Psoriasis Vulgaris
Conditions
Brief 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.
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.
Interventions
DRUGCalcipotriene plus betamethasone dipropionate ointment
Once daily application for 4 weeks
Sponsors
LEO Pharma
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. | Baseline and 4 Weeks | — |
| Adverse Drug Reactions | 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 | 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 | 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 | Baseline and 4 weeks | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Controlled Disease(i.e., Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity at Week 4. | 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. |
| Controlled Disease(i.e., Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4. | Week 4 | The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe). |
| Percentage Change in PASI From Baseline to Week 4. | Baseline and 4 weeks | 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. |
| PASI 75 at Week 4. | 4 weeks | 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. |
| PASI 50 at Week 4. | 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. |
Countries
United States
Participant flow
Recruitment details
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)
Pre-assignment details
Before starting treatment there was a washout/screening phase lasting for 3 days to 6 weeks, depending on the prior use of excluded treatments.
Participants by arm
| Arm | Count |
|---|---|
| TACLONEX Ointment TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks | 33 |
| Total | 33 |
Baseline characteristics
| Characteristic | TACLONEX Ointment |
|---|---|
| Age, Continuous | 14.6 years STANDARD_DEVIATION 1.6 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 10 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
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.
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACLONEX Ointment | Adverse Drug Reactions | 2 participants |
Primary
Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TACLONEX Ointment | Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment | 0.005 mmol/L | Standard Deviation 0.094 |
Primary
Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.
Time frame: Baseline and 4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TACLONEX Ointment | Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. | 0.717 mmol/g | Standard Deviation 2.877 |
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.
Time frame: Week 4
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACLONEX Ointment | Serum Cortisol Concentration of ≤18 mcg/dL at 30 and 60 Minutes After ACTH-challenge at End of Treatment | 0 participants |
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.
Time frame: Week 4
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACLONEX Ointment | Serum Cortisol Concentration of ≤18 mcg/dL at 30 Minutes After ACTH-challenge at End of Treatment | 0 participants |
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.
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACLONEX Ointment | Controlled Disease(i.e., Clear or Almost Clear) According to the Investigator's Global Assessment of Disease Severity at Week 4. | 20 participants |
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).
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACLONEX Ointment | Controlled Disease(i.e., Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Week 4. | 23 participants |
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.
Time frame: Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACLONEX Ointment | PASI 50 at Week 4. | 28 participants |
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.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| TACLONEX Ointment | PASI 75 at Week 4. | 17 participants |
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.
Time frame: Baseline and 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TACLONEX Ointment | Percentage Change in PASI From Baseline to Week 4. | -72.5 percentage |