An International, Multi-centre, Prospective, Non-controlled, Open, Single-group, 8-week Trial in Adolescent Subjects
- Conditions
- Psoriasis Vulgaris
- Interventions
- Drug: LEO 80185 gel
- Registration Number
- NCT02038569
- Lead Sponsor
- LEO Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description LEO 80185 gel LEO 80185 gel -
- Primary Outcome Measures
Name Time Method Change in Albumin-corrected Serum Calcium From Baseline to Week 8 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 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 Albumin-corrected Serum Calcium From Baseline to Week 4 From baseline to Week 4 Change in albumin-corrected serum calcium from baseline to Week 4
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 8 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 24-hour Urinary Calcium Excretion From Baseline to End of Treatment 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.
Adverse Drug Reactions (ADRs) 8 weeks Number of Adverse Drug Reactions (ADRs)
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 8 From baseline to Week 8 Change in 24-hour urinary calcium excretion from baseline to Week 8
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4 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
Change in 24-hour Urinary Calcium Excretion From Baseline to Week 4 From baseline to Week 4 Change in 24-hour urinary calcium excretion from baseline to Week 4
- Secondary Outcome Measures
Name Time Method Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8 From baseline to Week 8 Change in urinary calcium:creatinine ratio from baseline to Week 8
Pharmacokinetic Evaluation C(Max) Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP 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.
Percentage Change in PASI From Baseline to End of Treatment 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.
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 4 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
Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at Both 30 and 60 Minutes After ACTH-challenge at Week 8 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
Change in Serum Alkaline Phosphatase From Baseline to Week 4 From baseline to Week 4 Change in serum alkaline phosphatase from baseline to Week 4
Adverse Events (AEs) 8 weeks Number of Adverse Events (AEs)
Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4 From baseline to Week 4 Change in urinary calcium:creatinine ratio from baseline to Week 4
Change in Serum Alkaline Phosphatase From Baseline to Week 8 From baseline to Week 8 Change in serum alkaline phosphatase from baseline to Week 8
Pharmacokinetic Evaluation AUC(0-t) Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP 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.
Pharmacokinetic Evaluation AUC(0-infinity) Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP 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.Pharmacokinetic Evaluation T(½) Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP 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.
Subjects With "Controlled Disease" According to the Investigator's Global Assessment of Disease Severity on the Body at End of Treatment 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.
Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment 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.
Pharmacokinetic Evaluation T(Max) Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP 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.
Trial Locations
- Locations (35)
Charite Berlin
🇩🇪Berlin, Germany
Rady's Children Hospital
🇺🇸San Diego, California, United States
Clinical Research Center, Morsani Center for Advanced Healthcare
🇺🇸Tampa, Florida, United States
Skin Specialists, PC
🇺🇸Omaha, Nebraska, United States
Clinical Partners
🇺🇸Johnston, Rhode Island, United States
St. Luke's Roosevelt Hospital
🇺🇸Forest Hills, New York, 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
Cabinet Medical
🇫🇷Martigues, Bouches-du-Rhône, France
CHI de Cornouaille
🇫🇷Quimper, Finistère, France
Katholisches Kinderkrankenhaus
🇩🇪Hamburg, Germany
Uniklinik Bonn
🇩🇪Bonn, Germany
Uniklinik Frankfurt
🇩🇪Frankfurt am Main, Germany
NZOZ Med.-Laser Clinic
🇵🇱Lublin, Poland
Medycyna Kliniczna Clinic
🇵🇱Warszawa, Poland
Manchester Royal Infirmary
🇬🇧Manchester, Greater Manchester, United Kingdom
Whipps Cross University Hospital
🇬🇧Leytonstone, London, United Kingdom
CHU de Nice
🇫🇷Nice, Alpe-Maritimes, France
Iasiprest SRL Dermato-Venerology
🇷🇴Iasi, 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
Endo - Med. Centrum Medyczne Clinic
🇵🇱Karczew, Poland
Specjalistyczny Ofrodek Leczniczo Clinic
🇵🇱Ostróda, Poland
Derm Medica Sp.zo.o. Clinic
🇵🇱Wrocław, Poland
Policlinica de Diagnostic Rapid S.A. Clinic
🇷🇴Brasov, Romania
Spitalul Clinic Municipal de Urgenta Timisoara
🇷🇴Timisoara, Romania
St. Woolos Hospital
🇬🇧Stow Hill, Newport, Monmouthshire, United Kingdom
Spitalul Clinic Judetean Mures
🇷🇴Targu-Mures, Romania
Indiana University
🇺🇸Indianapolis, Indiana, United States
Monklands Hospital
🇬🇧Airdrie, Lanarkshire, United Kingdom