Psoriasis VulgarisPhase 2NCT02387853

Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis

A Phase 2 study testing LEO 90100 in people with Psoriasis Vulgaris, run by LEO Pharma at 9 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Psoriasis Vulgaris
What is being tested?: LEO 90100
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 9 sitesin 4 countries
Study dates: Mar 2016to 28 Mar 2018
Phase: Phase 2
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 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA.
Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area.
A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
PGA score of at least mild on scalp at SV1, SV2 and V1.
A serum albumin-corrected calcium below the upper reference limit at SV2.

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Inclusion Criteria (for subjects performing HPA axis assessment)
Psoriasis vulgaris on trunk and/or limbs affecting at least 10% BSA.
Psoriasis vulgaris on the scalp affecting at least 20% of total scalp area.
PGA score of at least moderate on trunk and limbs at SV1, SV2 and V1.
PGA score of at least moderate on scalp at SV1, SV2 and V1.
Normal HPA axis function at SV2 (serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge).

Who cannot join

A history of hypersensitivity to any component of LEO 90100.
Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:
etanercept - within 4 weeks prior to V1
adalimumab, infliximab - within 2 months prior to V1
ustekinumab - within 4 months prior to V1
experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to V1

Show all 14Show fewer

Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
PUVA therapy within 4 weeks prior to V1.
UVB therapy within 2 weeks prior to V1 or during the trial.
Exclusion Criteria (for subjects performing HPA axis assessment):
A history of serious allergy, allergic asthma or serious allergic skin rash.
Known or suspected hypersensitivity to any component of CORTROSYN® (including ACTH/cosyntropin/tetracosactide)
Systemic treatment with corticosteroids (including inhaled and nasal steroids) within 12 weeks prior to SV2 or during the trial.
Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.

Trial locations and contacts

9 sites in 4 countries.

Country

City, postcode or hospital

9 sites in 4 countries

United States6 sites

Dermatology Treatment and Research Center PA
Dallas, Texas, 75230-5808
Hamzavi Dermatology
Fort Gratiot, Michigan, 48059-3526
Greenwich Village Dermatology
New York, New York, 10012
Skin Speciality Dermatology
New York, New York, 10155
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, 94304
Redwood Family Dermatology
Santa Rosa, California, 95403-2805

Other trials in United States

Netherlands1 site

UMC St Radboud
Nijmegen, 6525

Other trials in Netherlands

Poland1 site

MULTIKLINIKA SALUTE Sp zo.o.
Katowice, 40-123

Other trials in Poland

Romania1 site

Spitalul Clinic de Boli Infectioase si Tropicale
Bucharest, 030303

Other trials in Romania

About this study

Official title: Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis

An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.

Conditions: Psoriasis Vulgaris
Being tested: LEO 90100

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LEO 90100Drug

Study groups in NCT02387853
Study group	Role	What they receive
LEO 90100	Experimental	Not described Receives: Drug: LEO 90100

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Adverse Events (AEs)
Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Measured: From Week -1 to Week 8
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Measured: 30 minutes after ACTH-challenge at Week 4
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Measured: From baseline to Week 4
Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Measured: From baseline to Week 4
Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
Measured: From baseline to Week 4

Secondary outcomes (8)

Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Measured: 30 and 60 minutes after ACTH-challenge at Week 4
Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4
Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing.
Measured: From baseline to Week 4
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body
Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Measured: Week 4
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp
Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Measured: Week 4
Percentage Change in PASI From Baseline to Week 4
Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
Measured: From baseline to Week 4
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4
Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Measured: Week 4
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4
Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Measured: Week 4
Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4
Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome.
Measured: From baseline to Week 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 201628 Mar 2018

First posted13 Mar 2015 (estimated)
Study startMar 2016
Primary completion28 Mar 2018
Study completion28 Mar 2018

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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02387853
Sponsor's protocol ID: LP0053-1108
Status last verified: Jan 2019
First submitted: 12 Mar 2015
Last updated: 10 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Psoriasis Vulgaris trials

