Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment Compared With Tacalcitol Ointment in Patients With Psoriasis on the Face and Skin Folds

NCT00640822 | Completed Phase 3 Results

• 1 other identifier: LEO 80190-O22
• Study Type: interventional
• Target: 782
• Locations: 3 countries
• Sites: 3

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 compare the efficacy and safety of once daily treatment for up to 8 weeks of an ointment containing calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g with tacalcitol 4 mcg/g ointment and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous ares

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Subjects With Controlled Disease According to the Investigator Assessment of the Face at Week 8

  Week 8

Secondary Outcomes (7)

• Overall Disease Severity of the Face According to the Investigator's Assessment

  Week 4

• Total Sign Score of the Face

  Week 8

• Severity Scores for Redness, Thickness and Scaliness of the Face

  Week 8

• Overall Disease Severity of the Intertriginous Areas According to the Investigator's Assessment

  Week 8

• Total Sign Score of the Intertriginous Areas

  Week 8

Study Arms (3)

Calcipotriol plus Hydrocortisone ointment

EXPERIMENTAL

Calcipotriol plus Hydrocortisone ointment once daily for up to 8 weeks

Drug: Calcipotriol plus hydrocortisone ointment

Tacalcitol

ACTIVE COMPARATOR

Tacalcitol once daily for up to 8 weeks

Drug: Tacalcitol Ointment

Calcipotriol plus Hydrocortisone ointment vehicle

PLACEBO COMPARATOR

Calcipotriol plus Hydrocortisone ointment vehicle once daily for up to 8 weeks

Drug: Calcipotriol plus hydrocortisone ointment vehicle

Interventions

Calcipotriol plus hydrocortisone ointment vehicle DRUG

Once daily application for up to 8 weeks

Calcipotriol plus Hydrocortisone ointment vehicle

Tacalcitol Ointment DRUG

Once daily application for up to 8 weeks

Tacalcitol

Calcipotriol plus hydrocortisone ointment DRUG

Once daily application for up to 8 weeks

Calcipotriol plus Hydrocortisone ointment

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
• Clinical signs of psoriasis vulgaris on the trunk and/or the limbs, or earlier diagnosed with psoriasis vulgaris on the trunk and/or the limbs
• An extent of psoriatic involvement of the face of at least 10 cm2 (the sum of all facial lesions)
• Treatment areas (the face and the intertriginous areas) amenable to topical treatment with a maximum of 10 g of ointment per day
• Disease severity graded as mild, moderate, severe or very severe according to the investigator's global assessment of disease severity of the face

You may not qualify if:

• Systemic treatments with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, vitamin D analogues, retinoids, immunosuppressants) within the 4-week period prior to randomisation
• Systemic use of biological treatments, whether marketed or not, directed against or with a potential effect on psoriasis vulgaris (e.g., alefacept, efalizumab, etanercept, infliximab, adalimumab) within 3 months prior to randomisation
• PUVA therapy or Grenz ray therapy within the 4-week period prior to randomisation
• UVB therapy within the 2-week period prior to randomisation
• Topical treatment of the face and the intertriginous areas within the 2-week period prior to randomisation (use of emollients is allowed on treatment areas during this 2-week period, but not during the study)
• Topical treatment with very potent WHO group IV corticosteroids within the 2-week period prior to randomisation
• Initiation of or expected changes in concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, anti-malaria drugs, lithium and ACE inhibitors) during the study
• Systemic treatment with vitamin D preparations above 500 IU per day
• 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, UVA or UVB that may affect the psoriasis vulgaris during the study
• Known or suspected severe renal insufficiency or severe hepatic disorders
• Known or suspected disorders of calcium metabolism associated with hypercalcemia

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (3)

Probity Medical Research

Waterloo, Ontario, N2J1C4, Canada

Location

Hôpital de l'Archet

Nice, 06202, France

Location

Ninewells Hospital & Medical School

Dundee, DD1 9SY, United Kingdom

Location

MeSH Terms

Interventions

calcipotriene

Results Point of Contact

• Title: Torsten Skov
• Organization: LeoPharma

torsten.skov@leo-pharma.com

+4520736294

Study Officials

• Colin Fleming, MD

  Ninewells Hospital & Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2008
• First Posted: March 21, 2008
• Study Start: February 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 7, 2025
• Results First Posted: December 21, 2010

Record last verified: 2015-04

Data Sharing

• IPD Sharing: Will not share

Locations

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