Plaque PsoriasisPhase 4NCT03506477
Enstilar® Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
A Phase 4 study testing Enstilar® foam in people with Plaque Psoriasis and Psoriasis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST IV-VI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis, Psoriasis
- What is being tested?
- Enstilar® foam
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2018to 25 Sep 2019
- 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
- Provide written, signed and dated informed consent prior to initiating any study-related activities.
- Male or female >18 years of age at the time of screening
- Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited to - --African Americans, Asians, Pacific Islanders and Hispanics.
- Clinical diagnosis of chronic plaque-type psoriasis of the body
- Plaque psoriasis with ≥2% Body Surface Area (BSA) involvement (may include scalp involvement), PASI Score ≥ 2, IGA mod 2011 score of 2 or greater (based on scale of 0-4)
- Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. While using investigational product and for at least 28 days after last application of investigational product, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options d
- Must be in general good health as judged by the Investigator, based on medical history and physical examination.
Who cannot join
- Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate, erythrodermic, pustular)
- Diagnosis of other active, ongoing skin diseases or skin infections that may interfere with examination of psoriasis lesions
- Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy. The following washout periods will be required: 2 weeks for topical therapy; 2 weeks for phototherapy; 12 weeks for biologic or targeted therapies; 4 weeks for other systemic therapies
- Use of oral estrogen therapy, excluding oral contraceptive pills
- Women who are pregnant, nursing, or of child-bearing potential who are unwilling to use appropriate method(s) of contraception.
- Patients unwilling to limit exposure to UV light
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- Current significant medical problems that, in the discretion of the investigator, would put the patient at significant risk
- Patients with disorders of calcium metabolism and/or hypercalcemia
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamics half-lives, if known (whichever is longer)
- History of allergy to any component of the IP
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded, Placebo-controlled Study to Evaluate the Tolerability and Efficacy of Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.
Read the detailed description
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints. This condition occurs in different ethnic groups worldwide with varying prevalence.
There are notable differences in psoriasis presentation in skin of color groups. Black patients with psoriasis tend to have less erythema, increased risk of pigmentation, thicker plaques, more scaling, and greater body involvement as compared to white patients. The resolution of psoriasis lesions in darker skin types is associated with a higher rate of dyspigmentation (both hyper- and hypo-pigmentation), which may be more bothersome to patients than the psoriasis itself. Further, several studies have shown that psoriasis is associated with greater psychological impact and worse quality of life in non-whites with psoriasis compared to whites.
Unique issues in skin of color populations make studies dedicated to darker skin types essential for the treatment of psoriasis in these populations. This study will evaluate the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in darker skin types. This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life in skin of color.
- Conditions
- Plaque Psoriasis, Psoriasis
- Being tested
- Enstilar® foam, Vehicle foam
- Keywords
- skin of color, psoriasis, Enstilar, skin diseases
- Medical subject headings
- Psoriasis, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enstilar® foamDrug
Also called Enstilar 0.005%-0.064% Topical Foam
for 4 weeks
Vehicle foamDrug
for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Enstilar® foam | Experimental | Enstilar® foam - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%. Receives: Drug: Enstilar® foam |
| Vehicle foam | Placebo comparator | does not contain the active ingredient Receives: Drug: Vehicle foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Achieved Treatment Success
Number of patients at week 4 who achieved treatment success according to Investigator's Global Assessment (IGA mod 2011) of the entire body including scalp. IGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as IGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or IGA of clear (0) for patients with mild disease at baseline.
Measured: Week 4
Secondary outcomes (10)
Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI)
Number of patients achieving ≥50% improvement and/or ≥75% improvement in PASI at weeks 4 and 8 . PASI combines the assessment of the severity of lesions and the area affected into a single score in the range of 0 (no disease) to 72 (maximal disease)
Measured: 4 weeks, 8 weeks
Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI)
Number of patients achieving ≥50% improvement and/or ≥75% improvement in PSSI at weeks 2, 4 and 8. The Psoriasis Scalp Severity Index (PSSI) assesses severity of scalp disease along the parameters of erythema, induration, and desquamation. The PSSI uses a 5-point scale to grade the three aforementioned clinical parameters. The parameters scores are summed and multiplied by an integer (0-6) that represents the area of affected scalp. The PSSI score ranges from 0 (no disease) to 72 (maximal disease).
Measured: 2 weeks, 4 weeks, 8 weeks
Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)
Number of patients at week 8 who achieved treatment success according to IGA mod 2011 of the entire body including scalp. IGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as IGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or IGA of clear (0) for patients with mild disease at baseline.
