Plaque PsoriasisPhase 4NCT03848871
The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
A Phase 4 study testing Enstilar in people with Plaque Psoriasis, run by Derm Research, PLLC at 1 site in United States.
Trial summary
This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment of patients with moderate plaque type psoriasis. Subjects will receive study treatment of Enstilar foam. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Enstilar
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2017to 10 Dec 2018
- 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
- Healthy volunteers accepted
- 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 (-) urine pregnancy test (UPT) result 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 >5 years, without a uterus and/or both ovaries, or has been surgically sterile for >6 months
- Reliable methods of contraception are:
- hormonal methods or intrauterine device (IUD) in use > 90 days prior to study drug administration, barrier methods plus spermicide in use > 14 days prior, or vasectomized partner.
- [Exception: Female subjects of child bearing potential (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 counselled 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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- Moderate plaque type psoriasis eligible for topical therapies.
- Patients with a minimum of 3% BSA to a maximum of 20% BSA \& bilateral symmetric psoriatic plaques of 2 to 4 cm in diameter.
- 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 hypercalcaemia or vitamin D toxicity.
- Patients with guttate, erythrodermic, or pustular psoriasis
- Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
- Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar, salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks of baseline.
- Use of any biologics within 3 months of baseline.
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- Use of other systemic psoriasis treatments (ie, oral retinoids, methotrexate, cyclosporine, or other immunomodulators) within 4 weeks of baseline.
- Use of ultraviolet B rays (UVB) or psoralen+ultraviolet a rays (PUVA) within 2 weeks of baseline.
- Skin conditions (e.g. eczema) other than psoriasis that may interfere with evaluations of psoriasis.
- Known hypersensitivity to Enstilar or any of its components.
- Contraindications according to Enstilar.
- Current drug or alcohol abuse (Investigator opinion.)
- Subject unable to commit to all the assessments required by protocol. -
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment of patients with moderate plaque type psoriasis. Subjects will receive study treatment of Enstilar foam.
Read the detailed description
Approximately 20 subjects from 3 sites will be enrolled in this open-label study. Subjects will receive Enstilar foam and all adverse events and concomitant medications will be recorded.
Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis and bilateral symmetric psoriatic plaques will have a target lesion identified on knees or elbows and subjects will receive study treatment as outlined above.
Enstilar will be initiated daily for the entire study period of four weeks. Study visits will occur as follows: screening/baseline, week 2, week 4. Study assessments at each visit will be Body Surface Area (BSA,) Physicians Global Assessment (PGA,) Target lesion size, Total Lesion Severity Score (TLSS) and standard medical assessments. There will be standard medication/treatment and washout periods.
NOTE: The original study protocol dated december 20, 2017, was designed to compare the effect of Enstilar versus vehicle for the treatment of plaque psoriasis at a 1:1 ratio. A protocol amendment on March 20, 2018 eliminated the chance of placebo and made this an open-label study of the effects of Enstilar for the treatment of plaque psoriasis.
- Conditions
- Plaque Psoriasis
- Being tested
- Enstilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnstilarDrug
Also called calcipotriene and betamethasone dipropionate
Enstilar foam applied to affected area once daily
| Study group | Role | What they receive |
|---|---|---|
| Enstilar foam | Experimental | Subjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4. Receives: Drug: Enstilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
Measured: screening/baseline, week 2, week 4
Secondary outcomes (5)
Change in Lesion Size From Baseline to Week 2 and Week 4
Size of target lesion recorded as height in cm x length in cm
Measured: screening/baseline, week 2, week 4
Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
Percent of total body surface affected by psoriasis, calculated by multiplying the percent of a specified body area affected by psoriasis x the percent of total body surface area represented by the specified area (where head = 10% of total body surface, trunk = 30%, upper limbs = 20%, lower limbs = 40%)
Measured: screening/baseline, week 2, week 4
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 1= slightly pink, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion
Measured: screening/baseline, week 2, week 4
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 1=very slight, 2=slight definite elevation above normal skin level, 3=mild, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion
Measured: screening/baseline, week 2, week 4
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
A combined score of disease severity of target lesion which includes assessment of erythema (0=none, 2=pink, 4=red, 6=very red, 8=extremely red), induration (0=no evidence of plaque above normal skin level, 2=slight definite elevation above normal skin level, 4=moderate elevation with rounded or sloped edges to plaque, 6=marked elevation with hard sharp edges to plaque, 8=very marked elevation with very hard sharp edges to plaque), and scaling (0=no evidence of scaling on lesion, 2= mild mainly fine scales with some of lesion at least partially covered, 4=moderate somewhat coarser scale and most of lesion at least partially covered, 6= severe coarse thick scales and rough surface covering virtually all of lesion, 8=very severe coarse very thick scales and rough surface covering entire lesion)
Measured: screening/baseline, week 2, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start12 Dec 2017
- Primary completion30 Nov 2018
- Study completion10 Dec 2018
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derm Research, PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03848871
- Sponsor's protocol ID
- ENS-1702
- Status last verified
- Aug 2020
- First submitted
- 6 Feb 2019
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Enstilar Versus Vehicle on Target Lesions in Moderate Plaque Type Psoriasis Patients
- ClinicalTrials.gov ID
- NCT03848871
- Acronym / sponsor ID
- ENS-1702
- Conditions
- Plaque Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Derm Research, PLLCUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to show whether there is a benefit of prescribing Enstilar in the treatment of patients with moderate plaque type psoriasis. Subjects will receive study treatment of Enstilar foam.
