Safety and Efficacy of LEO 80185 Topical Suspension in Adolescent Subjects (Aged 12 to 17) With Scalp Psoriasis

NCT01083758 | Completed Phase 2 Results

• 2 other identifiers: MBL 08012008-007606-11
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 6

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.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (14)

• Percentage of Subjects With Adverse Drug Reactions (ADRs)

  Adverse events for which the investigator did not describe the causal relationship to IP as not related

  Throughout trial, up to 8 weeks

• Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4

  Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.

  Week 4

• Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8

  Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 minutes after the injection.

  week 8

• Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTHchallenge at Week 4.

  Adrenal function can be measured by injecting a synthetic subunit of ACTH Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.

  week 4

• Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 and 60 Minutes After ACTH-challenge at Week 8.

  Adrenal function can be measured by injecting a synthetic subunit of ACTH (Adrenocorticotropic hormone), and then measure the production of cortisol by the adrenal glands in response to this at 30 and 60 minutes after the injection.

  week 8

• Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.

  Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

  Baseline and week 4

• Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.

  Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

  Baseline and week 8

• Change in Albumincorrected Serum Calcium From Baseline (SV2) to Week 4, Week 8, and End of Treatment.

  Change in albumincorrected serum calcium from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

  Baseline and end of treatment (up to 8 weeks)

• Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.

  Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

  Baseline and week 4

• Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.

  Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

  Baseline and week 8

• Change in 24-hour Urinary Calcium Excretion From Baseline (SV2) to Week 4, Week 8, and End of Treatment.

  Change in 24-hour urinary calcium excretion from Baseline (SV2 = screening visit 2) to Week 4, Week 8, and end of treatment.

  Baseline and end of treatment (up to 8 weeks)

• Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.

  Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.

  Baseline and week 4

• Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.

  Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.

  Baseline and week 8

• Change in Urinary Calcium:Creatinine Ratio From Baseline (SV2) to Week 4, Week 8 and, End of Treatment.

  Change in urinary calcium:creatinine ratio from Baseline (SV2 = screening visit 2) to Week 4, Week 8 and, end of treatment.

  Baseline and end of treatment (up to 8 weeks)

Secondary Outcomes (14)

• Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8

  Baseline and week 4

• Change in Plasma PTH From Baseline (SV2) to Week 4 and Week 8

  Baseline and week 8

• 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.

  week 2

• 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.

  week 4

• 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.

  week 8

Study Arms (1)

LEO 80185 (Taclonex® Scalp topical suspension/ Xamiol® gel)

OTHER

Drug: LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)

Interventions

LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel) DRUG

Topical suspension applied once daily for up to 8 weeks

Also known as: LEO 80185 topical suspension

LEO 80185 (Taclonex® Scalp topical suspension/ Xamiol® gel)

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (6)

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Leavitt Medical Associates of Florida, Inc.

Jacksonville, Florida, 32216, United States

Location

Leavitt Medical Associates of Florida, Inc.

Ormond Beach, Florida, 32174, United States

Location

Peachtree Dermatology Associates, PC

Atlanta, Georgia, 30327, United States

Location

Deaconess Clinic

Evansville, Indiana, 47714, United States

Location

Skin Specialists, PC

Omaha, Nebraska, 68144, United States

Location

Related Links

• Clinical Trials at LEO Pharma

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

ctr.disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Lawrence F Eichenfield, MD

  Rady Children's Hospital, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2010
• First Posted: March 10, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 11, 2025
• Results First Posted: October 12, 2015

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)