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

NCT01120223 | Completed Phase 2 Results

• 2 other identifiers: MBL 0412 INT2008-005456-24
• Study Type: interventional
• Target: 78
• Locations: 3 countries
• Sites: 17

Brief Summary

The purpose of the study is to evaluate the safety and efficacy of once daily use of LEO 80185 gel in adolescent subjects (aged 12 to 17) with scalp psoriasis. LEO 80185 gel has marketing approval in many countries under the brand names Xamiol® gel and Taclonex Scalp® Topical Suspension 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 (10)

• 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

• Change in Albumincorrected Serum Calcium From Baseline to Week 4

  Change in albumincorrected serum calcium from Baseline to week 4

  Baseline and week 4

• Change in Albumincorrected Serum Calcium From Baseline to Week 8

  Change in albumincorrected serum calcium from Baseline to week 8

  Baseline and week 8

• Change in Albumincorrected Serum Calcium From Baseline to End of Treatment

  Change in albumincorrected serum calcium from Baseline to end of treatment

  Baseline and End of treatment (up to 8 weeks)

• Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4

  Change in 24-hour urinary calcium excretion from Baseline to week 4

  Baseline and week 4

• Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8

  Change in 24-hour urinary calcium excretion from Baseline to week 8

  Baseline and week 8

• Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment

  Change in 24-hour urinary calcium excretion from Baseline to end of treatment

  Baseline and End of treatment (up to 8 weeks)

• Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4

  Change in urinary calcium:creatinine ratio from Baseline to week 4

  Baseline and week 4

• Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8

  Change in urinary calcium:creatinine ratio from Baseline to week 8

  Baseline and week 8

• Change in Urinary Calcium:Creatinine Ratio From Baseline to End of Treatment

  Change in urinary calcium:creatinine ratio from Baseline to end of treatment

  Baseline and End of treatment (up to 8 weeks)

Secondary Outcomes (15)

• Change in Plasma PTH From Baseline to Week 4

  Baseline and week 4

• Change in Plasma PTH From Baseline to 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 Week 2

  Week 2

• Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 4

  Week 4

• Subjects With Controlled Disease (i.e., Clear or Almost Clear) According to the Investigator's Global Assessment (IGA) of Disease Severity at Week 8

  Week 8

Study Arms (1)

LEO 80185 gel once daily application

EXPERIMENTAL

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

Interventions

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

Once daily application

LEO 80185 gel once daily application

Eligibility Criteria

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

You may qualify if:

• A clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area
• A clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment
• Serum albumin-corrected calcium below the upper reference limit at screening visit 2

You may not qualify if:

• A history of hypersensitivity to any component of the LEO 80185 gel
• Topical treatment on the trunk and/or limbs with very potent (WHO group IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
• Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
• 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:
• etanercept - within 4 weeks prior to Visit 1
• adalimumab, alefacept, infliximab - within 2 months prior to Visit 1
• ustekinumab - within 4 months prior to Visit 1
• experimental products - 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., corticosteroids, retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study
• UVB therapy within 2 weeks prior to Visit 1 or during the study
• Any topical treatment on the scalp (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the study
• Systemic calcium or vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to screening visit 2 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
• Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
• Subjects with any of the following conditions present on the scalp area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (17)

Kirk Barber Research

Calgary, Alberta, T2G 1B1, Canada

Location

Winnipeg Clinic Dermatology Research

Winnipeg, Manitoba, R3C 0N2, Canada

Location

UltraNova Skincare

Barrie, Ontario, L4M 6L2, Canada

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A 3H7, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

SKiN Centre for Dermatology

Peterborough, Ontario, K9J 1Z2, Canada

Location

The Centre for Dermatology and Cosmetic Surgery

Richmond Hill, Ontario, L4B 1A5, Canada

Location

Royal University Hospital, Division of Dermatology

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

CHU Saint-Etienne - Hôpital Nord, Service de Dermatologie

Saint-Etienne, 42055, France

Location

Monklands Hospital

Airdrie, Lanarkshire, ML6 0JS, United Kingdom

Location

Burbage Surgery

Burbage, Leicestershire, LE10 2SE, United Kingdom

Location

Whipps Cross University Hospital

Leytonstone, London, E11 1NR, United Kingdom

Location

Hope Hospital

Salford, Manchester, M6 8HD, United Kingdom

Location

Harrogate District Hospital

Harrogate, North Yorkshire, HG2 7SX, United Kingdom

Location

Leeds General Infirmary

Leeds, W. Yorkshire, LS1 3EX, United Kingdom

Location

City Hospital

Birmingham, B18 7QH, United Kingdom

Location

Royal Gwent Hospital

Newport, NP20 2UB, United Kingdom

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

• Alexander V Anstey, MD

  Royal Gwent Hospital

  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: April 9, 2010
• First Posted: May 10, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 11, 2025
• Results First Posted: December 1, 2014

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); GB (8); CA (8)