Completed
PHASE2
INTERVENTIONAL
NCT02387853
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
An international, multi-centre, prospective, open-label, non-controlled, single-group, 4-week trial in adolescent subjects with plaque psoriasis.
Interventions
Name:
LEO 90100
Type:
DRUG
Description:
Primary Outcomes
Measure:
Number of Subjects With Adverse Events (AEs)
TimeFrame:
From Week -1 to Week 8
Description:
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.
Measure:
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
TimeFrame:
30 minutes after ACTH-challenge at Week 4
Description:
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.
Measure:
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
TimeFrame:
From baseline to Week 4
Description:
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.
Measure:
Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
TimeFrame:
From baseline to Week 4
Description:
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.
Measure:
Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
TimeFrame:
From baseline to Week 4
Description:
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.
Trial Information
NCT ID
NCT02387853
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
LEO Pharma
Last Updated
December 15, 2025