Psoriasis VulgarisPhase 3NCT00691002
Efficacy and Safety of Calcipotriol Plus Hydrocortisone Ointment in Psoriasis Vulgaris on the Face and Skin Folds
A Phase 3 study testing Calcipotriol plus hydrocortisone (LEO 80190), Hydrocortisone and Calcipotriol in people with Psoriasis Vulgaris, run by LEO Pharma at 11 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Calcipotriol plus hydrocortisone (LEO 80190), Hydrocortisone and Calcipotriol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,245 participants
- Where
- 11 sitesin 4 countries
- Study dates
- May 2008to Jan 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
11 sites in 4 countries.
11 sites in 4 countries
Poland6 sites
Czech Republic - managed by CRO
Warsaw, 02-019
Hungary - managed by CRO
Warsaw, 02-019
Latvia - managed by CRO
Warsaw, 02-019
Poland - managed by CRO
Warsaw, 02-019
Belgium - managed by CRO
Warsaw
The Netherlands - managed by CRO
Warsaw
Croatia3 sites
Croatia - managed by CRO
Zagreb, 10000
Macedonia - managed by CRO
Zagreb, 10000
Slovenia - managed by CRO
Zagreb, 10000
Germany1 site
Department of Dermatology and Allergy, University of Bonn
Bonn, 53105
About this study
Official title: Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas
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
- Being tested
- Calcipotriol plus hydrocortisone (LEO 80190), LEO 80190 Vehicle, Hydrocortisone, Calcipotriol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcipotriol plus hydrocortisone (LEO 80190)Drug
Once daily application
LEO 80190 VehicleDrug
HydrocortisoneDrug
CalcipotriolDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 80190 | Experimental | Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) Receives: Drug: Calcipotriol plus hydrocortisone (LEO 80190) |
| LEO 80190 vehicle | Placebo comparator | Ointment Vehicle Receives: Drug: LEO 80190 Vehicle |
| Calcipotriol | Active comparator | Calcipotriol 25 mcg/g in the ointment vehicle Receives: Drug: Calcipotriol |
| Hydrocortisone | Active comparator | Hydrocortisone 10 mg/g in the ointment vehicle Receives: Drug: Hydrocortisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
"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
Measured: 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
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.
Measured: 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
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
- = mild
- = moderate
- = severe
- = very severe
Thickness 0 = none
- = mild
- = moderate
- = severe
- = very severe
Scaliness 0 = none
- = mild
- = moderate
- = severe
- = 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.
Measured: At Week 8 (end of treatment for double-blind phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,245 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Bieber, MD, Principal investigator, Department of Dermatology and Allergy, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00691002
- Sponsor's protocol ID
- LEO 80190-O21
- Status last verified
- Aug 2021
- First submitted
- 3 Jun 2008
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcipotriol Plus Hydrocortisone in Psoriasis Vulgaris on the Face and on the Intertriginous Areas
- ClinicalTrials.gov ID
- NCT00691002
- Acronym / sponsor ID
- LEO 80190-O21
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,245 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 5 Jun 2008 (estimated)
- Results
- Posted 26 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LEO 80190 | Experimental | Drug: Calcipotriol plus hydrocortisone (LEO 80190)Calcipotriol 25 mcg/g plus 10 mg/g hydrocortisone ointment (LEO 80190) |
| LEO 80190 vehicle | Placebo comparator | Drug: LEO 80190 VehicleOintment Vehicle |
| Calcipotriol | Active comparator | Drug: CalcipotriolCalcipotriol 25 mcg/g in the ointment vehicle |
| Hydrocortisone | Active comparator | Drug: HydrocortisoneHydrocortisone 10 mg/g in the ointment vehicle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcipotriol plus hydrocortisone (LEO 80190)Once daily application | Drug | LEO 80190 |
| LEO 80190 Vehicle | Drug | LEO 80190 vehicle |
| Hydrocortisone | Drug | Hydrocortisone |
| Calcipotriol | Drug | Calcipotriol |
Primary outcome
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
Time frame: At Week 8 (end of treatment for 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.
4 secondary outcomes
Participants With "Controlled Disease" According to the IGA of Disease Severity of the Face at Week 4 (Visit 4) in the Double-blind Phase
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At Week 8 (end of treatment for double-blind phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Bieber, MD principal investigator
Department of Dermatology and Allergy, University of Bonn
11 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Calcipotriol plus hydrocortisone (LEO 80190), Hydrocortisone and Calcipotriol in people with Psoriasis Vulgaris, run by LEO Pharma at 11 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, Croatia, Germany, Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: At Week 8 (end of treatment for double-blind phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.