Last reviewed · How we verify
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.
Details
| Lead sponsor | LEO Pharma |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 125 |
| Start date | 2014-01 |
| Completion | 2018-02-13 |
Conditions
- Psoriasis Vulgaris
Interventions
- LEO 80185 gel
Primary outcomes
- Adverse Drug Reactions (ADRs) — 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 — 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 — 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 — 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 — 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.
Countries
United States, Canada, France, Germany, Poland, Romania, United Kingdom