Clinical trial NCT01083758: Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis
Official title: Effect of Calcipotriol Plus Betamethasone Dipropionate Topical Suspension on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 17 Years) With Scalp Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scalp Psoriasis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-03-10
Enrollment: 31
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 topical suspension in adolescent subjects (aged 12 to 17 years) with scalp psoriasis. LEO 80185 topical suspension has marketing approval in many countries under the brand names Taclonex Scalp® Topical Suspension and Xamiol® gel for the treatment of scalp psoriasis in adults. No studies have been performed in subjects younger than 18 years.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent given by parent(s) or legal guardian following their receipt of verbal and written information about the study
* Subjects will receive verbal and written information and will provide written assent to the study
* Any race or ethnicity
* Clinical signs of psoriasis vulgaris on trunk and/or limbs, or earlier diagnosed with psoriasis vulgaris on trunk and/or limbs
* At Screening Visit 2 and Visit 1 a clinical diagnosis of scalp psoriasis which is:

  * amenable to topical treatment with a maximum of 60 g of study medication per week, and
  * of an extent of more than or equal to 20% of the scalp area
  * of at least moderate severity according to the investigator's global assessment
* Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge
* A serum albumin-corrected calcium below the upper reference limit at Screening Visit 2
* Females of child-bearing potential must have a negative urine pregnancy test result and must agree to use a highly effective method of contraception (abstinence is an acceptable method).

Exclusion Criteria (summary):

* A history of serious allergy, allergic asthma or serious allergic skin rash
* Known or suspected hypersensitivity to any medication (including ACTH/cosyntropin/tetracosactide) or to any component of the LEO 80185 topical suspension or CORTROSYN
* Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to Screening Visit 2 or during the study
* Topical treatment with corticosteroids within 2 weeks prior to Screening Visit 2 or during the study
* Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to Screening Visit 2 or during the study
* Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin)or cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to Screening Visit 2 or during the study. Topical ketoconazole 2 weeks prior to Screening Visit 2
* Hypoglycemic sulfonamides or Antidepressive medications within 4 weeks prior to Screening Visit 2 or during the study
* Known or suspected endocrine disorder that may affect the results of the ACTH challenge test
* Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
* Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study
* Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study
* Other inflammatory skin diseases that may confound the evaluation of scalp psoriasis
* Known or suspected disorders of calcium metabolism associated with hypercalcaemia

Primary outcomes:
measure: Percentage of Subjects With Adverse Drug Reactions (ADRs)
timeFrame: Throughout trial, up to 8 weeks
measure: Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
timeFrame: Week 4
measure: Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8
timeFrame: week 8
measure: Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.
timeFrame: week 4
measure: Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.
timeFrame: week 8
measure: Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
timeFrame: Baseline and week 4
measure: Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
timeFrame: Baseline and week 8
measure: Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
timeFrame: Baseline and end of treatment (up to 8 weeks)
measure: Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
timeFrame: Baseline and week 4
measure: Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
timeFrame: Baseline and week 8
measure: Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.
timeFrame: Baseline and end of treatment (up to 8 weeks)
measure: Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.
timeFrame: Baseline and week 4
measure: Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.
timeFrame: Baseline and week 8
measure: Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.
timeFrame: Baseline and end of treatment (up to 8 weeks)
Secondary outcomes:
measure: Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8
timeFrame: Baseline and week 4
measure: Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8
timeFrame: Baseline and week 8
measure: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: week 2
measure: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: week 4
measure: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: week 8
measure: Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: End of treatment
measure: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
timeFrame: week 2
measure: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
timeFrame: Baseline and week 4
measure: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign, Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
timeFrame: Baseline and week 8
measure: Percentage Change in Total Sign Score (TSS; Sum of Severity Scores for Each Individual Clinical Sign,Redness, Thickness, and Scaliness) From Baseline to Weeks 2, 4, 8, and End of Treatment.
timeFrame: Baseline and end of treatment (up to 8 weeks)
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: week 2
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: week 4
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: week 8
measure: Subjects With Controlled Disease (Defined as Clear or Very Mild) According to the Patient's Global Assessment of Disease Severity at Weeks 2, 4, 8, and End of Treatment.
timeFrame: End of treatment
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: Jacksonville
country: United States
facility: Leavitt Medical Associates of Florida, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Leavitt Medical Associates of Florida, Inc.
state: Florida
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates, PC
state: Georgia
city: Evansville
country: United States
facility: Deaconess Clinic
state: Indiana
city: Omaha
country: United States
facility: Skin Specialists, PC
state: Nebraska
Study officials:
affiliation: Rady Children's Hospital, San Diego
name: Lawrence F Eichenfield, MD
role: PRINCIPAL_INVESTIGATOR
References: