PsoriasisPhase 4NCT04555707
The Maintenance Effect of Enstilar Foam in Combination With Otezla
A Phase 4 study testing Apremilast 30mg and calcipotriene and betamethasone dipropionate in people with Psoriasis, run by Derm Research, PLLC at 1 site in United States.
Trial summary
This is a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat 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?
- Apremilast 30mg and calcipotriene and betamethasone dipropionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2020to 30 Sep 2021
- 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
- Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT result at within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study;
- A female is considered of childbearing potential unless she is:
- postmenopausal > 5Y, without a uterus and/or both ovaries; or has been surgically sterile for > 6M.
- Reliable methods of contraception are:
- hormonal methods or IUD in use > 90d prior to study drug administration, barrier methods plus spermicide in use > 14d prior, or vasectomized partner.
- [Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.]
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- Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days
- Physician Global Assessment (PGA) score of 3
- Able to understand study requirements and sign Informed Consent/HIPAA forms
Who cannot join
- Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study
- History of hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease
- Patients with guttate, erythrodermic, or pustular psoriasis
- Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
- Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis
- Known hypersensitivity to Enstilar Foam or any of its components
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- Current drug or alcohol abuse (Investigator opinion.)
- Subject unable to commit to all the assessments required by the protocol
- Current enrollment in another clinical study and treatment with another experimental drug or approved therapy for experimental use within 30 days prior to the Screening Visit.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Skin Sciences, PLLC
Louisville, Kentucky, 40217
Senen Pena Oliva, MSN, 502-451-9000, spdermresearch@yahoo.com
About this study
This is a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat psoriasis.
Read the detailed description
Approximately 30 subjects will be enrolled in a single-center, open-label study of the treatment of psoriasis. There will be a screening/baseline, week 4, week 16 and week 20 visits. Subjects will include those who have been started on commercial Otezla within the last 10 days of baseline. We will add Enstilar foam QD at baseline visit for 4 weeks. Those subjects who achieve clear or almost clear on PGA scale at week 4 will continue on maintenance dose of Enstilar twice weekly on Mondays and Thursdays QD for the next 12 weeks and they will also continue on Otezla. Subjects will continue to week 20 after stopping Enstilar at week 16..
- Conditions
- Psoriasis
- Being tested
- Apremilast 30mg, calcipotriene and betamethasone dipropionate
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apremilast 30mgDrug
Also called Otezla
30mg PO BID started within 10 days of baseline
calcipotriene and betamethasone dipropionateDrug
Also called Enstilar
1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.
| Study group | Role | What they receive |
|---|---|---|
| Otezla + Enstilar | Experimental | Not described Receives: Drug: Apremilast 30mg; Drug: calcipotriene and betamethasone dipropionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Measured: 4 weeks
Secondary outcomes (7)
Percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Physicians Global Assessment
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Measured: week 4, week 16, week 20
The percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Patient Global Assessment
Patient's Global Assessment of Disease Severity. 0=Clear, 1=Very mild, 2=Mild, 3=Moderate, 4=Severe
Measured: week 4, week 16, week 20
Percent of subjects who achieve PASI (psoriasis area and severity index) 75 at week 4
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
Measured: 4 weeks
Percent of subjects who achieve PASI 75 at week 16
The Psoriasis Area and Severity Index (PASI) is a quantitative rating score for measuring the severity of psoriatic lesions based on area coverage and plaque appearance. PASI 75 evaluates if the subject had a 75% or more reduction in their PASI score from baseline.
Measured: 16 weeks
DLQI (dermatology life quality index) at week 4
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale:
Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: 4 weeks
DLQI at week 16
The Dermatology Life Quality Index (DLQI) is a ten-question questionnaire used to measure the impact of skin disease on the quality of life of an affected person. Each question is scored on a four-point Likert scale:
Very much = 3, A lot = 2, A little = 1, Not at all = 0, Not relevant = 0, Question unanswered = 0. The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: 16 weeks
Itch VAS (visual analogue scale) at week 4 and week 16
The VAS is a scale consisting of a 10cm long line and a single question used for measuring itch intensity. The left end point represents "no itch" and the right end point the "worst imaginable itch".
