Plaque PsoriasisPhase 4NCT02340169
Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
A Phase 4 study testing Topicort® (desoximetasone) Topical Spray, 0.25% in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site in United States.
Trial summary
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Topicort® (desoximetasone) Topical Spray, 0.25%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2015to 22 Nov 2021
- 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
- Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
- Physicians Global Assessment score of 3 or 4 at baseline
Who cannot join
- Has other dermatological conditions that may interfere with clinical assessments
- Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
- History of an adverse reaction to Cortrosyn™ or similar test reagents
- Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Taro Pharmaceuticals USA Inc.
Hawthorne, New York, 10532
About this study
Official title: An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
Read the detailed description
An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.
- Conditions
- Plaque Psoriasis
- Being tested
- Topicort® (desoximetasone) Topical Spray, 0.25%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topicort® (desoximetasone) Topical Spray, 0.25%Drug
Also called desoximetasone
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Topicort® Topical Spray, 0.25% | Experimental | Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days Receives: Drug: Topicort® (desoximetasone) Topical Spray, 0.25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria:
- their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (< basal + 7)
- the post stimulation level is ≤ 18 mcg/100 ml
Measured: 28 days
Secondary outcomes (2)
Adverse Event
The total number of subjects experiencing adverse events.
Measured: 28 days
Cpre-ss
Concentration prior to dosing at steady state.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2015 (estimated)
- Study start23 Jan 2015
- Primary completion22 Nov 2019
- Study completion22 Nov 2021
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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novum Pharmaceutical Research Services, Study chair, http://www.novumprs.com/contact
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02340169
- Sponsor's protocol ID
- DSXS-1303
- Status last verified
- Feb 2023
- First submitted
- 28 Dec 2014
- Last updated
- 28 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Safety Study to Assess the Potential for Adrenal Suppression and Pharmacokinetics Following Maximal Use Treatment With Topicort® (Desoximetasone) Topical Spray, 0.25% in Pediatric Patients With Plaque Psoriasis.
- ClinicalTrials.gov ID
- NCT02340169
- Acronym / sponsor ID
- DSXS-1303
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Sun Pharmaceutical Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jan 2015 (actual)
- Primary completion
- 22 Nov 2019 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 16 Jan 2015 (estimated)
- Results
- Posted 28 Mar 2023
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 study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
Detailed description
An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topicort® Topical Spray, 0.25% | Experimental | Drug: Topicort® (desoximetasone) Topical Spray, 0.25%Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
- Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
- Physicians Global Assessment score of 3 or 4 at baseline
Key exclusion criteria (4 listed)
- Has other dermatological conditions that may interfere with clinical assessments
- Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
- History of an adverse reaction to Cortrosyn™ or similar test reagents
- Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation
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 |
|---|---|---|
| Topicort® (desoximetasone) Topical Spray, 0.25%Also: desoximetasoneTopicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days | Drug | Topicort® Topical Spray, 0.25% |
Primary outcome
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test
Time frame: 28 days
A patient will be considered to have potential HPA axis suppression if they meet at least one of the criteria: * their 30 minute post injection cortisol level is not at least 7 mcg/100 ml greater than the basal level (< basal + 7) * the post stimulation level is ≤ 18 mcg/100 ml
2 secondary outcomes
Adverse Event
Time frame: 28 days
Cpre-ss
Time frame: 28 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- 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.
Novum Pharmaceutical Research Services study chair
http://www.novumprs.com/contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topicort® (desoximetasone) Topical Spray, 0.25% in people with Plaque Psoriasis, run by Sun Pharmaceutical Industries, Inc. at 1 site 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 3 inclusion and 4 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 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 28 Mar 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?
The Number of Participants With Hypothalmic Pituitary Adrenal Axis Function Suppression as Measured by Cortisol Response Test (time frame: 28 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 28 Mar 2023.