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CompletedNCT00691002Updated Mar 10, 2025Results posted

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

A Phase 3 interventional study of Calcipotriol plus hydrocortisone (LEO 80190) and LEO 80190 Vehicle in Psoriasis Vulgaris, sponsored by LEO Pharma. Completed at 11 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-10.

Sponsored by LEO Pharma · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,245
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Psoriasis Vulgaris

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03

In context

Psoriasis

1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.

This study's enrollment of 1,245 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,245 participants (actual)

Study arms

  • Experimental
    LEO 80190

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

    Drug: Calcipotriol plus hydrocortisone (LEO 80190)

  • Placebo comparator
    LEO 80190 vehicle

    Ointment Vehicle

    Drug: LEO 80190 Vehicle

  • Active comparator
    Calcipotriol

    Calcipotriol 25 mcg/g in the ointment vehicle

    Drug: Calcipotriol

  • Active comparator
    Hydrocortisone

    Hydrocortisone 10 mg/g in the ointment vehicle

    Drug: Hydrocortisone

Interventions

  • DrugCalcipotriol plus hydrocortisone (LEO 80190)

    Once daily application

  • DrugLEO 80190 Vehicle
  • DrugHydrocortisone
  • DrugCalcipotriol
06

What researchers measure

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.

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

Secondary outcomes

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

    The assessment of the disease severity of the face was made 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 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 severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.

    Time frame: At Week 4

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

    "Success" was defined as a TSS score of 0 or 1. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured) The sum of the three scores constituted a TSS ranging from 0 to 12

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

  3. 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

    The (sub)investigator made an assessment of the disease severity of the intertriginous areas 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 intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas. For subjects with a baseline severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas.

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

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

    The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe Thickness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe Scaliness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS. "Success" was defined as a TSS score of 0 or 1.

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

07

Results

Posted Aug 26, 2021

Participant flow

A total of 1245 subjects were enrolled (informed consent signed and CRF started). Five subjects left the study during washout (2 screening failures, 2 lost to follow-up and 1 unacceptable adverse event). One subject attended Visit 1 but was not randomized (voluntary withdrawal). Therefore, 1239 of the enrolled subjects were randomized in the study.

8-week, Double-blind, 4-arm
Participant flow — 8-week, Double-blind, 4-arm
MilestoneLEO 80190CalcipotriolHydrocortisoneLEO 80190 VehicleOpen-label Phase
Started3533423631810
Completed3253083401690
Not completed283423120
52-week, Open-label, Single Arm
Participant flow — 52-week, Open-label, Single Arm
MilestoneLEO 80190CalcipotriolHydrocortisoneLEO 80190 VehicleOpen-label Phase
Started4540000
Completed4030000
Not completed510000

Outcome measures

PrimaryParticipants 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.

Time frame:
At Week 8 (end of treatment for double-blind phase)
Reported as:
Count of participants · Participants
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
ParticipantsLEO 80190CalcipotriolHydrocortisoneLEO 80190 Vehicle
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 Phase15813511541
Statistical analysis
  • LEO 80190 vs Calcipotriol · Cochran-Mantel-Haenszel · p = 0.11 · Odds ratio (or): 1.28 · 95% CI 0.94 to 1.74
  • LEO 80190 vs Hydrocortisone · Cochran-Mantel-Haenszel · p = <0.001 · Odds ratio (or): 1.79 · 95% CI 1.31 to 2.45
  • LEO 80190 vs LEO 80190 Vehicle · Cochran-Mantel-Haenszel · p = <0.001 · Odds ratio (or): 2.70 · 95% CI 1.80 to 4.04
SecondaryParticipants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase

The assessment of the disease severity of the face was made 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 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 severity of mild - "controlled disease" of the face was defined as clear according to the IGA of disease severity of the face.

