sites will not begin enrollment of patients in Cohort 2 until the site is notified by email that the safety analysis for Cohort 1 has been reviewed and approved. Confirmation of email receipt will be required from each Investigator before enrollment of Cohort 2 can begin. Each cohort will be enrolled based on the availability of patients. Each cohort will be reviewed for the potential of HPA axis suppression. The Medical Monitor or NIIRB may discontinue the study at any time if safety concerns are found. If 6 or more patients in Cohort 1 experience HPA axis suppression, then enrollment for Cohort 1 will be stopped. Cohort 2 will not be initiated if 6 or more patients enrolled in Cohort 1 experience HPA axis suppression or 30% or more of the final enrolled number of patients in Cohort 1 experience HPA axis suppression. If 6 or more patients in Cohort 2 experience HPA axis suppression, then enrollment for Cohort 2 will be stopped. If the study is stopped at any time, patients currently enrolled will be contacted via phone and instructed to discontinue study product immediately. Patients will be instructed to return for their next scheduled visit for cortisol response testing. Sites will follow up with patients and monitor for HPA axis suppression. All patients will be followed until cortisol levels are normal.

Patients will be instructed to apply topical spray twice daily onto the affected skin areas for 28 days. Patients will be instructed not to rub over the affected area after application of spray Patients will apply the morning dose of the study product in the clinic at each clinic visit and at home during non-clinic visits. A phone call will be made approximately 14 days after the patient has completed dosing to follow-up on any new adverse events that may have occurred

Being tested
Halobetasol Propionate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Halobetasol PropionateDrug

    Also called Topical treatment with Halobetasol spray

    Experimental: Treatment with topical halobetasol spray 0.05% Patients will instructed o apply halobetasol spray twice daily for 28 days and not to rub over the affected area after application of spray.

Study groups in NCT03298581
Study groupRoleWhat they receive
Halobetasol propionate spray 0.05%ExperimentalPatients will instructed o apply halobetasol spray twice daily for 14 days and not to rub over the affected area after application of spray.
Receives: Drug: Halobetasol Propionate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in the IGA score at Day 28

    Patients will be considered to have shown improvement in disease severity if the IGA score decreases by at least one unit from the baseline score, and will be considered a treatment success if the IGA score is either 0 (clear) or 1 (minimal).

    Measured: 28 days

Secondary outcomes (1)

  1. Hypothalamic Pituitary Adrenal (HPA) Axis suppression

    Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence, defined by 30 minute post- CortrosynTM injection level cortisol level of ≤18 mcg/100 mL, at the end of treatment.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start1 Jan 2017
  3. Primary completion31 Jan 2018
  4. Study completion31 Jan 2018

Why it stopped: Sponsor decision

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open label, single treatment arm study
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298581
Sponsor's protocol ID
71542610
Status last verified
Jun 2021
First submitted
19 Sep 2017
Last updated
14 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Halobetasol Propionate in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries Limited.

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 14 inclusion and 39 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: withdrawn, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change from baseline in the IGA score at Day 28 (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03298581.

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 14 Jun 2021.

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