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PsoriasisPhase 1NCT01563068

Safety, Tolerability, PD & PK of Calcipotriene 0.005% Foam, Under Maximal Use in 12-16 Year Olds With Plaque Psoriasis

A Phase 1 study testing Calcipotriene 0.005% Foam in people with Psoriasis, run by Mayne Pharma International Pty Ltd at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. Read more about this study

Who is it for?
Ages 12 to 16 years
Conditions the study is for
Psoriasis
What is being tested?
Calcipotriene 0.005% Foam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
9 sitesUnited States
Study dates
Apr 2012to Aug 2015
Phase
Phase 1
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 12 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Male or female subjects, ages 12 to 16 years, inclusive, at the time of consent.
  • Plaque psoriasis involving 10% body surface area (excluding the scalp and face).
  • 20% scalp involvement (excluding the body and face).
  • Clinical diagnosis of mild to moderate plaque psoriasis, as defined by an ISGA score at Screening of 3 on a scale of 0 to 4.
  • The ability and willingness of the subject and the subject's primary caregiver to follow all study procedures, attend all scheduled visits, and successfully complete the study.
  • 5. The subject's parent(s) or legal guardian must have the ability to understand and sign a written informed consent form and a Health Insurance Portability and Accountability Act (HIPAA) authorization form, which must be obtained prior to participation in this study. The HIPAA authorization may be incorporated in the informed consent form. Also, the subject's assent must be obtained and documented.

Who cannot join

  • Any inflammatory skin disease in the treatment area that may confound the evaluation of the plaque psoriasis (eg, atopic dermatitis, contact dermatitis, tinea corporis).
  • Current diagnosis of unstable forms of psoriasis in the treatment area, including guttate, erythrodermic, exfoliative, or pustular psoriasis.
  • Use of any topical product (including sunscreen, creams, ointments, lotions, and powders) applied on or near the treatment area within 48 hours prior to enrollment.
  • Use of topical treatments that have a known beneficial effect on psoriasis, including but not limited to corticosteroids, retinoids, vitamin D derivatives, coal tar, tazarotene, or anthralin, medicated shampoos within 2 weeks prior to enrollment.
  • Use of nonbiologic systemic antipsoriatic therapy (eg, corticosteroids, retinoids, methotrexate, cyclosporine, other immunosuppressive agents), biologic therapy (eg, alefacept, etanercept, efalizumab), or phototherapy (eg, ultraviolet A, psoralen and ultraviolet A, ultraviolet B) within 4 weeks prior to enrollment.
  • Use or need for initiation of any nonpsoriatic therapy that might affect psoriasis (including antimalarials, adrenergic receptor blockers, interferon, or lithium) within 4 weeks prior to enrollment.
Show all 19Show fewer
  • Use of medications that affect or change calcium and parathyroid hormone (PTH) concentrations or interfere with the measurement of calcium or PTH concentrations within 4 weeks prior to enrollment.
  • Known difficult venous access beyond that expected for subject age.
  • Any serious skin disorder or any chronic medical condition that is not well controlled.
  • Positive urine drug screen result for alcohol, cotinine, or drugs of abuse at the time of Screening.
  • Average daily ingestion of more than 2000 mg of elemental calcium or more than 1000 IU of vitamin D within 2 weeks prior to enrollment.
  • Current drug or alcohol abuse.
  • History of hypersensitivity, known allergy, or other adverse reaction to calcipotriene or other vitamin D analogs or to any component of the study product.
  • Current or past history of hypercalcemia, vitamin D toxicity, severe renal insufficiency, or severe hepatic disorders.
  • Use of any investigational therapy within 4 weeks prior to enrollment.
  • Pregnant, breastfeeding, or sexually active female subjects of childbearing potential (after menarche) who are not practicing an acceptable method of contraception. Acceptable methods of contraception include one of the following highly effective methods of contraception (ie, Pearl Index <1.0%): complete abstinence from intercourse or 2 forms of barrier contraception (diaphragm plus spermicide for females, condom plus spermicide for males), or systemic contraceptives (combined or progesterone only) used in combination with a condom. The subject must agree to use an acceptable method of contraception from 2 weeks prior to administration of study product, throughout the study, and for 28 days after completion or premature discontinuation from the study.
  • Current immunosuppression.
  • Albumin-adjusted serum calcium at Screening that is outside the normal reference range.
  • Any other condition that, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Investigational Site