Time frame:
At Week 4
Reported as:
Count of participants · Participants
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase
ParticipantsLEO 80190CalcipotriolHydrocortisoneLEO 80190 Vehicle
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase101666114
SecondaryParticipants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase

"Success" was defined as a TSS score of 0 or 1. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none (no erythema) 1 = mild (faint erythema, pink to very light red) 2 = moderate (definite light red erythema) 3 = severe (dark red erythema) 4 = very severe (very dark red erythema) Thickness 0 = none (no plaque elevation) 1 = mild (slight, barely perceptible elevation) 2 = moderate (definite elevation but not thick) 3 = severe (definite elevation, thick plaque with sharp edge) 4 = very severe (very thick plaque with sharp edge) Scaliness 0 = none (no scaling) 1 = mild (sparse, fine-scale lesions, only partially covered) 2 = moderate (coarser scales, most of lesions covered) 3 = severe (entire lesion covered with coarse scales) 4 = very severe (very thick coarse scales, possibly fissured) The sum of the three scores constituted a TSS ranging from 0 to 12

Time frame:
At Week 8 (end of treatment for double-blind phase)
Reported as:
Count of participants · Participants
Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase
ParticipantsLEO 80190CalcipotriolHydrocortisoneLEO 80190 Vehicle
Participants With "Success" According to Total Sign Score (TSS) of the Face at Week 8 (Visit 6) in the Double-blind Phase17113613142
SecondaryParticipants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase

The (sub)investigator made an assessment of the disease severity of the intertriginous areas 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 intertrigi-nous areas at the time of the evaluation, not in relation to the condition at a previous visit. For subjects with a baseline severity of moderate or worse - "controlled disease" of the intertriginous areas was defined as clear or almost clear according to the IGA of disease severity of the intertriginous areas. For subjects with a baseline severity of mild - "controlled disease" of the intertriginous areas was defined as clear according to the IGA of disease severity of the intertriginous areas.

Time frame:
At Week 8 (end of treatment for double-blind phase)
Reported as:
Count of participants · Participants
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
ParticipantsLEO 80190CalcipotriolHydrocortisoneLEO 80190 Vehicle
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase80554814
SecondaryParticipants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase

The severity of the subject's psoriasis vulgaris on the intertriginous areas was evaluated in terms of the three clinical signs: redness, thickness and scaliness. All the defined intertriginous areas were rated separately using the same scale as for the investigator's assessment of clinical signs (redness, thickness and scaliness) of the face. For each clinical sign, a single score, reflecting the average severity of all psoriatic lesions on the face was determined according to the scale below: Redness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe Thickness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe Scaliness 0 = none 1. = mild 2. = moderate 3. = severe 4. = very severe A mean score was calculated for each sign (redness, thickness and scaliness) based on scores of all the defined intertriginous areas with psoriasis at baseline and the sum of these mean scores constituted the TSS. "Success" was defined as a TSS score of 0 or 1.

Time frame:
At Week 8 (end of treatment for double-blind phase)
Reported as:
Count of participants · Participants
Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase
ParticipantsLEO 80190CalcipotriolHydrocortisoneLEO 80190 Vehicle
Participants With "Success" According to Total Sign Score of the Intertriginous Areas at Week 8 (Visit 6) in the Double-blind Phase82815915

