Psoriasis VulgarisPhase 2NCT02038569
An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects
A Phase 2 study testing LEO 80185 gel in people with Psoriasis Vulgaris, run by LEO Pharma at 35 sites in 7 countries.
Trial summary
An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body 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 80185 gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 35 sitesin 7 countries
- Study dates
- Jan 2014to 13 Feb 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
- Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs)
- At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs) psoriasis which is:
- of an extent of 10 to 35% of the body surface area (excluding psoriatic lesions of the face and sensitive areas. Sensitive areas include armpits, groin, under the breasts and in other skin folds around the genitals and buttocks), and
- of at least moderate severity according to the investigator's global assessment of disease severity on the body.
- A serum albumin-corrected calcium level below the upper reference limit at SV2
- Inclusion Criteria (for subjects performing HPA axis assessments):
Show all 14Show fewer
- At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- more than or equal to 20% of the scalp area, and
- of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.
- Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge.
- Inclusion Criteria (for subjects not performing HPA axis assessments):
- At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- more than or equal to 10% of the scalp area, and
- of at least moderate severity according to the investigator's global assessment of disease severity on the scalp.
Who cannot join
- 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 Visit 1 and during the trial:
- etanercept - within 4 weeks prior to Visit 1
- adalimumab, infliximab - within 2 months prior to Visit 1
- ustekinumab - within 4 months prior to Visit 1
- experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
- Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial.
Show all 39Show fewer
- UVB therapy within 2 weeks prior to Visit 1 or during the trial.
- Any topical treatment on the scalp and body (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.
- Systemic calcium, vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 or during the trial.
- Planned initiation of, or changes to, concomitant medication that could affect psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the trial.
- Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
- Subjects with any of the following conditions present on the treatment areas on scalp and/or body: 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, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds.
- Other inflammatory skin diseases that may confound the evaluation of scalp and/or body psoriasis.
- Planned excessive exposure to sun during the trial that may affect scalp and/or body psoriasis.
- Known or suspected severe renal insufficiency or severe hepatic disorders.
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
- Any clinically significant abnormality following review of screening laboratory tests (blood and urine samples), physical examination or blood pressure/heart rate measurement performed at SV2.
- Current participation in any other interventional clinical trial.
- Previously enrolled in this trial.
- Subjects who have received treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within a month prior to SV1 or longer, if the class of substance required a longer wash-out as defined above (e.g., biological treatments).
- Subjects or parent(s) or legal guardian known or suspected of being unlikely to comply with the Clinical Trial Protocol (e.g., alcoholism, drug dependency or psychotic state).
- Females who are pregnant, or of child-bearing potential and wishing to become pregnant during the trial, or who are breast-feeding.
- Females of child-bearing potential with positive pregnancy test at SV2.
- Subject (or their partner) not using an adequate method of contraception according to national requirements.
- Exclusion Criteria (for subjects performing HPA axis assessments)
- 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.
- Topical treatment with corticosteroids within 2 weeks prior to SV2 or during the trial.
- Oestrogen therapy (including contraceptives) or any other medication known to affect cortisol levels levels or HPA axis integrity within 4 weeks prior to SV2 or during the trial.
- Enzymatic inductors (e.g., barbiturates, phenytoin, rifampicin) within 4 weeks prior to SV2 or during the trial.
- Systemic or topical cytochrome P450 inhibitors (e.g., ketoconazole, itraconazole, metronidazole) within 4 weeks prior to SV2 or during the trial. Topical ketoconazole 2 weeks prior to SV2.
- Hypoglycemic sulfonamides within 4 weeks prior to SV2 or during the trial.
- Antidepressive medications within 4 weeks prior to SV2 or during the trial.
- Known or suspected endocrine disorder that may affect the results of the ACTH challenge test.
- Clinical signs or symptoms of Cushing's disease or Addison's disease.
- Subjects with diabetes mellitus.
- Known or suspected cardiac condition.