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: Safety and Effect of LEO 90100 Aerosol Foam on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to < 17 Years) With Plaque Psoriasis
ClinicalTrials.gov ID: NCT02387853
Acronym / sponsor ID: LP0053-1108
Conditions: Psoriasis Vulgaris
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Mar 2016 (actual)
Primary completion: 28 Mar 2018 (actual)
Study completion: 28 Mar 2018 (actual)
First posted: 13 Mar 2015 (estimated)
Results: Posted 15 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LEO 90100	Experimental	Drug: LEO 90100

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (12 listed)

Psoriasis vulgaris on trunk and/or limbs affecting at least 2% BSA.
Psoriasis vulgaris on the scalp affecting at least 10% of total scalp area.
A total psoriatic involvement on trunk, limbs and scalp not exceeding 30% BSA.
PGA score of at least mild on trunk and/or limbs at SV1, SV2 and V1.
PGA score of at least mild on scalp at SV1, SV2 and V1.

Key exclusion criteria (14 listed)

A history of hypersensitivity to any component of LEO 90100.
Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp and/or body psoriasis within the following time period prior to V1 and during the trial:
Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g. methotrexate, retinoids, immunosuppressants) within 4 weeks prior to V1 or during the trial.
PUVA therapy within 4 weeks prior to V1.
UVB therapy within 2 weeks prior to V1 or 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
LEO 90100	Drug	LEO 90100

Primary outcome

Number of Subjects With Adverse Events (AEs)
Time frame: From Week -1 to Week 8
Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Time frame: 30 minutes after ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
Time frame: From baseline to Week 4
Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
Time frame: From baseline to Week 4
Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
Time frame: From baseline to Week 4
Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.

8 secondary outcomes

Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Time frame: 30 and 60 minutes after ACTH-challenge at Week 4
Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4
Time frame: From baseline to Week 4
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body
Time frame: Week 4
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp
Time frame: Week 4
Percentage Change in PASI From Baseline to Week 4
Time frame: From baseline to Week 4
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4
Time frame: Week 4
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4
Time frame: Week 4
Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4
Time frame: From baseline to Week 4

Results and safety

Results posted to the registry on 15 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LEO 90100	106	103

Primary outcome: Number of Subjects With Adverse Events (AEs)

Time frame: From Week -1 to Week 8. Count of participants. Unit: Participants

Measure	LEO 90100 n = 106
Upper respiratory tract infection	8
Nasopharyngitis	4
Folliculitis	1
Impetigo	1
Oral herpes	1
Pharyngitis	1
Pulpitis dental	1
Rhinitis	1

Population analysed: Safety analysis set

Primary outcome: Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4

Time frame: 30 minutes after ACTH-challenge at Week 4. Count of participants. Unit: Participants

Measure	LEO 90100 n = 33
Serum cortisol equal to or below 18 mcg/dl	3
Serum cortisol above 18 mcg/dl	30

Population analysed: Per protocol analysis set

Primary outcome: Change in Albumin-corrected Serum Calcium From Baseline to Week 4

Time frame: From baseline to Week 4. Mean (Standard Deviation). Unit: mmol/L

Measure	LEO 90100 n = 101
Value	-0.016 (0.119)

Population analysed: Safety analysis set

Primary outcome: Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4

Time frame: From baseline to Week 4. Mean (Standard Deviation). Unit: mmol/24hr

Measure	LEO 90100 n = 32
Value	-0.335 (2.076)

Population analysed: 24-hour urine HPA set

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From Day -28 up to Day 56. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LEO 90100	0 of 106 (0%)	22 of 106 (20.8%)	0 of 106

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

Related trials for Psoriasis Vulgaris

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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.

M Seyger, MD principal investigator

UMC St Radboud

9 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LEO 90100 in people with Psoriasis Vulgaris, run by LEO Pharma at 9 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 12 inclusion and 14 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 9 sites in United States, Netherlands, Poland, Romania. 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. 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?

Yes. Results are posted in the registry (first posted 15 Jan 2019). 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?

Number of Subjects With Adverse Events (AEs) (time frame: From Week -1 to Week 8). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02387853.

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.