Adverse events

Collected over Double-blind Phase: From baseline (Day 0) to end of trial (Day 56±2) + Follow-up (Day 14±2) Open-label Phase: From Week 8 to Week 60 ±7 days + Follow-up (Day 14±2). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
LEO 801900/351 (0%)5/351 (1.4%)91/351 (25.9%)
Calcipotriol0/341 (0%)5/341 (1.5%)100/341 (29.3%)
Hydrocortisone0/362 (0%)4/362 (1.1%)70/362 (19.3%)
LEO 80190 Vehicle0/181 (0%)0/181 (0%)47/181 (26%)
Open-label Phase0/453 (0%)24/453 (5.3%)266/453 (58.7%)
Most frequent serious events
Showing 10 of 32
Most frequent serious events
EventLEO 80190CalcipotriolHydrocortisoneLEO 80190 VehicleOpen-label Phase
PsoriasisSkin and subcutaneous tissue disorders2/3510/3412/3620/1813/453
ErysipelasInfections and infestations0/3510/3410/3620/1812/453
Clavicle fractureInjury, poisoning and procedural complications0/3510/3410/3620/1812/453
ContusionInjury, poisoning and procedural complications0/3510/3410/3620/1812/453
PregnancyPregnancy, puerperium and perinatal conditions0/3510/3410/3620/1812/453
Atrial fibrillationCardiac disorders0/3511/3410/3620/1810/453
PneumoniaInfections and infestations0/3511/3410/3620/1811/453
ArthritisMusculoskeletal and connective tissue disorders0/3511/3410/3620/1810/453
Benign bone neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/3511/3410/3620/1811/453
Laryngeal neoplasmNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/3511/3410/3620/1810/453
Most frequent other events
Showing 10 of 24
Most frequent other events
EventLEO 80190CalcipotriolHydrocortisoneLEO 80190 VehicleOpen-label Phase
PsoriasisSkin and subcutaneous tissue disorders26/35123/34127/36212/181114/453
NasopharyngitisInfections and infestations8/3515/34112/36211/18155/453
ErythemaSkin and subcutaneous tissue disorders7/35124/3417/3627/18113/453
PruritusSkin and subcutaneous tissue disorders7/35114/3413/3625/1818/453
HeadacheNervous system disorders11/3516/3418/3622/18117/453
Burning sensationNervous system disorders5/35112/3411/3624/1810/453
RhinitisRespiratory, thoracic and mediastinal disorders4/3511/3414/3620/18113/453
ArthralgiaMusculoskeletal and connective tissue disorders0/3510/3410/3620/18112/453
InfluenzaInfections and infestations3/3512/3412/3622/18110/453
CoughRespiratory, thoracic and mediastinal disorders0/3510/3410/3620/18110/453

Baseline characteristics

Age, Continuous
Age, Continuous(years)LEO 80190CalcipotriolHydrocortisoneLEO 80190 VehicleTotal
Mean42.8 ± 15.344.8 ± 15.143.0 ± 14.144.6 ± 15.143.6 ± 14.9
Sex: Female, Male
Sex: Female, Male(Participants)LEO 80190CalcipotriolHydrocortisoneLEO 80190 VehicleTotal
Female15513914776517
Male198203216105722
Region of Enrollment
Region of Enrollment(participants)LEO 80190CalcipotriolHydrocortisoneLEO 80190 VehicleTotal
Belgium465217
Croatia151316751
Czechia2922241590
Germany99959655345
Hungary58596435216
Latvia2320241077
Macedonia788326
Netherlands465116
Poland79768037272
Serbia34364016126
Slovenia11103
08

Study locations

11 sites
  • Croatia - managed by CRO
    Zagreb, 10000, Croatia
  • Macedonia - managed by CRO
    Zagreb, 10000, Croatia
  • Slovenia - managed by CRO
    Zagreb, 10000, Croatia
  • Department of Dermatology and Allergy, University of Bonn
    Bonn, 53105, Germany
  • Czech Republic - managed by CRO
    Warszawa, 02-019, Poland
  • Hungary - managed by CRO
    Warszawa, 02-019, Poland
  • Latvia - managed by CRO
    Warszawa, 02-019, Poland
  • Poland - managed by CRO
    Warszawa, 02-019, Poland
  • Belgium - managed by CRO
    Warszawa, Poland
  • The Netherlands - managed by CRO
    Warszawa, Poland
  • Serbia - managed by CRO
    New Belgrade, 11070, Serbia
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00691002
Lead sponsor
LEO Pharma
Responsible party
Sponsor
First posted
Jun 5, 2008
Start date
May 2008
Primary completion
Jan 2010
Completion
Jan 2010
Results posted
Aug 26, 2021
Last update
Mar 10, 2025

Study contacts

Thomas Bieber, MD
principal investigator · Department of Dermatology and Allergy, University of Bonn

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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