Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Official title:

Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00817219
• Other study ID #: MCB 0501 INT
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2009
• Last updated: March 25, 2015
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• Calcipotriene plus betamethasone dipropionate ointment
Once daily application for 4 weeks

Locations

Country	Name	City	State
United States	Arlington Research Center	Arlington	Texas
United States	Northwestern University's Feinberg School of Medicine	Chicago	Illinois
United States	Center for Dermatology Clinical Research	Fremont	California
United States	University of Texas-Dermatology	Houston	Texas
United States	Ameriderm Research	Maitland	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	University of California at San Diego/Rady Children's Hospital	San Diego	California
United States	DBA Dermatology Associates	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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".	Week 4	Yes
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.	Week 4	Yes
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.	Week 4	Yes
Primary	Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment		Baseline and 4 weeks	Yes
Primary	Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment.		Baseline and 4 Weeks	Yes
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.	Week 4	No
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).	Week 4	No
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.	Baseline and 4 weeks	No
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.	4 weeks	No
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.	Week 4	No

External Links

•   Clinical Trials at LEO Pharma