Skin and Connective Tissue DiseasesPhase 2LP0113-1123NCT02416258
A Psoriasis Plaque Test Trial With LP0113 Spray in Patients With Psoriasis Vulgaris (LP0113-1123)
A Phase 2 study testing LP0113 aerosol spray, LEO 90100 aerosol foam and Betamethasone dipropionate aerosol spray in people with Skin and Connective Tissue Diseases, run by LEO Pharma at 1 site in France.
Trial summary
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skin and Connective Tissue Diseases
- What is being tested?
- LP0113 aerosol spray, LEO 90100 aerosol foam and Betamethasone dipropionate aerosol spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2015to Jun 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Signed and dated informed consent has been obtained
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
- Age 18 years or above
- Outpatients
- Female subjects must be of either
- non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus or has tubal ligation) or,
- child-bearing potential provided there is a confirmed negative pregnancy test prior to trial treatment to rule out pregnancy.
Who cannot join
- Female subjects who are breast feeding
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- Etanercept - within 4 weeks prior to randomisation and during the trial
- Adalimumab, infliximab - within 8 weeks prior to randomisation and during the trial
- Ustekinumab - within 16 weeks prior to randomisation and during the trial
- Other products - within 4 weeks/5 half-lives prior to randomisation and during the trial (whichever is longer)
Show all 18Show fewer
- Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
- Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
- PUVA: 4 weeks
- UVB: 2 weeks
- Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
- Potent or very potent (WHO group III-IV) corticosteroids
- Subjects using one of the following topical drugs for the treatment of psoriasis within 2 weeks prior to randomisation and during the trial:
- WHO group I-II corticosteroids (except if used for treatment of scalp and/or facial psoriasis)
- Topical retinoids, Vitamin D analogues, Topical immunomodulators (e.g. calcineurin inhibitors), Tar products, Salicylic acid
- Subjects using emollients on the selected plaques within 1 week before randomisation and during the trial
- Initiation of, or expected changes to concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, antimalarial drugs, lithium and ACE inhibitors) within 2 weeks prior to the randomisation and during the trial
- Subjects with current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Pharmacologie Clinique Appliquée à la Dermatologie (CPCAD)
Nice, 06000
About this study
Official title: A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.
- Conditions
- Skin and Connective Tissue Diseases
- Being tested
- LP0113 aerosol spray, Aerosol spray vehicle, LEO 90100 aerosol foam, Betamethasone dipropionate aerosol spray, Calcipotriol aerosol spray
- Keywords
- Psoriasis
- Medical subject headings
- Skin and Connective Tissue Diseases, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LP0113 aerosol sprayDrug
Aerosol spray vehicleDrug
LEO 90100 aerosol foamDrug
Betamethasone dipropionate aerosol sprayDrug
Calcipotriol aerosol sprayDrug
Daivobet® gelDrug
| Study group | Role | What they receive |
|---|---|---|
| LP0113 aerosol spray | Active comparator | Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Receives: Drug: Aerosol spray vehicle; Drug: LEO 90100 aerosol foam; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel |
| Aerosol spray vehicle | Placebo comparator | No active ingredient, topical Receives: Drug: LP0113 aerosol spray; Drug: LEO 90100 aerosol foam; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel |
| LEO 90100 aerosol foam | Active comparator | Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Receives: Drug: LP0113 aerosol spray; Drug: Aerosol spray vehicle; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel |
| Betamethasone dipropionate aerosol spray | Active comparator | Betamethasone (as dipropionate) 0.5 mg/g, topical Receives: Drug: LP0113 aerosol spray; Drug: Aerosol spray vehicle; Drug: LEO 90100 aerosol foam; Drug: Calcipotriol aerosol spray; Drug: Daivobet® gel |
| Calcipotriol aerosol spray | Active comparator | Calcipotriol (as monohydrate) 50 mcg/g, topical Receives: Drug: LP0113 aerosol spray; Drug: Aerosol spray vehicle; Drug: LEO 90100 aerosol foam; Drug: Betamethasone dipropionate aerosol spray; Drug: Daivobet® gel |
| Daivobet® gel | Active comparator | Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical Receives: Drug: LP0113 aerosol spray; Drug: Aerosol spray vehicle; Drug: LEO 90100 aerosol foam; Drug: Betamethasone dipropionate aerosol spray; Drug: Calcipotriol aerosol spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)
Measured: End of treatment compared to baseline - 4 weeks
Secondary outcomes (3)
Absolute change in single clinical sign score: erythema, scaling, infiltration
Measured: End of treatment and individual visits compared to baseline - 4 weeks
Absolute Change in Total Clinical Score (TCS)
Measured: Individual visits compared to baseline - 4 weeks
Absolute change in total skin thickness and echo-poor band thickness
Measured: End of treatment compared to baseline - 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin and Connective Tissue DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02416258
- Sponsor's protocol ID
- LP0113-1123
- Other IDs
- 2014-004759-30, 2014
- Acronym
- LP0113-1123
- Status last verified
- May 2017
- First submitted