Measured: at week 8
Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA)
Number of patients at weeks 4 and 8 who achieved treatment success according to ScIGA. ScIGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as ScIGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or ScIGA of clear (0) for patients with mild disease at baseline.
Measured: 4 weeks, 8 weeks
Patient's Global Assessment of Itch
Patient's Global Assessment of Itch as compared to baseline measured by Visual Analog Scale (VAS). The VAS is a numerical scale used to assess patients' perception of pruritus/itch.The evaluation is a 10cm long line on which the subjects indicate the severity of their pruritus from "0" (no pruritus) to "10" (severe pruritus).
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA)
PaGA have 5 distinct options ranging from (0) "Clear" to (4) "Severe." Number of participants with treatment response defined as clear or almost clear disease (for those with moderate or severe disease at baseline) or clear disease (for those with mild disease at baseline) at 4 weeks and 8 weeks.
Measured: 4 weeks, 8 weeks
Erythema Indices of Target Psoriasis Plaque
A skin spectrophotometer (Mexameter) was used to quantify the degree of erythema of lesional skin compared to an index area (of unaffected skin). The mexameter measures from 0-999. The higher the value for erythema index the more red pigmentation in the skin, this is assessed by quantification of hemoglobin in the skin via reflectance spectroscopy.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Melanin Indices of Target Psoriasis Plaque
A skin spectrophotometer (Mexameter) was used to quantify the melanin index (degree of hyperpigmentation or hypopigmentation) of lesional skin compared to an index area of unaffected skin. The mexameter measures from 0-999. The higher the value for melanin index, the more brown pigment in the skin, this is assessed by quantification of melanin in the skin via reflectance spectroscopy.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Physician Dyspigmentation Visual Analog Scale (VAS)
An investigator performed a visual analog scale (VAS) rating the degree of dyspigmentation of the skin. This VAS ranges from - 5 to 5 as follows: 5 severe dark brown pigmentation (darkest imaginable color), 4 dark brown pigmentation, 3 medium brown pigmentation, 2 light brown pigmentation, 1 slight dark pigmentation (barely perceptible compared to surrounding skin), 0 baseline skin pigmentation, -1 slight hypopigmentation (barely perceptible compared to surrounding skin), -2 mild hypopigmentation (light brown), -3 moderate hypopigmentation (creme-colored skin), -4 severe hypopigmentation (almost complete absence of pigment), -5 depigmentation (complete absence of pigment).
Measured: baseline, 4 weeks, 8 weeks
Mean Change in Dermatology Life Quality Index (DLQI)
DLQI full scale ranges from 0 (no effect at all on patient's life) to 30 (extremely large effect on patients' life). Mean change from Baseline in DLQI at 2, 4, and 8 weeks.
Measured: Baseline, 2 weeks, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start21 May 2018
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- 4:1 Enstilar(R): placebo from baseline to week 4, then open-label Enstilar from weeks 4 to 8.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Alexis, MD, Icahn School of Medicine at Mount Sinai
- Investigators
- Andrew Alexis, MD, MPH, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506477
- Sponsor's protocol ID
- GCO 17-2468
- Other IDs
- HSM# 17-05032
- Status last verified
- Sep 2020
- First submitted
- 17 Apr 2018
- Last updated
- 20 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: With Leo, Pharma.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Placebo-controlled Study to Evaluate the Tolerability and Efficacy of Enstilar® (Calcipotriene and Betamethasone Dipropionate) Foam in the Treatment of Chronic Plaque Psoriasis in Patients With Skin of Color
- ClinicalTrials.gov ID
- NCT03506477
- Acronym / sponsor ID
- GCO 17-2468
- Conditions
- Plaque Psoriasis, Psoriasis
- Keywords
- skin of color, psoriasis, Enstilar, skin diseases
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Posted 20 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a single-center, randomized, double-blinded, vehicle-controlled clinical study to determine the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in skin of color (FST IV-VI). This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques in skin of color (and its change with Enstilar ® treatment) as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life.
Detailed description
Psoriasis is a chronic inflammatory disorder primarily affecting the skin and joints. This condition occurs in different ethnic groups worldwide with varying prevalence.
There are notable differences in psoriasis presentation in skin of color groups. Black patients with psoriasis tend to have less erythema, increased risk of pigmentation, thicker plaques, more scaling, and greater body involvement as compared to white patients. The resolution of psoriasis lesions in darker skin types is associated with a higher rate of dyspigmentation (both hyper- and hypo-pigmentation), which may be more bothersome to patients than the psoriasis itself. Further, several studies have shown that psoriasis is associated with greater psychological impact and worse quality of life in non-whites with psoriasis compared to whites.
