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The purpose of this study is to evaluate the safety and efficacy of 4 weeks of TACLONEX ointment in adolescent patients with psoriasis vulgaris.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TACLONEX ointment | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Calcipotriene plus betamethasone dipropionate ointment | Drug | Once daily application for 4 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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". | 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. | 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. | Week 4 |
| Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment | Baseline and 4 weeks | |
| Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. | Baseline and 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| "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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amy S Paller, MD | Northwestern University's Feinberg School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology Clinical Research | Fremont | California | 94538 | United States | ||
| University of California at San Diego/Rady Children's Hospital |
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| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | View source |
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Before starting treatment there was a washout/screening phase lasting for 3 days to 6 weeks, depending on the prior use of excluded treatments.
The study period was 15 July 2009 (date of first subject's first screening visit) to 05 December 2011 (date of the last subject's last on-treatment visit)
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| ID | Title | Description |
|---|---|---|
| FG000 | TACLONEX Ointment | TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 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). | 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. | 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. | 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. | Week 4 |
| San Diego |
| California |
| 92123 |
| United States |
| Ameriderm Research | Maitland | Florida | 32751 | United States |
| Northwestern University's Feinberg School of Medicine | Chicago | Illinois | 60611-2997 | United States |
| Arlington Research Center | Arlington | Texas | 76011 | United States |
| University of Texas-Dermatology | Houston | Texas | 77030 | United States |
| Virginia Clinical Research, Inc. | Norfolk | Virginia | 23507 | United States |
| DBA Dermatology Associates | Seattle | Washington | 98101 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TACLONEX Ointment | TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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". | Posted | Number | participants | Week 4 |
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| Primary | 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. | One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis | Posted | Number | participants | Week 4 |
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| Primary | 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. | One participant did not provide data for the ACTH-challenge test following the start of treatment, thus only 32 participants were included in this analysis | Posted | Number | participants | Week 4 |
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| Primary | Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment | Posted | Mean | Standard Deviation | mmol/L | Baseline and 4 weeks |
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| Primary | Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. | Posted | Mean | Standard Deviation | mmol/g | Baseline and 4 Weeks |
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| Secondary | "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. | Posted | Number | participants | Week 4 |
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| Secondary | "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). | Posted | Number | participants | Week 4 |
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| Secondary | 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. | Posted | Mean | 95% Confidence Interval | percentage | Baseline and 4 weeks |
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| Secondary | 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. | Posted | Number | participants | 4 weeks |
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| Secondary | 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. | Posted | Number | participants | Week 4 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TACLONEX Ointment | TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks | 0 | 33 | 10 | 33 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract | Infections and infestations | MedDRA 6.1 |
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| Headache | Nervous system disorders | MedDRA 6.1 |
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| Tension headache | Nervous system disorders | MedDRA (6.1) |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) |
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| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (6.1) |
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LEO acknowledges the investigators right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Malin Järnkrants | LEO Pharma A/S | +45 7226 2990 | malin.jaernkrants@leo-pharma.com |
| ID | Term |
|---|---|
| C055085 | calcipotriene |
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