- 9 Apr 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Trial Evaluating the Anti-psoriatic Effect of LP0113 Aerosol Spray Compared With Its Vehicle and With Daivobet® Gel, LEO 90100 Aerosol Foam, Betamethasone Dipropionate Aerosol Spray and Calcipotriol Aerosol Spray in the Treatment of Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT02416258
- Acronym / sponsor ID
- LP0113-1123 / LP0113-1123
- Conditions
- Skin and Connective Tissue Diseases
- Keywords
- Psoriasis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the anti-psoriatic effect of LP0113 aerosol spray compared to Daivobet® gel, LEO 90100 aerosol foam, betamethasone dipropionate in the aerosol spray vehicle, calcipotriol in the aerosol spray vehicle and aerosol spray vehicle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| LP0113 aerosol spray | Active comparator | Drug: Aerosol spray vehicle, Drug: LEO 90100 aerosol foam, Drug: Betamethasone dipropionate aerosol spray, Drug: Calcipotriol aerosol spray, Drug: Daivobet® gelCalcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical |
| Aerosol spray vehicle | Placebo comparator | Drug: LP0113 aerosol spray, Drug: LEO 90100 aerosol foam, Drug: Betamethasone dipropionate aerosol spray, Drug: Calcipotriol aerosol spray, Drug: Daivobet® gelNo active ingredient, topical |
| LEO 90100 aerosol foam | Active comparator | Drug: LP0113 aerosol spray, Drug: Aerosol spray vehicle, Drug: Betamethasone dipropionate aerosol spray, Drug: Calcipotriol aerosol spray, Drug: Daivobet® gelCalcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical |
| Betamethasone dipropionate aerosol spray | Active comparator | Drug: LP0113 aerosol spray, Drug: Aerosol spray vehicle, Drug: LEO 90100 aerosol foam, Drug: Calcipotriol aerosol spray, Drug: Daivobet® gelBetamethasone (as dipropionate) 0.5 mg/g, topical |
| Calcipotriol aerosol spray | Active comparator | Drug: LP0113 aerosol spray, Drug: Aerosol spray vehicle, Drug: LEO 90100 aerosol foam, Drug: Betamethasone dipropionate aerosol spray, Drug: Daivobet® gelCalcipotriol (as monohydrate) 50 mcg/g, topical |
| Daivobet® gel | Active comparator | Drug: LP0113 aerosol spray, Drug: Aerosol spray vehicle, Drug: LEO 90100 aerosol foam, Drug: Betamethasone dipropionate aerosol spray, Drug: Calcipotriol aerosol sprayCalcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g, topical |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed and dated informed consent has been obtained
- Subjects with a diagnosis of psoriasis vulgaris with lesions located on arms, legs and/or trunk. The lesions must have a total size suitable for application of 6 different products.
- Age 18 years or above
- Outpatients
- Female subjects must be of either
Key exclusion criteria (18 listed)
- Female subjects who are breast feeding
- Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:
- Systemic treatment with all other therapies than biologicals, with a potential effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, immunosuppressants) within the 4-week period prior to randomisation and during the trial,
- Subjects using phototherapy within the following time periods prior to randomisation and during the trial:
- Subjects using one of the following topical drugs for the treatment of psoriasis within the 4 week period prior to randomisation and during the trial:
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 |
|---|---|---|
| LP0113 aerosol spray | Drug | Aerosol spray vehicle, Betamethasone dipropionate aerosol spray, Calcipotriol aerosol spray, Daivobet® gel, LEO 90100 aerosol foam |
| Aerosol spray vehicle | Drug | Betamethasone dipropionate aerosol spray, Calcipotriol aerosol spray, Daivobet® gel, LEO 90100 aerosol foam, LP0113 aerosol spray |
| LEO 90100 aerosol foam | Drug | Aerosol spray vehicle, Betamethasone dipropionate aerosol spray, Calcipotriol aerosol spray, Daivobet® gel, LP0113 aerosol spray |
| Betamethasone dipropionate aerosol spray | Drug | Aerosol spray vehicle, Calcipotriol aerosol spray, Daivobet® gel, LEO 90100 aerosol foam, LP0113 aerosol spray |
| Calcipotriol aerosol spray | Drug | Aerosol spray vehicle, Betamethasone dipropionate aerosol spray, Daivobet® gel, LEO 90100 aerosol foam, LP0113 aerosol spray |
| Daivobet® gel | Drug | Aerosol spray vehicle, Betamethasone dipropionate aerosol spray, Calcipotriol aerosol spray, LEO 90100 aerosol foam, LP0113 aerosol spray |
Primary outcome
Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration)
Time frame: End of treatment compared to baseline - 4 weeks
3 secondary outcomes
Absolute change in single clinical sign score: erythema, scaling, infiltration
Time frame: End of treatment and individual visits compared to baseline - 4 weeks
Absolute Change in Total Clinical Score (TCS)
Time frame: Individual visits compared to baseline - 4 weeks
Absolute change in total skin thickness and echo-poor band thickness
Time frame: End of treatment compared to baseline - 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LP0113 aerosol spray, LEO 90100 aerosol foam and Betamethasone dipropionate aerosol spray in people with Skin and Connective Tissue Diseases, run by LEO Pharma at 1 site in France.
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 7 inclusion and 18 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 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Absolute change in Total Clinical Score (TCS) of clinical signs (sum of erythema, scaling and infiltration) (time frame: End of treatment compared to baseline - 4 weeks). 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 24 Feb 2025.