PsoriasisPhase 4NCT02985736
Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray
A Phase 4 study testing Topicort Topical Spray in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Topicort Topical Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 27 Jan 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female adults ≥ 18 years of age.
- Diagnosis of chronic plaque-type scalp psoriasis.
- IGA of mild or greater (scalp only) determined at screening
- Scalp surface area of 30% or greater determined at screening
- Able to give written informed consent prior to performance of any study related procedures.
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom, diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.
Who cannot join
- <30% scalp surface area
- Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
- Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Pregnant or breast feeding, or considering becoming pregnant during the study.
- Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).
Show all 11Show fewer
- Use of ustekinumab and/or anti-IL-17 (interleukin 17) biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.
- Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (not including permitted topical therapy for face, groin and axilla).
- Patient received ultraviolet B, UVB phototherapy within 2 weeks of Baseline.
- Patient received psoralen and Ultraviolet A, PUVA phototherapy within 4 weeks of Baseline.
- Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
Trial locations and contacts
1 site in 1 country.
United States1 site
Psoriasis Treatment Center of Central New Jersey
East Windsor, New Jersey, 08520
About this study
Official title: An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis
Read the detailed description
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)
- Conditions
- Psoriasis
- Being tested
- Topicort Topical Spray
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topicort Topical SprayDrug
| Study group | Role | What they receive |
|---|---|---|
| open label | Experimental | Not described Receives: Drug: Topicort Topical Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator Global Assessment (Scalp Only)
Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startSep 2016
- Primary completion27 Jan 2017
- Study completion27 Jan 2017
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 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Pharmaceutical Industries, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985736
- Sponsor's protocol ID
- JB-02
- Status last verified
- Mar 2024
- First submitted
- 5 Oct 2016
- Last updated
- 9 Apr 2024
- 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 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Study Evaluating Topicort® Topical Spray 0.25% (Desoximetasone) in Patients With Scalp Psoriasis
- ClinicalTrials.gov ID
- NCT02985736
- Acronym / sponsor ID
- JB-02
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- Sun Pharmaceutical Industries, Inc.
- Study start
- Sep 2016
- Primary completion
- 27 Jan 2017 (actual)
- Study completion
- 27 Jan 2017 (actual)
- First posted
- 7 Dec 2016 (estimated)
- Results
- Posted 9 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center, study of 20 subjects to assess 4 weeks of therapy with Topicort® twice daily BID and 12 weeks twice daily on 2 consecutive days to patients with scalp psoriasis
Detailed description
All patients will receive Topicort® twcie daily (BID) for 4 weeks. After week 4 patients will receive Topicort® twice weekly (on consecutive days) for 12 weeks, Patients will treat other body areas affected by plaque psoriasis with Topicort® during the study period (excludes face, groin, axilla)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Experimental | Drug: Topicort Topical Spray |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female adults ≥ 18 years of age.
- Diagnosis of chronic plaque-type scalp psoriasis.
- IGA of mild or greater (scalp only) determined at screening
- Scalp surface area of 30% or greater determined at screening
- Able to give written informed consent prior to performance of any study related procedures.
Key exclusion criteria (11 listed)
- <30% scalp surface area
- Scalp Investigator global assessment (IGA) clear or almost clear at time of screening
- Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Pregnant or breast feeding, or considering becoming pregnant during the study.
- Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
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 Topical Spray | Drug | open label |
Primary outcome
Investigator Global Assessment (Scalp Only)
Time frame: 16 weeks
Scalp psoriasis severity scale (score 0-4 where 0 is no psoriasis and 4 is severe)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Psoriasis
RecruitingObservational study
Treatment Effectiveness in People With axSpA or PsA Starting Treatment With Bimekizumab, Risankizumab, Guselkumab, Upadacitinib, or a TNF Inhibitor
Axial Spondylarthritis (axSpA), Psoriatic Arthritis (PsA)
Not yet recruitingPhase 3
Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis.
Psoriasis, Psoriasis Genital
RecruitingObservational study
PsoBest - The German Psoriasis Registry
Psoriasis, Psoriatic-arthritis
RecruitingPhase 1
A Clinical Trial of MK-8644 in Healthy Participants and Participants With Psoriasis (MK-8644-001)
Psoriasis, Healthy
Not yet recruitingPhase 3
A Study of Zasocitinib in Adults With Psoriatic Arthritis (LATITUDE PsA NeXt)
Psoriatic Arthritis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Topical Spray in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey 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 7 inclusion and 11 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 9 Apr 2024. 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 9 Apr 2024). 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 Global Assessment (Scalp Only) (time frame: 16 weeks). 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 9 Apr 2024.