Atopic DermatitisPhase 2NCT03245385
Multiple-Dose Pharmacokinetics and Potential for Adrenal Suppression Following Treatment With Halobetasol Spray in Patients With Atopic Dermatitis
A Phase 2 study testing Treatment with Halobetasol propionate 0.05% topical spray in people with Atopic Dermatitis, run by Sun Pharmaceutical Industries Limited at 13 sites in United States.
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 atopic dermatitis. Read more about this study
- Who is it for?
- Ages 12 to 70 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Treatment with Halobetasol propionate 0.05% topical spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 13 sitesUnited States
- Study dates
- 24 Jul 2017to 5 Feb 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 moderate to severe atopic dermatitis with ≥ 25% BSA affected (excluding face, scalp, groin, axillae and other intertriginous areas)
Show all 12Show fewer
- Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe).
- Patients in Cohort 2 must weigh a minimum of 26 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.
- Mild atopic dermatitis.
- IGA score < 3.
- Atopic dermatitis with a BSA involvement < 25%.
- Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response:
- Basal (pre CortrosynTM injection) cortisol concentration < 5 mcg/100 mL.
Show all 35Show fewer
- 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.
- Recurrent or active cutaneous bacterial or viral infection in any treatment area at baseline (i.e., clinically infected atopic dermatitis).
- Patient has a history of atopic dermatitis that has been unresponsive to topical corticosteroid therapy.
- Any condition (i.e., sunburn, psoriasis etc.) that, in the Investigator's opinion, may interfere with the clinical assessments of the signs and symptoms of atopic dermatitis.
- 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 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 pharmacokinetic blood sampling.
- 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) topical tacrolimus, 5) topical pimecrolimus, 6) systemic retinoids or 7) any other systemic atopic dermatitis 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 or 2) interferon.
- 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 atopic dermatitis 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 hour before baseline.
- Topical antibiotics in the treatment area within 7 days before baseline.
- Patient has been treated within 6 months before baseline with any biological therapies for atopic dermatitis.
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
L&C Professional Medical Research Institute
Hazleton, Pennsylvania, 18201
Vital Pharma Research
Hialeah, Florida, 33016
Solutions Through Advanced Research
Jacksonville, Florida, 32256
Integrity Research Center
Miami, Florida, 33015
Millennium Clinical Research, INC
Miami, Florida, 33125
Regenerate Clinical Trials, LLC
Miami, Florida, 33155
Life Medical Center and Research, INC
Miami, Florida, 33166
Vista Health Research
Miami, Florida, 33176
Montana Medical Research/Elias Research Assoc.
Missoula, Montana, 49808
Providence Clinical Research
North Hollywood, California, 91606
Havana Research Institute
Pasadena, California, 91105
Sun Research Institute
San Antonio, Texas, 78215
Elias Research
Troy, Michigan, 48085
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 (Sun Pharmaceuticals Industries Limited) in Patients With Moderate to Severe Atopic Dermatitis
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 atopic dermatitis. At least 40 eligible patients with atopic dermatitis 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 atopic dermatitis. At least 40 eligible patients with atopic dermatitis 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 atopic dermatitis 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 ≥ 25% BSA affected.
Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% 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. 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, as defined in study protocol. Patients enrolled in the study will apply the study product twice daily onto the affected skin areas for 14 days (Days 1-14), according to provided instructions. .Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses of study product. All patients will attend the clinic for the following 8 scheduled visits. Patients will apply the morning dose of the study product in the clinic at each clinic visit (and evening dose on Day 4) 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. All patients will have a cortisol response test performed at screening and on Day 17 (at least 48 hours after last dose of study product).
The safety profile of the test product will be evaluated by analysis of reported adverse events.
- Conditions
- Atopic Dermatitis
- Being tested
- Treatment with Halobetasol propionate 0.05% topical spray
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with Halobetasol propionate 0.05% topical sprayDrug
Patients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g
| Study group | Role | What they receive |
|---|---|---|
| Treatment with topical halobetasol spray 0.05% | Experimental | Patients 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: Treatment with Halobetasol propionate 0.05% topical spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the IGA score at Days 4, 5, 7 and 14.
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 (almost clear).
Measured: 14 days
Secondary outcomes (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: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start24 Jul 2017
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Why it stopped: Sponsors decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single treatment arm study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Responsible party
- Sponsor
- Investigators
- Rajinder K Jalali, MD, Study director, Sun Pharmaceutical Industries Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245385
- Sponsor's protocol ID
- 71542613
- Status last verified
- Sep 2019
- First submitted
- 5 Aug 2017
- Last updated
- 25 Sep 2019
- Results posted
- No
- 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 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 (Sun Pharmaceuticals Industries Limited) in Patients With Moderate to Severe Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT03245385
- Acronym / sponsor ID
- 71542613
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsors decision
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Novum Pharmaceutical Research Services
- Study start
- 24 Jul 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 atopic dermatitis. At least 40 eligible patients with atopic dermatitis that satisfy all eligibility criteria will be enrolled into the study
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 atopic dermatitis. At least 40 eligible patients with atopic dermatitis 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 atopic dermatitis 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 ≥ 25% BSA affected.
Cohort 2: At least 20 patients 12-16 years and 11 months of age with ≥ 25% 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. 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, as defined in study protocol. Patients enrolled in the study will apply the study product twice daily onto the affected skin areas for 14 days (Days 1-14), according to provided instructions. .Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses of study product. All patients will attend the clinic for the following 8 scheduled visits. Patients will apply the morning dose of the study product in the clinic at each clinic visit (and evening dose on Day 4) 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. All patients will have a cortisol response test performed at screening and on Day 17 (at least 48 hours after last dose of study product).
The safety profile of the test product will be evaluated by analysis of reported adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single treatment arm study
| Arm | Type | Receives |
|---|---|---|
| Treatment with topical halobetasol spray 0.05% | Experimental | Drug: Treatment with Halobetasol propionate 0.05% topical sprayPatients will instructed o apply halobetasol spray twice daily for 14 days and not to rub over the affected area after application of spray. |
Who may qualify
- Ages
- 12 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- Males or non-pregnant, non-lactating females:
- 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 moderate to severe atopic dermatitis with ≥ 25% BSA affected (excluding face, scalp, groin, axillae and other intertriginous areas)
- Investigator Global Assessment (IGA) score of 3 (Moderate) or 4 (Severe).
Key exclusion criteria (35 listed)
- 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.
- Mild atopic dermatitis.
- IGA score < 3.
- Atopic dermatitis with a BSA involvement < 25%.
- Results from a cortisol response test that show evidence of any abnormal HPA function or adrenal response:
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 |
|---|---|---|
| Treatment with Halobetasol propionate 0.05% topical sprayPatients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g | Drug | Treatment with topical halobetasol spray 0.05% |
Primary outcome
Change from baseline in the IGA score at Days 4, 5, 7 and 14.
Time frame: 14 days
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 (almost clear).
1 secondary outcome
Hypothalamic Pituitary Adrenal (HPA) Axis suppression
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Sponsors decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
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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.
Rajinder K Jalali, MD study director
Sun Pharmaceutical Industries Limited
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment with Halobetasol propionate 0.05% topical spray in people with Atopic Dermatitis, run by Sun Pharmaceutical Industries Limited at 13 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 12 inclusion and 35 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 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 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 stopped early (reason given: Sponsors decision). Results are not available in the source record.
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 Days 4, 5, 7 and 14. (time frame: 14 days). 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 25 Sep 2019.