- Not following nocturnal sleep patterns.
Trial locations and contacts
35 sites in 7 countries.
35 sites in 7 countries
United States8 sites
Dermatology and Laser Center of Charleston, PA
Charleston, South Carolina, 29407
St. Luke's Roosevelt Hospital
Forest Hills, New York, 10025
Indiana University
Indianapolis, Indiana, 46202
Clinical Partners
Johnston, Rhode Island, 12095
Skin Specialists, PC
Omaha, Nebraska, 68144
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Rady's Children Hospital
San Diego, California, 92132
Clinical Research Center, Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
Romania7 sites
Policlinica de Diagnostic Rapid S.A. Clinic
Brasov, 500152
Spitalul Clinic "Colentina"
Bucharest, 20125
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, 400006
Cabinet Medical Individual Tatu G. Alin Laurentiu
Galati, 800101
Iasiprest SRL Dermato-Venerology
Iași, 700381
Spitalul Clinic Judetean Mures
Târgu Mureş, 800373
Spitalul Clinic Municipal de Urgenta Timisoara
Timișoara, 300077
Poland5 sites
Endo - Med. Centrum Medyczne Clinic
Karczew, 05-480
NZOZ Med.-Laser Clinic
Lublin, 20-146
Specjalistyczny Ofrodek Leczniczo Clinic
Ostróda, 14-100
Medycyna Kliniczna Clinic
Warsaw, 00-660
Derm Medica Sp.zo.o. Clinic
Wroclaw, 51-318
Canada4 sites
Lynderm Research Inc.
Markham, Ontario, L3P 1A8
Skin Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
Adult, Pediatric and Laser Derma
St. John's, Newfoundland and Labrador, A1A 4Y3
Winnipeg Clinic
Winnipeg, Manitoba, R3C 0N2
Germany4 sites
Charite Berlin
Berlin, 10117
Uniklinik Bonn
Bonn, 53127
Uniklinik Frankfurt
Frankfurt am Main, 60590
Katholisches Kinderkrankenhaus
Hamburg, 22149
United Kingdom4 sites
Monklands Hospital
Airdrie, Lanarkshire, ML6 OJ5
Whipps Cross University Hospital
Leytonstone, London, E11 1NR
Manchester Royal Infirmary
Manchester, Greater Manchester, M13 9WL
St. Woolos Hospital
Stow Hill, Newport, Monmouthshire, NP20 4SZ
France3 sites
Cabinet Medical
Martigues, Bouches-du-Rhône, 13500
CHU de Nice
Nice, Alpe-Maritimes, 06202
CHI de Cornouaille
Quimper, Finistère, 29107
About this study
Official title: Effect of Calcipotriol Plus Betamethasone Dipropionate Gel on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 16 Years, 11 Months) With Scalp and Body Psoriasis
An international, multi-centre, prospective, non-controlled, open, single-group, 8-week trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
Read the detailed description
A phase 2 trial evaluating the safety and efficacy of once daily use of LEO 80185 gel containing calcipotriol 50 mcg/g plus betamethasone 0.5mg/g (as dipropionate) in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 80185 gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 80185 gelDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 80185 gel | Experimental | Not described Receives: Drug: LEO 80185 gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Drug Reactions (ADRs)
Number of Adverse Drug Reactions (ADRs)
Measured: 8 weeks
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
Measured: 30 minutes after ACTH-challenge at Week 4
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8
Measured: 30 minutes after ACTH-challenge at Week 8
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
Change in albumin-corrected serum calcium from baseline to Week 4
Measured: From baseline to Week 4
Change in Albumin-corrected Serum Calcium From Baseline to Week 8
Change in albumin-corrected serum calcium from baseline to Week 8
Measured: From baseline to Week 8
Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment
Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
Measured: From baseline to end of treatment
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
Change in 24-hour urinary calcium excretion from baseline to Week 4
Measured: From baseline to Week 4
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
Change in 24-hour urinary calcium excretion from baseline to Week 8
Measured: From baseline to Week 8
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
Measured: From baseline to end of treatment
Secondary outcomes (15)
Adverse Events (AEs)
Number of Adverse Events (AEs)
Measured: 8 weeks
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 4
Measured: 30 and 60 minutes after ACTH-challenge at Week 4
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at both 30 and 60 minutes after ACTH-challenge at Week 8
Measured: 30 and 60 minutes after ACTH-challenge at Week 8
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
Change in urinary calcium:creatinine ratio from baseline to Week 4
Measured: From baseline to Week 4
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
