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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- LEO Pharma
- Enrollment
- 125
- Locations
- 35
- Primary Endpoint
- Change in Albumin-corrected Serum Calcium From Baseline to Week 8
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
LEO 80185 gel
Intervention: LEO 80185 gel (Drug)
Outcomes
Primary Outcomes
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 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.
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
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
Adverse Drug Reactions (ADRs)
Time Frame: 8 weeks
Number of Adverse Drug Reactions (ADRs)
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
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
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
Secondary Outcomes
- Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 8(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)
- Percentage Change in PASI From Baseline to End of Treatment(From baseline to end of treatment)
- 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)
- 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)
- Change in Serum Alkaline Phosphatase From Baseline to Week 4(From baseline to Week 4)
- Adverse Events (AEs)(8 weeks)
- Change in Urinary Calcium:Creatinine Ratio From Baseline to Week 4(From baseline to Week 4)
- Change in Serum Alkaline Phosphatase From Baseline to Week 8(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)
- Pharmacokinetic Evaluation AUC(0-infinity)(Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP)
- Pharmacokinetic Evaluation T(½)(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(End of treatment)
- Subjects With "Controlled Disease" According to the Patient's Global Assessment of Disease Severity on the Body at End of Treatment(End of treatment)
- Pharmacokinetic Evaluation T(Max)(Week 4, blood samples taken before IMP was applied and 1, 3, and 5 hours after application of IMP)