Unique issues in skin of color populations make studies dedicated to darker skin types essential for the treatment of psoriasis in these populations. This study will evaluate the efficacy of Enstilar® foam, a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%, in the treatment of psoriasis vulgaris in darker skin types. This study will also evaluate the degree of erythema versus hyperpigmentation in psoriasis plaques as well as the effect of Enstilar ® on post-inflammatory hyperpigmentation and quality of life in skin of color.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 4:1 Enstilar(R): placebo from baseline to week 4, then open-label Enstilar from weeks 4 to 8.
| Arm | Type | Receives |
|---|---|---|
| Enstilar® foam | Experimental | Drug: Enstilar® foamEnstilar® foam - a combination of calcipotriene and betamethasone dipropionate 0.005%/0.064%. |
| Vehicle foam | Placebo comparator | Drug: Vehicle foamdoes not contain the active ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provide written, signed and dated informed consent prior to initiating any study-related activities.
- Male or female >18 years of age at the time of screening
- Fitzpatrick Skin phototype IV-VI, non-white race/ethnicity, including but not limited to - --African Americans, Asians, Pacific Islanders and Hispanics.
- Clinical diagnosis of chronic plaque-type psoriasis of the body
- Plaque psoriasis with ≥2% Body Surface Area (BSA) involvement (may include scalp involvement), PASI Score ≥ 2, IGA mod 2011 score of 2 or greater (based on scale of 0-4)
Key exclusion criteria (10 listed)
- Form of diagnosed psoriasis other than chronic plaque psoriasis (i.e. guttate, erythrodermic, pustular)
- Diagnosis of other active, ongoing skin diseases or skin infections that may interfere with examination of psoriasis lesions
- Ongoing use of other psoriasis treatment including but not limited to topical or systemic corticosteroids, other topical medications (i.e. coal tar), oral or biologic medications for the treatment of psoriasis, and UV therapy. The following washout periods will be required: 2 weeks for topical therapy; 2 weeks for phototherapy; 12 weeks for biologic or targeted therapies; 4 weeks for other systemic therapies
- Use of oral estrogen therapy, excluding oral contraceptive pills
- Women who are pregnant, nursing, or of child-bearing potential who are unwilling to use appropriate method(s) of contraception.
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® foamAlso: Enstilar 0.005%-0.064% Topical Foamfor 4 weeks | Drug | Enstilar® foam |
| Vehicle foamfor 4 weeks | Drug | Vehicle foam |
Primary outcome
Number of Patients Who Achieved Treatment Success
Time frame: Week 4
Number of patients at week 4 who achieved treatment success according to Investigator's Global Assessment (IGA mod 2011) of the entire body including scalp. IGA ranges from 0 (clear) to 4 (severe). Treatment success is defined as IGA of clear (0) or almost clear (1) for patients with ≥ moderate disease at baseline or IGA of clear (0) for patients with mild disease at baseline.
10 secondary outcomes
Number of Participants With Achieving Targeted Psoriasis Area and Severity Index (PASI)
Time frame: 4 weeks, 8 weeks
Number of Patients Achieving Targeted Psoriasis Scalp Severity Index (PSSI)
Time frame: 2 weeks, 4 weeks, 8 weeks
Number of Patients With Treatment Success According to Investigator Global Assessment (IGA Mod 2011)
Time frame: at week 8
Number of Participants Who Achieved Treatment Success According to Scalp Investigator Global Assessment (ScIGA)
Time frame: 4 weeks, 8 weeks
Patient's Global Assessment of Itch
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Number of Participants Who Clear or Almost Clear Disease According to the Patient's Global Assessment of Disease Severity (PaGA)
Time frame: 4 weeks, 8 weeks
Erythema Indices of Target Psoriasis Plaque
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Melanin Indices of Target Psoriasis Plaque
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Physician Dyspigmentation Visual Analog Scale (VAS)
Time frame: baseline, 4 weeks, 8 weeks
Mean Change in Dermatology Life Quality Index (DLQI)
Time frame: Baseline, 2 weeks, 4 weeks, 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. With Leo, Pharma.
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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.
Andrew Alexis, MD, MPH principal investigator
Icahn School of Medicine at Mount Sinai
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® foam in people with Plaque Psoriasis and Psoriasis, run by Icahn School of Medicine at Mount Sinai 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 10 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 20 Jan 2021. 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. Some participants in this study may receive a placebo. 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 20 Jan 2021). 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?
Number of Patients Who Achieved Treatment Success (time frame: 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 20 Jan 2021.