Change in urinary calcium:creatinine ratio from baseline to Week 8
Measured: From baseline to Week 8
Change in Serum Alkaline Phosphatase From Baseline to Week 4
Change in serum alkaline phosphatase from baseline to Week 4
Measured: From baseline to Week 4
Change in Serum Alkaline Phosphatase From Baseline to Week 8
Change in serum alkaline phosphatase from baseline to Week 8
Measured: From baseline to Week 8
Pharmacokinetic Evaluation AUC(0-t)
AUC(0-t) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-t) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-t). The mean value of AUC(0-t) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
Measured: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation AUC(0-infinity)
AUC(0-infinity) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects, and no subjects had enough positive samples to allow calculation AUC(0-infinity) for betamethasone dipropionate. Betamethasone 17-propionate was only detected in 12 samples from 5 subjects, and only 2 subjects had enough positive samples to calculate AUC(0-infinity). The mean value of AUC(0-infinity) for these 2 subjects is presented for betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
The terms AUC(0-infinity) and AUC(all) are interchangeable, AUC(0-infinity) was used in the protocol whereas AUC(all) was used in the report. AUC(0-infinity) has been used here to be consistent with the protocol.
Measured: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation C(Max)
C(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore pharmacokinetic profiles could not be calculated. Presented C(max) values for betamethasone dipropionate and betamethasone 17-propionate are the the single highest concentrations measured in any sample at any time. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
Measured: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation T(Max)
T(max) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects. Therefore it was not possible to calculate T(max) for betamethasone dipropionate and betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
Measured: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation T(½)
T(½) values for betamethasone dipropionate, betamethasone 17-propionate, calcipotriol, and MC1080. Betamethasone dipropionate was only detected above lower limit of quantification in 5 samples from 4 subjects and betamethasone 17-propionate was only detected in 12 samples from 5 subjects, therefore it was not possible to calculate T(½) for betamethasone dipropionate or betamethasone 17-propionate. Calcipotriol and MC1080 were never detected above lower limit of quantification, therefore no PK parameters could be calculated and no data have been entered for calcipotriol and MC1080.
Measured: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment
Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the investigator's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.
Measured: End of treatment
Percentage Change in PASI From Baseline to End of Treatment
Percentage change in Psoriasis area and severity index (PASI) score from baseline to end of treatment, defined as the last value recorded up to and including Week 8. 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 end of treatment
Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment
Subjects with "Controlled disease" (i.e., "Clear" or "Almost clear" for subjects with at least "Moderate" disease at baseline, "Clear" for subjects with "Mild" disease at baseline) according to the patient's global assessment of disease severity on the body at end of treatment, defined as the last value recorded up to and including Week 8.
Measured: End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2018
- Study completion13 Feb 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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Eichenfield, MD, Principal investigator, Rady Chilidren's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038569
- Sponsor's protocol ID
- LP0076-1017
- Status last verified
- Oct 2018
- First submitted
- 13 Jan 2014
- 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
- Effect of Calcipotriol Plus Betamethasone Dipropionate Gel on the HPA Axis and Calcium Metabolism in Adolescent Subjects (Aged 12 to 16 Years, 11 Months) With Scalp and Body Psoriasis
- ClinicalTrials.gov ID
- NCT02038569
- Acronym / sponsor ID
- LP0076-1017
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Posted 6 Nov 2018
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, non-controlled, open, single-group, 8-week trial in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body psoriasis.
