Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds

NCT00691002 | Completed Phase 3 Results

• 1 other identifier: LEO 80190-O21
• Study Type: interventional
• Target: 1,245
• 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 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 calcipotriol 25 mcg/g in the ointment vehicle, hydrocortisone 10 mg/g in the ointment vehicle and the ointment vehicle alone in patients with psoriasis vulgaris on the face and on the intertriginous areas (= double-blind phase). Furthermore, the safety and efficacy will be evaluated for up to 60 weeks treatment as required of calcipotriol 25 mcg/g plus hydrocortisone 10 mg/g ointment in psoriasis vulgaris on the face and intertriginous areas (= open-label phase).

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Participants With "Controlled Disease" According to the Investigator's Global Assessment(IGA) of Disease Severity of the Face at Week 8 (Visit 6) in the Double-blind Phase

  The (sub) investigator made an assessment of the disease severity of the face using the 6-category scale below. Clear, Almost clear, Mild, Moderate, Severe, Very severe The assessment was made considering the condition of psoriasis vulgaris of the face at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline (Visit 1) severity of moderate or worse - "controlled disease" of the face was defined as clear or almost clear according to the IGA of disease severity of the face. For subjects with a baseline (Visit 1) severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.

  At Week 8 (end of treatment for double-blind phase)

Secondary Outcomes (4)

• Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase

  At Week 4

• Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase

  At Week 8 (end of treatment for double-blind phase)

• Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase

  At Week 8 (end of treatment for double-blind phase)

• Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase

  At Week 8 (end of treatment for double-blind phase)

Study Arms (4)

LEO 80190

EXPERIMENTAL

Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190)

Drug: Calcipotriol plus hydrocortisone (LEO 80190)

LEO 80190 vehicle

PLACEBO COMPARATOR

Ointment Vehicle

Drug: LEO 80190 Vehicle

Calcipotriol

ACTIVE COMPARATOR

Calcipotriol 25 mcg/g in the ointment vehicle

Drug: Calcipotriol

Hydrocortisone

ACTIVE COMPARATOR

Hydrocortisone 10 mg/g in the ointment vehicle

Drug: Hydrocortisone

Interventions

Calcipotriol plus hydrocortisone (LEO 80190) DRUG

Once daily application

LEO 80190

LEO 80190 Vehicle DRUG

LEO 80190 vehicle

Hydrocortisone DRUG

Hydrocortisone

Calcipotriol DRUG

Calcipotriol

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 100 g of ointment per week
• 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 double-blind phase of 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
• 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., seborrhoiec dermatitis, contact dermatitis and cutaneous mycosis) that may confound the evaluation of psorisis 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 hypercalcaemia

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (11)

Croatia - managed by CRO

Zagreb, 10000, Croatia

Location

Macedonia - managed by CRO

Zagreb, 10000, Croatia

Location

Slovenia - managed by CRO

Zagreb, 10000, Croatia

Location

Department of Dermatology and Allergy, University of Bonn

Bonn, 53105, Germany

Location

Czech Republic - managed by CRO

Warsaw, 02-019, Poland

Location

Hungary - managed by CRO

Warsaw, 02-019, Poland

Location

Latvia - managed by CRO

Warsaw, 02-019, Poland

Location

Poland - managed by CRO

Warsaw, 02-019, Poland

Location

Belgium - managed by CRO

Warsaw, Poland

Location

The Netherlands - managed by CRO

Warsaw, Poland

Location

Serbia - managed by CRO

New Belgrade, 11070, Serbia

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

• Thomas Bieber, MD

  Department of Dermatology and Allergy, University of Bonn

  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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: May 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 10, 2025
• Results First Posted: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (6); SE (1); DE (1); CR (3)