Effect of Calcipotriol Plus Hydrocortisone Ointment on the Adrenal Hormone Balance and Calcium Metabolism in Patients With Psoriasis Vulgaris on the Face and Skin Folds

NCT00704262 | Completed Phase 2 Results

• 1 other identifier: LEO 80190-O23
• Study Type: interventional
• Target: 33
• Locations: 4 countries
• Sites: 11

Brief Summary

There are few therapies suitable for the treatment of psoriasis on the face and skin folds. As these areas are sensitive, irritation and other adverse reactions are more common than elsewhere on the body. The purpose of the study is to monitor the effect of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g on the hypothalamic-pituitary-adrenal axis and on the calcium metabolism in patients with psoriasis vulgaris on the face and on the intertriginous areas

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (2)

• The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 and 60 Minutes

  The adrenal function was assessed by a rapid standard dose ACTH (tetracosactid/cosyntropin) challenge test. The ACTH challenge test consisted of a baseline blood (Day -7 to Day -3) sample taken at 8 a.m. (± 30 minutes). Following the baseline blood sample, an intravenous bolus injection of 250 mcg Synacthen®/Cortrosyn® was given at Time 0 (T = 0). Serum cortisol concentrations at 30 and 60 minutes after administration were taken and reflected the stimulation induced by tetracosactid/cosyntropin. ≤18 mcg/dL was considered low.

  At Week 4 (Day 28) and Week 8 (Day 56)

• Change in Albumin Corrected Serum Calcium

  Baseline was defined as the last assessment performed before study medication application. The end of treatment data was defined as the last value recorded during the treatment phase (i.e. Week 4, 6, or 8).

  From baseline to Week 4, Week 8, and end of treatment (last value recorded i.e. Week 4, 6, or 8)

Secondary Outcomes (11)

• The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 30 Minutes

  At Week 4 and Week 8

• The Adrenal Response to the ACTH Challenge Test Defined as the Serum Cortisol Concentration Obtained After 60 Minutes

  At Week 4 and Week 8

• Serum Cortisol Concentration After 30 Minutes

  At Week 4 and Week 8

• Serum Cortisol Concentration After 60 Minutes

  At Week 4 and Week 8

• Change in Albumin Corrected Serum Calcium

  From baseline to Week 2 and Week 6

Study Arms (1)

Calcipotriol plus hydrocortisone (LEO 80190)

EXPERIMENTAL

Drug: Calcipotriol plus hydrocortisone (LEO 80190)

Interventions

Calcipotriol plus hydrocortisone (LEO 80190) DRUG

Once daily application

Calcipotriol plus hydrocortisone (LEO 80190)

Eligibility Criteria

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

You may qualify if:

• Clinical diagnosis of psoriasis vulgaris involving the face and the intertriginous areas
• Clinical diagnosis of psoriasis vulgaris on the trunk and/or limbs or earlier diagnosed with psoriasis vulgaris on the trunk and/or limbs
• An extent of psoriatic involvement on the face of at least 5 cm2 and the sum of all facial and intertriginous lesions at least 30 cm2
• Treatment areas (face and intertriginous) amenable to topical treatment with a maximum of 100g ointment per week
• Disease severity of the face and intertriginous areas graded as moderate, severe or very severe according to the investigator´s global assessment of disease severity
• Patients with a normal HPA axis function: serum cortisol concentration above 5 mcg/dl before adrenocorticotropic hormone (ACTH: tetracosactid/cosyntropin) injection and serum cortisol concentration above 18 mcg/dl 30 min after ACTH (tetracosactid/cosyntropin) injection
• Albumin corrected serum calcium within reference range
• Females of childbearing potential have to use a highly effective method of contraception during the study (hormonal contraceptives on oestrogen basis are not allowed)

You may not qualify if:

• A history of active allergy, asthma, allergic skin rash, or sensitivity to any medication (including ACTH/tetracosactid/cosyntropin) or to any component of the formulations being tested
• Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (eg vitamin D analogues, retinoids)within 2 weeks prior to Visit 1. Stable treatment with methotrexate or fumaric acid is allowed
• Systemic treatment with corticosteroids within 12 weeks prior to Visit 1
• Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (eg. alefacept, efalizumab, etanercept, infliximab, adalimumab) within 12 weeks prior to Visit 1
• Psoralen plus ultraviolet light A (PUVA) therapy or Grenz ray therapy within 4 weeks prior to Visit 1
• Ultraviolet B (UVB) therapy within 2 weeks prior to Visit 1
• Topical treatment with World Health Organization (WHO) group 2, 3 or 4 corticosteroids within 4 weeks prior to Visit 1
• Topical treatment with WHO group 1 corticosteroids within 2 weeks prior to Visit 1
• Any topical treatment of the face and intertriginous areas (except for emollients) within 2 weeks prior to Visit 1
• Oestrogen therapy or any other medication known to affect cortisol levels or HPA-axis integrity within 4 weeks prior to Visit 1
• Enzymatic inductors, systemic or topical cytochrome P450 inhibitors, hypoglycaemic sulfonamides or antidepressive medication within 4 weeks prior to Visit 1
• Current diagnosis of erythrodermic, exfoliative, guttate or pustular psoriasis
• Patients with any of the following conditions present on the treatment 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, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers and wounds
• Other inflammatory skin diseases (e.g., seborrhoeic dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psoriasis vulgaris on the face or on the intertriginous areas
• Planned exposure to sun, Ultraviolet A (UVA) or UVB during the study that may affect the psoriasis vulgaris

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (11)

Burke Pharmaceuticals

Hot Springs, Arkansas, 71913, United States

Location

Dermatology Research of Arkansas

Little Rock, Arkansas, 72205, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Somerset Skin Center

Troy, Michigan, 48084, United States

Location

Psoriasis Treatment Center of Central NJ

East Windsor, New Jersey, 08520, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

The Guenther Dermatology Research Centre

London, Ontario, N6A3H7, Canada

Location

Institute of Clinical Pharmacology Parexel International Gmbh

Berlin, 12351, Germany

Location

LCG Bioscience

Bourn, Cambridge, CB3 7TR, United Kingdom

Location

ICON Development Solutions

Manchester, M15 6SH, United Kingdom

Location

The Dermatology Centre, Hope Hospital

Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Interventions

calcipotriene; Hydrocortisone

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids

Results Point of Contact

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

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Rainard Fuhr, MD, PhD

  Institute of Pharmacology Parexel International GmbH, Spandauer Damm 130, Haus 31, 14050 Berlin, Germany

  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: June 23, 2008
• First Posted: June 24, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 7, 2025
• Results First Posted: October 20, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3); CA (1); DE (1); US (6)