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CompletedNCT02983981Updated Mar 20, 2024Results posted

Topical Psoriasis Study for Patients Receiving Biologic Therapy

A Phase 4 interventional study of Topicort Topical Spray in Psoriasis, sponsored by Psoriasis Treatment Center of Central New Jersey. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-20.

Sponsored by Psoriasis Treatment Center of Central New Jersey · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks

Read the detailed description

A two-phase, single center, study of 20 subjects to assess 4 weeks of add-on therapy of Topicort® BID and 12 weeks BID on two consecutive days a week to patients with ≤5% BSA who are receiving biologic therapy for at least 24 weeks.

Adult male and female subjects with moderate to severe chronic plaque psoriasis All patients will receive Topicort® BID for 4 weeks.

After week 4 patients will receive Topicort® BID on two consecutive days a week for 12 weeks.

02

Conditions studied

  • Psoriasis

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 20 is below the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Psoriasis Treatment Center of Central New Jersey is the lead sponsor of 17 studies on the registry; 7 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Male or female adults ≥ 18 years of age.
  2. Diagnosis of chronic plaque-type psoriasis.
  3. Able to give written informed consent prior to performance of any study related procedures.
  4. Treated with a biologic agent for a minimum of 24 weeks at baseline.
  5. Plaque-type psoriasis as defined at screening and baseline by BSA ≤ 5%.
  6. 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.
  7. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion criteria

Exclusion Criteria:

  1. >5% Body Surface Area
  2. Any condition, which would place the subject at unacceptable risk if he/she were to participate in the study.
  3. Pregnant or breast feeding, or considering becoming pregnant during the study.

  4. Malignancy or history of malignancy, except for:

    1. treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
    2. treated [ie, cured] malignancy with no evidence of recurrence within the previous 5 years.
  5. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
  6. 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).
  7. 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).
  8. Patient received UVB phototherapy within 2 weeks of Baseline.
  9. Patient received PUVA phototherapy within 4 weeks of Baseline.
  10. Patient has a known hypersensitivity to the excipients of Topicort Spray® as stated in the label.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    open label

    Topicort topical spray

    Drug: Topicort Topical Spray

Interventions

  • DrugTopicort Topical Spray

    open label Topicort spray

06

What researchers measure

Primary outcomes

  1. Psoriasis Severity

    Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.

    Time frame: 16 weeks

Secondary outcomes

  1. Psoriasis Severity

    Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis

    Time frame: 16 weeks

  2. Psoriasis Severity

    Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.

    Time frame: 16 weeks

  3. Dermatology Life Quality Index

    calculated by summing 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.

    Time frame: 16 weeks

07

Results

Posted May 7, 2018

Participant flow

Participant flow — Overall Study
MilestoneTopicort Topical Spray
Started20
Completed20
Not completed0

Outcome measures

PrimaryPsoriasis Severity

Physician's Global Assessment x Percentage of Body Surface Area (scale scores 0-400 where 0 is best psoriasis 400 is worst possible psoriasis) Body surface area calculated as 1 of patient's palm is 1%.

Time frame:
16 weeks
Reported as:
Mean · units on a scale
Psoriasis Severity
units on a scaleOpen Label
Psoriasis Severity4.25 ± 5.71
SecondaryPsoriasis Severity

Physician's Global Assessment Scores Scales 0-4 with 0 as no psoriasis and 4 is severe psoriasis

Time frame:
16 weeks
Reported as:
Mean · units on a scale
Psoriasis Severity
units on a scaleOpen Label
Psoriasis Severity1.65 ± .89
SecondaryPsoriasis Severity

Psoriasis severity measured as Body Surface area measured as 1 of patient's palm is equal to 1% body surface area.

Time frame:
16 weeks
Reported as:
Mean · percentage of BSA
Psoriasis Severity
percentage of BSAOpen Label
Psoriasis Severity2.05 ± 2.28
SecondaryDermatology Life Quality Index

calculated by summing 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.

Time frame:
16 weeks
Reported as:
Mean · units on a scale
Dermatology Life Quality Index
units on a scaleOpen Label
Dermatology Life Quality Index3.65 ± 4.08

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Open Label0/20 (0%)0/20 (0%)7/20 (35%)
Most frequent other events
Most frequent other events
EventOpen Label
worsening of psoriasisSkin and subcutaneous tissue disorders2/20
erythema multiformeSkin and subcutaneous tissue disorders1/20
hypertensionCardiac disorders1/20
sciatic neuralgiaNervous system disorders1/20
cough/congestionInfections and infestations1/20
hyperglycemiaMetabolism and nutrition disorders1/20

Baseline characteristics

Age, Continuous
Age, Continuous(years)Open Label
Mean53.33 ± 7.92
Sex: Female, Male
Sex: Female, Male(Participants)Open Label
Female5
Male15
Region of Enrollment
Region of Enrollment(participants)Open Label
United States20
08

Study locations

No study locations are listed for this record.

09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 11, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02983981
Lead sponsor
Psoriasis Treatment Center of Central New Jersey
Collaborators
Taro Pharmaceuticals USA
Responsible party
Sponsor
First posted
Dec 6, 2016
Start date
Mar 2016
Primary completion
Sep 2016
Completion
Oct 2016
Results posted
May 7, 2018
Last update
Mar 20, 2024

Study contacts

Jerry Bagel, MD
principal investigator · Director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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