PsoriasisPhase 4NCT03080545
Enstilar in Combination With Biologic Agents
A Phase 4 study testing Enstilar 0.005%-0.064% Topical Foam in people with Psoriasis, run by Psoriasis Treatment Center of Central New Jersey at 1 site in United States.
Trial summary
Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis
- What is being tested?
- Enstilar 0.005%-0.064% Topical Foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Oct 2017
- Phase
- Phase 4
- 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 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 psoriasis.
- Able to give written informed consent prior to performance of any study related procedures.
- Treated with a biologic agent for a minimum of 24 weeks at baseline.
- Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
- 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
- >5% Body Surface Area
- 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).
- Patient used other topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).
Show all 9Show fewer
- Patient received UVB phototherapy within 2 weeks of Baseline.
- Patient received PUVA phototherapy within 4 weeks of Baseline.
- Patient has a known hypersensitivity to the excipients of Enstilar® 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 Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents
Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.
Read the detailed description
A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks
- Conditions
- Psoriasis
- Being tested
- Enstilar 0.005%-0.064% Topical Foam
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enstilar 0.005%-0.064% Topical FoamDrug
Topical foam
| Study group | Role | What they receive |
|---|---|---|
| Open Label Enstilar | Experimental | open label Receives: Drug: Enstilar 0.005%-0.064% Topical Foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy
pga x bsa
Measured: 16 weeks
Secondary outcomes (3)
Physician Global Assessment
PGA
Measured: 16 weeks
Body Surface area
BSA
Measured: 16 weeks
dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire
satisfaction determined by patient reported outcomes
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 posted15 Mar 2017
- Study start1 May 2017
- Primary completion30 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Psoriasis Treatment Center of Central New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080545
- Sponsor's protocol ID
- PTC01
- Status last verified
- Dec 2017
- First submitted
- 2 Mar 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Study Evaluating Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam, 0.005%/0.064% QD in Psoriasis Patients Being Treated With Biologic Agents
- ClinicalTrials.gov ID
- NCT03080545
- Acronym / sponsor ID
- PTC01
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Psoriasis Treatment Center of Central New JerseyUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 15 Mar 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.
Patients receiving biologic therapy with 5% or less body surface area will receive Enstilar topical foam for 16 weeks.
Detailed description
A two-phase, single center, observational study of 25 subjects to assess 4 weeks of adjunctive therapy of Enstilar® QD followed by 12 weeks QD on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks
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 Enstilar | Experimental | Drug: Enstilar 0.005%-0.064% Topical Foamopen label |
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 psoriasis.
- Able to give written informed consent prior to performance of any study related procedures.
- Treated with a biologic agent for a minimum of 24 weeks at baseline.
- Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
Key exclusion criteria (9 listed)
- >5% Body Surface Area
- 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).
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 |
|---|---|---|
| Enstilar 0.005%-0.064% Topical FoamTopical foam | Drug | Open Label Enstilar |
Primary outcome
Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy
Time frame: 16 weeks
pga x bsa
3 secondary outcomes
Physician Global Assessment
Time frame: 16 weeks
Body Surface area
Time frame: 16 weeks
dermatology life quality index; TSQ-9 Treatment Satisfaction Questionnaire
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- 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.
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 Enstilar 0.005%-0.064% Topical Foam 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 9 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 3 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Physician global assessment multiplied by body surface area improvement after 16 weeks of Enstilar® adjunctive therapy (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 3 Jan 2018; AzTrials last refreshed its copy on 31 Oct 2026.