Effect of LEO 80185 Gel on the HPA Axis and Calcium Metabolism in Subjects With Extensive Psoriasis Vulgaris

NCT01229098 | Completed Phase 2

• 1 other identifier: LEO 80185-G24
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this study is to evaluate the effect of once daily use of LEO 80185 gel on the hypothalamic-pituitary-adrenal (HPA) axis and calcium metabolism in subjects with extensive psoriasis vulgaris.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Safety

  * Subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge \[ Time Frame: Week 4 and week 8 \] \[ Designated as safety issue: Yes \] * Change in albumin-corrected serum calcium from baseline \[ Time Frame: Week 4 and week 8 \] \[ Designated as safety issue: Yes \] * Change in 24-hour urinary calcium excretion from baseline \[ Time Frame: Week 4 and week 8 \] \[ Designated as safety issue: Yes \] * Change in urinary calcium:creatinine ratio from baseline \[ Time Frame: Week 4 and week 8 \] \[ Designated as safety issue: Yes \]

  Up to 8 weeks

Secondary Outcomes (1)

• Efficacy

  Up to 8 weeks

Study Arms (1)

LEO 80185

EXPERIMENTAL

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

Interventions

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

LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel) Topical suspension applied once daily for up to 8 weeks

LEO 80185

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent obtained following receipt of verbal and written information about the study prior to any trial related activities (including any wash-out period).
• Age 18 years or above.
• Either sex.
• Any race or ethnicity.
• Attending a hospital out-subject clinic or the private practice of a dermatologist for treatment of psoriasis vulgaris.
• Clinical diagnosis of psoriasis vulgaris involving non scalp regions of the body (trunk and/or limbs) with or without involvement of the scalp.
• At SV2 and Day 0 (Visit 1) a clinical diagnosis of psoriasis vulgaris which is:
• amenable to topical treatment with a maximum of 100 g of study medication per week, and
• of an extent of between 15 and 30% of the body surface area (BSA) excluding psoriasis on the face, genitals or skin folds.
• a disease severity on the trunk and/or limbs graded as at least moderate according to the investigator's global assessment (IGA)
• Subjects with normal HPA axis function at SV2 including a serum cortisol concentration above 5 mcg/dL before ACTH challenge test and above 18 mcg/dL 30 minutes after ACTH challenge test.
• Albumin-corrected serum calcium, below the upper reference limit at SV2.
• Females of child-bearing potential must have a negative urine pregnancy test result at baseline Visit SV2 and must agree to use a highly effective method of contraception during the study. Highly effective methods are defined as ones which results in a low failure rate (less than 1% per year) such as progestin-only formulations (implants, injectables), some intra-uterine devices, or vasectomised partner. Subjects must have used the contraceptive method continuously for at least 1 month prior to the pregnancy test and must continue using the contraceptive method for at least 1 week after the last application of study medication (or until study visit FU2 if applicable). A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).
• Able to communicate with the investigator and understand and comply with the requirements of the study.

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 gel or CORTROSYN.
• Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 and during the study.
• Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on psoriasis vulgaris within the following time period prior to Day 0 (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, briakinumab - 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 psoriasis vulgaris (e.g., retinoids, methotrexate, immunosuppressants) within 4 weeks prior to Visit 1 (Day 0) or during the study.
• PUVA or Grenz ray therapy within 4 weeks prior to Visit 1 (Day 0) or during the study
• UVB therapy within 2 weeks prior to Visit 1 (Day 0) or during the study.
• Topical treatment with corticosteroids or vitamin D analogues (calcipotriol, calcitriol or tacalcitol) on any body location within 2 weeks prior to SV2 or during the study.
• Any topical treatment of psoriasis vulgaris on the scalp or trunk and/or limbs (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 (Day 0) or during the study.
• Oral calcium supplements, vitamin D supplements, antacids, thiazide and/or loop diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 and during the study. Note: Stable doses of oral vitamin D supplementation ≤400 IU/day is permitted provided there are no dose adjustments during the study period.
• Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g., betablockers, antimalarials, lithium, ACE inhibitors) during the study.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (10)

Winnipeg Clinic

Winnipeg, Manitoba, R3C 0N2, Canada

Location

Dermadvances Research

Winnipeg, Manitoba, R3C 1R4, Canada

Location

Alpha Clinical Research Centre

St. John's, Newfoundland and Labrador, A1B 4S8, Canada

Location

Newlab Clinical Research

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

Eastern Canada Cutaneous Research Associates Ltd.

Halifax, Nova Scotia, B3H 1Z4, Canada

Location

Dermsearch

London, Ontario, N5X 2P1, Canada

Location

Lynderm Research Inc.

Markham, Ontario, L3P 1A8, Canada

Location

Institute of Cosmetic and Laser Surgery

Oakville, Ontario, L6J 7W5, Canada

Location

Co-Medica Research Network Inc.

Oshawa, Ontario, L1E 3C3, Canada

Location

Oshawa Clinic

Oshawa, Ontario, L1H 1B9, Canada

Location

Related Publications (1)

• Silver S, Tuppal R, Gupta AK, Clonier F, Olesen M, Leeder R, Taraska V. Effect of calcipotriene plus betamethasone dipropionate topical suspension on the hypothalamic-pituitary-adrenal axis and calcium homeostasis in subjects with extensive psoriasis vulgaris: an open, non-controlled, 8-week trial. J Drugs Dermatol. 2013 Aug;12(8):882-7.

  PMID: 23986161 DERIVED

Related Links

• Clinical Trials at LEO Pharma

Study Officials

• Shane Silver, MB

  Dermadvances Research, 203 Edmonton Street, Winnipeg, Manitoba R3C 1R4 Canada

  PRINCIPAL INVESTIGATOR

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: October 26, 2010
• First Posted: October 27, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (10)