Detailed description
Approximately 20 subjects from 3 sites will be enrolled in this open-label study. Subjects will receive Enstilar foam and all adverse events and concomitant medications will be recorded.
Subjects will attend a screening visit/baseline visit and those with plaque-type psoriasis and bilateral symmetric psoriatic plaques will have a target lesion identified on knees or elbows and subjects will receive study treatment as outlined above.
Enstilar will be initiated daily for the entire study period of four weeks. Study visits will occur as follows: screening/baseline, week 2, week 4. Study assessments at each visit will be Body Surface Area (BSA,) Physicians Global Assessment (PGA,) Target lesion size, Total Lesion Severity Score (TLSS) and standard medical assessments. There will be standard medication/treatment and washout periods.
NOTE: The original study protocol dated december 20, 2017, was designed to compare the effect of Enstilar versus vehicle for the treatment of plaque psoriasis at a 1:1 ratio. A protocol amendment on March 20, 2018 eliminated the chance of placebo and made this an open-label study of the effects of Enstilar for the treatment of plaque psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enstilar foam | Experimental | Drug: EnstilarSubjects will receive calcipotriene hydrate/betamethasone dipropionate (Enstilar) foam and apply to affected areas once daily. A target lesion located on elbow or knee will be identified by the Investigator for daily treatment with the medicated foam from Baseline through week 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Outpatient, male or female subjects of any race, 18 years of age or higher. Female subjects of childbearing potential must have a (-) urine pregnancy test (UPT) result within 7 days of the first dose of study drug and practice a reliable method of contraception throughout the study.
- [Exception: Female subjects of child bearing potential (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 counselled to remain sexually inactive for the duration of the study and understand the risks involved in getting pregnant during the study.]
- Moderate plaque type psoriasis eligible for topical therapies.
- Patients with a minimum of 3% BSA to a maximum of 20% BSA \& bilateral symmetric psoriatic plaques of 2 to 4 cm in diameter.
- Physician Global Assessment (PGA) score of 3.
Key exclusion criteria (13 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 hypercalcaemia or vitamin D toxicity.
- Patients with guttate, erythrodermic, or pustular psoriasis
- Serious skin condition (other than psoriasis) or uncontrolled medical condition (in the opinion of the investigator.)
- Topical steroids, topical immunomodulators, topical vitamin D derivatives, tar, salicylic acid, anthralin or any other topical treatment for psoriasis within 2 weeks of baseline.
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 |
|---|---|---|
| EnstilarAlso: calcipotriene and betamethasone dipropionateEnstilar foam applied to affected area once daily | Drug | Enstilar foam |
Primary outcome
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4
Time frame: screening/baseline, week 2, week 4
Physician assessment of disease severity. 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate
5 secondary outcomes
Change in Lesion Size From Baseline to Week 2 and Week 4
Time frame: screening/baseline, week 2, week 4
Change in Body Surface Area (BSA) From Baseline to Week 2 and Week 4
Time frame: screening/baseline, week 2, week 4
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Erythema
Time frame: screening/baseline, week 2, week 4
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Induration
Time frame: screening/baseline, week 2, week 4
Change in TLSS (Total Lesion Severity Score) From Baseline to Week 2 and Week 4 - Assessment of Scaling
Time frame: screening/baseline, week 2, week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 in people with Plaque 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 11 inclusion and 13 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 26 Aug 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?
Yes. Results are posted in the registry (first posted 26 Aug 2020). 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?
Change in Physicians Global Assessment (PGA) From Baseline to Week 2 and Week 4 (time frame: screening/baseline, week 2, week 4). 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 26 Aug 2020.