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

• ClinicalTrials.gov Identifier: NCT00817219
• Recruitment Status: Completed
• First Posted: January 6, 2009
• Results First Posted: January 7, 2013
• Last Update Posted: April 14, 2015
• Sponsor: LEO Pharma
• Information provided by (Responsible Party): LEO Pharma

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis Vulgaris	Drug: Calcipotriene plus betamethasone dipropionate ointment	Phase 2

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 33 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of TACLONEX Ointment in Adolescent Patients (Aged 12 to 17 Years) With Psoriasis Vulgaris
• Study Start Date: July 2009
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

Arm	Intervention/treatment
Experimental: TACLONEX ointment	Drug: Calcipotriene plus betamethasone dipropionate ointment; Once daily application for 4 weeks

Outcome Measures

Primary Outcome Measures :

1. 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".
2. 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.
3. 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.
4. Change in Albumin Corrected Serum Calcium From Baseline to End of Treatment [ Time Frame: Baseline and 4 weeks ]
5. Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment. [ Time Frame: Baseline and 4 Weeks ]

Secondary Outcome Measures :

1. "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 ]
   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.
2. "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 ]
   The patient made an assessment of the disease severity using a 5-point scale (Clear, Very Mild, Mild, Moderate, and Severe).
3. Percentage Change in PASI From Baseline to Week 4. [ Time Frame: 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.
4. PASI 75 at Week 4. [ Time Frame: 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.
5. PASI 50 at Week 4. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

Center for Dermatology Clinical Research

Fremont, California, United States, 94538

University of California at San Diego/Rady Children's Hospital

San Diego, California, United States, 92123

United States, Florida

Ameriderm Research

Maitland, Florida, United States, 32751

United States, Illinois

Northwestern University's Feinberg School of Medicine

Chicago, Illinois, United States, 60611-2997

United States, Texas

Arlington Research Center

Arlington, Texas, United States, 76011

University of Texas-Dermatology

Houston, Texas, United States, 77030

United States, Virginia

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States, 23507

United States, Washington

DBA Dermatology Associates

Seattle, Washington, United States, 98101

Sponsors and Collaborators

LEO Pharma

Investigators

• Principal Investigator: Amy S Paller, MD; Northwestern University's Feinberg School of Medicine

More Information

• Responsible Party: LEO Pharma
• ClinicalTrials.gov Identifier: NCT00817219
• Other Study ID Numbers: MCB 0501 INT
• First Posted: January 6, 2009
• Results First Posted: January 7, 2013
• Last Update Posted: April 14, 2015
• Last Verified: March 2015

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Anti-Asthmatic Agents; Respiratory System Agents; Dermatologic Agents