Measured: 4 week, 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start24 Jun 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Derm Research, PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- L.H. Kircik, M.D., Principal investigator, Skin Sciences, PLLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555707
- Sponsor's protocol ID
- ENS-2001
- Status last verified
- Oct 2020
- First submitted
- 14 Sep 2020
- Last updated
- 9 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Maintenance Effect of Enstilar Foam in Combination With Otezla
- ClinicalTrials.gov ID
- NCT04555707
- Acronym / sponsor ID
- ENS-2001
- Conditions
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Derm Research, PLLCUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 21 Sep 2020 (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 a single-center, open-label study. Approximately 30 qualified subjects will be enrolled in a study lasting 20 weeks which investigates the effect of Enstilar used in combination with Otezla to treat psoriasis.
Detailed description
Approximately 30 subjects will be enrolled in a single-center, open-label study of the treatment of psoriasis. There will be a screening/baseline, week 4, week 16 and week 20 visits. Subjects will include those who have been started on commercial Otezla within the last 10 days of baseline. We will add Enstilar foam QD at baseline visit for 4 weeks. Those subjects who achieve clear or almost clear on PGA scale at week 4 will continue on maintenance dose of Enstilar twice weekly on Mondays and Thursdays QD for the next 12 weeks and they will also continue on Otezla. Subjects will continue to week 20 after stopping Enstilar at week 16..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Otezla + Enstilar | Experimental | Drug: Apremilast 30mg, Drug: calcipotriene and betamethasone dipropionate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-)UPT result at within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study;
- [Exception: Female subjects of CBP who are not sexually active are not required to practice a reliable method of contraception and may be enrolled at the Investigator's discretion provided they are counseled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.]
- Subjects with moderate plaque type psoriasis who have been started on commercial Otezla within the last 10 days
- Physician Global Assessment (PGA) score of 3
- Able to understand study requirements and sign Informed Consent/HIPAA forms
Key exclusion criteria (9 listed)
- Female subjects who are pregnant, breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control, or male subjects planning a pregnancy with their spouse or partner while in the study
- History of hypercalcemia or Vitamin D toxicity or history of significant renal or hepatic disease
- Patients with guttate, erythrodermic, or pustular psoriasis
- Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
- Skin conditions (e.g. eczema) that may interfere with evaluations of psoriasis
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 |
|---|---|---|
| Apremilast 30mgAlso: Otezla30mg PO BID started within 10 days of baseline | Drug | Otezla + Enstilar |
| calcipotriene and betamethasone dipropionateAlso: Enstilar1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20. | Drug | Otezla + Enstilar |
Primary outcome
Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4
Time frame: 4 weeks
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
7 secondary outcomes
Percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Physicians Global Assessment
Time frame: week 4, week 16, week 20
The percent of subjects who are clear or almost clear at week 4, 16 and week 20 on Patient Global Assessment
Time frame: week 4, week 16, week 20
Percent of subjects who achieve PASI (psoriasis area and severity index) 75 at week 4
Time frame: 4 weeks
Percent of subjects who achieve PASI 75 at week 16
Time frame: 16 weeks
DLQI (dermatology life quality index) at week 4
Time frame: 4 weeks
DLQI at week 16
Time frame: 16 weeks
Itch VAS (visual analogue scale) at week 4 and week 16
Time frame: 4 week, 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
- 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.
L.H. Kircik, M.D. principal investigator
Skin Sciences, PLLC
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 Apremilast 30mg and calcipotriene and betamethasone dipropionate in people with Psoriasis, run by Derm Research, PLLC 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 9 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: status not confirmed, as of the sponsor's last update on 9 Oct 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Senen Pena Oliva (502-451-9000, spdermresearch@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of subjects who are clear or almost clear on Physicians Global Assessment at Week 4 (time frame: 4 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 Oct 2020.