Detailed description
A phase 2 trial evaluating the safety and efficacy of once daily use of LEO 80185 gel containing calcipotriol 50 mcg/g plus betamethasone 0.5mg/g (as dipropionate) in adolescent subjects (aged 12 to 16 years, 11 months) with scalp and body 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 80185 gel | Experimental | Drug: LEO 80185 gel |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Clinical signs of psoriasis vulgaris on both the scalp and body (trunk and/or limbs)
- At SV2 and Visit 1, a clinical diagnosis of scalp and body (trunk and/or limbs) psoriasis which is:
- A serum albumin-corrected calcium level below the upper reference limit at SV2
- At SV2 and Visit 1, a clinical diagnosis of scalp psoriasis which is:
- Subjects with a normal HPA axis function at SV2 including serum cortisol concentration above 5 mcg/dl before ACTH challenge and serum cortisol concentration above 18 mcg/dl 30 minutes after ACTH challenge.
Key exclusion criteria (39 listed)
- 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 Visit 1 and during the trial:
- Systemic treatment with therapies other than biologicals, with a possible effect on scalp and/or body psoriasis (e.g., retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the trial.
- UVB therapy within 2 weeks prior to Visit 1 or during the trial.
- Any topical treatment on the scalp and body (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the trial.
- Systemic calcium, vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to SV2 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 80185 gel | Drug | LEO 80185 gel |
Primary outcome
Adverse Drug Reactions (ADRs)
Time frame: 8 weeks
Number of Adverse Drug Reactions (ADRs)
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
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8
Time frame: 30 minutes after ACTH-challenge at Week 8
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 8
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
Change in Albumin-corrected Serum Calcium From Baseline to Week 8
Time frame: From baseline to Week 8
Change in albumin-corrected serum calcium from baseline to Week 8
Change in Albumin-corrected Serum Calcium From Baseline to End of Treatment
Time frame: From baseline to end of treatment
Change in albumin-corrected serum calcium from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4
Time frame: From baseline to Week 4
Change in 24-hour urinary calcium excretion from baseline to Week 4
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8
Time frame: From baseline to Week 8
Change in 24-hour urinary calcium excretion from baseline to Week 8
Change in 24-hour Urinary Calcium Excretion From Baseline to End of Treatment
Time frame: From baseline to end of treatment
Change in 24-hour urinary calcium excretion from baseline to end of treatment, defined as the last value recorded after baseline up to and including Week 8.
15 secondary outcomes
Adverse Events (AEs)
Time frame: 8 weeks
Subjects With Serum Cortisol Concentration of ≤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
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8
Time frame: 30 and 60 minutes after ACTH-challenge at Week 8
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4
Time frame: From baseline to Week 4
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8
Time frame: From baseline to Week 8
Change in Serum Alkaline Phosphatase From Baseline to Week 4
Time frame: From baseline to Week 4
Change in Serum Alkaline Phosphatase From Baseline to Week 8
Time frame: From baseline to Week 8
Pharmacokinetic Evaluation AUC(0-t)
Time frame: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation AUC(0-infinity)
Time frame: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation C(Max)
Time frame: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation T(Max)
Time frame: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Pharmacokinetic Evaluation T(½)
Time frame: Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment
Time frame: End of treatment
Percentage Change in PASI From Baseline to End of Treatment
Time frame: From baseline to end of treatment
Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment
Time frame: End of treatment
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.
Lawrence Eichenfield, MD principal investigator
Rady Chilidren's Hospital
35 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 80185 gel in people with Psoriasis Vulgaris, run by LEO Pharma at 35 sites in 7 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 14 inclusion and 39 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 35 sites in United States, Romania, Poland, Canada, Germany and 2 more countries. 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 6 Nov 2018). 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?
Adverse Drug Reactions (ADRs) (time frame: 8 weeks). The study lists 9 primary outcomes in all. 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.