Psoriasis VulgarisPhase 2NCT00817219
Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
A Phase 2 study testing Calcipotriene plus betamethasone dipropionate ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Calcipotriene plus betamethasone dipropionate ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 8 sitesUnited States
- Study dates
- Jul 2009to Dec 2011
- Phase
- Phase 2
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 12 to 17 years, inclusive.
- Psoriasis vulgaris on the trunk and/or limbs which is:
- amenable to topical treatment
- of an extent of 5-30% of BSA
- of at least a moderate severity
- A serum cortisol concentration above 5 mcg/dL before ACTH-challenge and above 18 mcg/dL at 30 minutes after ACTH-challenge.
- Albumin-corrected serum calcium and urinary calcium:creatinine ratio within the reference range.
Who cannot join
- Serious allergy, serious asthma, or serious allergic skin rash.
- A history of sensitivity to any medication.
- PUVA or Grenz ray therapy, UVB therapy, systemic treatment with biological therapies, corticosteroids, or other therapies with an effect on psoriasis, topical treatment with corticosteroids or vitamin D analogues, treatment with enzymatic inductors, cytochrome P450 inhibitors, hypoglycemic sulfonamides, antidepressive medications, estrogen therapy, calcium supplements or vitamin D supplements.
- Guttate, erythrodermic, exfoliative or pustular psoriasis.
- Viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds.
- Severe renal insufficiency, severe hepatic disorders, disorders of calcium metabolism associated with hypercalcemia, any cardiac condition or endocrine disorder.
- Diabetes mellitus
- Cushing's disease or Addison's disease.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Arlington Research Center
Arlington, Texas, 76011
Northwestern University's Feinberg School of Medicine
Chicago, Illinois, 60611-2997
Center for Dermatology Clinical Research
Fremont, California, 94538
University of Texas-Dermatology
Houston, Texas, 77030
Ameriderm Research
Maitland, Florida, 32751
Virginia Clinical Research, Inc.
Norfolk, Virginia, 23507
University of California at San Diego/Rady Children's Hospital
San Diego, California, 92123
DBA Dermatology Associates
Seattle, Washington, 98101
About this study
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
Read the detailed description
TACLONEX ointment has marketing approval in many countries for the treatment of psoriasis vulgaris in adults. No studies have been conducted in patients less than 18 years of age. However, about 25% of affected individuals are diagnosed between 10 and 19 years of age, hence psoriasis is also prevalent in the adolescent age group (12-17 years).
All patients will receive TACLONEX. To evaluate the safety of TACLONEX ointment, all adverse events will be recorded. In addition, any systemic absorption of the active components, betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal function (using CORTROSYN™ test) and calcium metabolism (by measuring serum calcium and the urinary calcium:creatinine ratio), respectively.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Calcipotriene plus betamethasone dipropionate ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriene plus betamethasone dipropionate ointmentDrug
Once daily application for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| TACLONEX ointment | Experimental | Not described Receives: Drug: Calcipotriene plus betamethasone dipropionate ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Reactions
The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as "not related".
Measured: Week 4
Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Measured: Week 4
Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Measured: Week 4
Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
Measured: Baseline and 4 weeks
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
Measured: Baseline and 4 Weeks
Secondary outcomes (5)
"Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4.
The investigator made an assessment of the disease severity (Plaque thickening, Scaling and Erythema) using a 6-point scale (Clear, Almost clear, Mild, Moderate, Severe, and Very severe). This assessment represented the average lesion severity on the trunk and limbs.
Measured: Week 4
"Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.
The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).
Measured: Week 4
Percentage Change in PASI From Baseline to Week 4.
PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
Measured: Baseline and 4 weeks
PASI 75 at Week 4.
PASI 75 is at least 75% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator's assessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
Measured: 4 weeks
PASI 50 at Week 4.
PASI 50 is at least 50% reduction in PASI from baseline. PASI is Psoriasis Area and Severity Index and is based on the investigator'sassessment of extent and severity of the disease. It can range from 0 (best) to 64.8(worst). The PASI used in this trial is modified to exclude assessment of the head, as trial treatment is not used here.
