An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects

NCT ID: NCT02038569

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2018-02-13

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LEO 80185 gel

Group Type: EXPERIMENTAL

LEO 80185 gel

Intervention Type: DRUG

Interventions

LEO 80185 gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• 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.

Exclusion Criteria

• 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.
• 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.

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lawrence Eichenfield, MD

Role: PRINCIPAL_INVESTIGATOR

Rady Chilidren's Hospital

Locations

Rady's Children Hospital

San Diego, California, United States

Clinical Research Center, Morsani Center for Advanced Healthcare

Tampa, Florida, United States

Indiana University

Indianapolis, Indiana, United States

Skin Specialists, PC

Omaha, Nebraska, United States

St. Luke's Roosevelt Hospital

Forest Hills, New York, United States

Clinical Partners

Johnston, Rhode Island, United States

Dermatology and Laser Center of Charleston, PA

Charleston, South Carolina, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Winnipeg Clinic

Winnipeg, Manitoba, Canada

Adult, Pediatric and Laser Derma

St. John's, Newfoundland and Labrador, Canada

Lynderm Research Inc.

Markham, Ontario, Canada

Skin Centre for Dermatology

Peterborough, Ontario, Canada

CHU de Nice

Nice, Alpe-Maritimes, France

Cabinet Medical

Martigues, Bouches-du-Rhône, France

CHI de Cornouaille

Quimper, Finistère, France

Charite Berlin

Berlin, , Germany

Uniklinik Bonn

Bonn, , Germany

Uniklinik Frankfurt

Frankfurt am Main, , Germany

Katholisches Kinderkrankenhaus

Hamburg, , Germany

Endo - Med. Centrum Medyczne Clinic

Karczew, , Poland

NZOZ Med.-Laser Clinic

Lublin, , Poland

Specjalistyczny Ofrodek Leczniczo Clinic

Ostróda, , Poland

Medycyna Kliniczna Clinic

Warsaw, , Poland

Derm Medica Sp.zo.o. Clinic

Wroclaw, , Poland

Policlinica de Diagnostic Rapid S.A. Clinic

Brasov, , Romania

Spitalul Clinic "Colentina"

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, , Romania

Cabinet Medical Individual Tatu G. Alin Laurentiu

Galati, , Romania

Iasiprest SRL Dermato-Venerology

Iași, , Romania

Spitalul Clinic Judetean Mures

Târgu Mureş, , Romania

Spitalul Clinic Municipal de Urgenta Timisoara

Timișoara, , Romania

Manchester Royal Infirmary

Manchester, Greater Manchester, United Kingdom

Monklands Hospital

Airdrie, Lanarkshire, United Kingdom

Whipps Cross University Hospital

Leytonstone, London, United Kingdom

St. Woolos Hospital

Stow Hill, Newport, Monmouthshire, United Kingdom

Countries

United States; Canada; France; Germany; Poland; Romania; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

LP0076-1017

Identifier Type: -

Identifier Source: org_study_id