    Chicago, Illinois, 60611

  • Investigational Site

    Houston, Texas, 77030

  • Investigational Site

    Indianapolis, Indiana, 46256

  • Investigational Site

    Louisville, Kentucky, 40217

  • Investigational Site

    Marietta, Georgia, 30060

  • Investigational Site

    Ormond Beach, Florida, 32174

  • Investigational Site

    Philadelphia, Pennsylvania, 19103

  • Investigational Site

    San Diego, California, 92123

  • Investigational Site

    Tampa, Florida, 33609

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Calcipotriene Foam, 0.005%, Applied Under Maximal-Use Conditions in Adolescent Subjects (Ages 12 to 16 Years) With Plaque Psoriasis

Calcipotriene is a vitamin D3 analog that has been used as topical therapy in adult subjects with plaque-type psoriasis since 1993. Calcipotriene foam, 0.005%, was approved in 2010 for the treatment of plaque psoriasis in adults aged 18 years and older. The current study is a multicenter study in which adolescent subjects (ages 12 to 16 years, inclusive) or their primary caregivers will apply calcipotriene foam, 0.005%, as a thin layer to treatment areas of the body and scalp, excluding the face, under maximal use conditions, twice a day for 14 days and once on Day 15. The safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene will be evaluated

Read the detailed description

This Phase 1 multicenter, open-label, repeat-dose study is designed to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of calcipotriene foam, 0.005%, applied topically to adolescent subjects with moderate plaque psoriasis (defined as a score of 3 on the Investigator's Static Global Assessment [ISGA]) involving a minimum of 10% body surface area (BSA) excluding the face and scalp, and a minimum of 20% scalp involvement. Subjects will be enrolled no more than 2 weeks after Screening. Approximately 30 eligible subjects, ages 12 to 16 years, inclusive, will be enrolled to ensure 20 completing subjects. Calcipotriene foam will be applied as a thin layer twice a day for 14 days and once on Day 15 on all treatment areas. Blood samples for the evaluation of albumin adjusted calcium, intact parathyroid hormone (iPTH), alkaline phosphatase, magnesium, and phosphorus will be taken at Screening and on Day 1 (before the first dose), Day 15 (3 to 9 hours after dosing), and on Day 22 if the results from Day 15 show any abnormalities. Serum 25-OH vitamin D concentrations will be evaluated on Day 1 (before the first dose). Safety and tolerability will be evaluated throughout the treatment period and a 7 day follow-up period. Blood samples for pharmacokinetic (PK) evaluation will be collected on Days 1 and 15. Urine samples for evaluation of calcium/creatinine ratio will be collected before dosing on Days 1 and 15.

Conditions
Psoriasis
Being tested
Calcipotriene 0.005% Foam
Keywords
plaque psoriasis, pediatric, adolescent
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Calcipotriene 0.005% FoamDrug

    Also called Sorilux

    Topical application applied twice a day for 15 days

Study groups in NCT01563068
Study groupRoleWhat they receive
Calcipotriene FoamExperimentalCalcipotriene foam 0.005% administered under maximal-use conditions to adolescent patients with plaque psoriasis
Receives: Drug: Calcipotriene 0.005% Foam

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of calcium metabolism

    determine albumin-adjusted calcium, iPTH, alkaline phosphatase, and phosphorus

    Measured: Up to 3 Weeks

Secondary outcomes (1)

  1. Pharmacokinetics

    Area Under Curve (AUC)

    Measured: predose, 1,2,3,4,6 hours postdose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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 1
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01563068
Sponsor's protocol ID
STF115750
Status last verified
May 2018
First submitted
15 Mar 2012
Last updated
11 May 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Calcipotriene 0.005% Foam in people with Psoriasis, run by Mayne Pharma International Pty Ltd at 9 sites 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 6 inclusion and 19 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 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Effect of calcium metabolism (time frame: Up to 3 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01563068.

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 11 May 2018; AzTrials last refreshed its copy on 8 Nov 2026.

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