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2011
- Study completionDec 2011
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 Psoriasis VulgarisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amy S Paller, MD, Principal investigator, Northwestern University's Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00817219
- Sponsor's protocol ID
- MCB 0501 INT
- Status last verified
- Mar 2015
- First submitted
- 5 Jan 2009
- Last updated
- 12 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT00817219
- Acronym / sponsor ID
- MCB 0501 INT
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Jan 2009 (estimated)
- Results
- Posted 7 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
Detailed description
TACLONEX ointment has marketing approval in many countries for the treatment of psoriasis vulgaris in adults. No studies have been conducted in patients less than 18 years of age. However, about 25% of affected individuals are diagnosed between 10 and 19 years of age, hence psoriasis is also prevalent in the adolescent age group (12-17 years).
All patients will receive TACLONEX. To evaluate the safety of TACLONEX ointment, all adverse events will be recorded. In addition, any systemic absorption of the active components, betamethasone dipropionate and calcipotriene, will be evaluated by assessing adrenal function (using CORTROSYN™ test) and calcium metabolism (by measuring serum calcium and the urinary calcium:creatinine ratio), respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACLONEX ointment | Experimental | Drug: Calcipotriene plus betamethasone dipropionate ointment |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged 12 to 17 years, inclusive.
- Psoriasis vulgaris on the trunk and/or limbs which is:
- amenable to topical treatment
- of an extent of 5-30% of BSA
- of at least a moderate severity
Key exclusion criteria (8 listed)
- Serious allergy, serious asthma, or serious allergic skin rash.
- A history of sensitivity to any medication.
- PUVA or Grenz ray therapy, UVB therapy, systemic treatment with biological therapies, corticosteroids, or other therapies with an effect on psoriasis, topical treatment with corticosteroids or vitamin D analogues, treatment with enzymatic inductors, cytochrome P450 inhibitors, hypoglycemic sulfonamides, antidepressive medications, estrogen therapy, calcium supplements or vitamin D supplements.
- Guttate, erythrodermic, exfoliative or pustular psoriasis.
- Viral lesions of the skin, fungal or bacterial skin infections, ulcers or wounds.
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 |
|---|---|---|
| Calcipotriene plus betamethasone dipropionate ointmentOnce daily application for 4 weeks | Drug | TACLONEX ointment |
Primary outcome
Adverse Drug Reactions
Time frame: Week 4
The number of participants experiencing each type of adverse drug reaction. Adverse drug reactions were defined as adverse events for which the investigator had not described the causal relationship to trial medication as "not related".
Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment
Time frame: Week 4
The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment
Time frame: Week 4
The ACTH(Adrenocorticotropic hormone)-challenge test involves injecting a synthetic subunit of ACTH into the patient,and measuring the cortisol produced by the adrenal glands 30 and 60 minutes after the injection.
Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
Time frame: Baseline and 4 weeks
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
Time frame: Baseline and 4 Weeks
5 secondary outcomes
"Controlled Disease"(i.e., "Clear" or "Almost Clear") According to the Investigator's Global Assessment of Disease Severity at Week 4.
Time frame: Week 4
"Controlled Disease"(i.e., "Clear" or "Very Mild") According to the Patient's Global Assessment of Disease Severity at Week 4.
Time frame: Week 4
Percentage Change in PASI From Baseline to Week 4.
Time frame: Baseline and 4 weeks
PASI 75 at Week 4.
Time frame: 4 weeks
PASI 50 at Week 4.
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- 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.
Amy S Paller, MD principal investigator
Northwestern University's Feinberg School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Calcipotriene plus betamethasone dipropionate ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 8 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 7 inclusion and 8 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 7 Jan 2013). 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?
Adverse Drug Reactions (time frame: Week 4). The study lists 5 primary outcomes in all. 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 12 Mar 2025.