Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis
NCT02340169 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 129
Last updated 2023-03-28
Summary
The objective of this study is to evaluate the potential of Topicort® (desoximetasone) Topical Spray, 0.25% to suppress hypothalmic pituitary adrenal axis function. The secondary objectives are to evaluate the efficacy parameters, pharmacokinetics and adverse event profile.
Conditions
Interventions
- DRUG
-
Topicort® (desoximetasone) Topical Spray, 0.25%
Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
Sponsors & Collaborators
-
Sun Pharmaceutical Industries, Inc.
lead INDUSTRY
Principal Investigators
-
Novum Pharmaceutical Research Services · http://www.novumprs.com/contact
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 2 Years
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-01-23
- Primary Completion
- 2019-11-22
- Completion
- 2021-11-22
Countries
- United States
Study Locations
More Related Trials
-
Evaluation of Adrenal Suppression Potential and Pharmacokinetics of Halobetasol Lotion 0.05%
NCT03212963 ·Status: TERMINATED ·Phase: PHASE4
-
Effects of Desoximetasone Spray 0.25% in Patients With Moderate to Severe Plaque Psoriasis
NCT01206660 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Calcitriol BID Topical Treatment in Adolescents With Plaque Psoriasis
NCT00419666 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of 0.25% Desoximetasone Cream (Topoxy®) in the Treatment of Scalp Psoriasis
NCT02749656 ·Status: UNKNOWN ·Phase: PHASE3
-
PK and PD Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
NCT01766440 ·Status: COMPLETED ·Phase: PHASE4
-
Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of CD 2027 Spray in Adults With Plaque-type Psoriasis
NCT00763503 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study to Assess the Potential for Adrenal Suppression Following Maximal Use Treatment With DSXS
NCT02933528 ·Status: COMPLETED ·Phase: PHASE2
-
Safety Study in Patients With Scalp Psoriasis Suppression Following Maximal Use Treatment With Topical Product
NCT02933502 ·Status: COMPLETED ·Phase: PHASE2
-
Assess the Potential for Adrenal Suppression and Systemic Drug Absorption Following Multiple Dosing With DFD-06
NCT03179605 ·Status: TERMINATED ·Phase: PHASE2
-
Adrenal Suppression and Absorption Study of Halobetasol Propionate Foam in Subjects 12-17 With Plaque Psoriasis
NCT03992261 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis
NCT00004468 ·Status: WITHDRAWN ·Phase: NA
-
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Plaque Psoriasis
NCT02601469 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetics of 122-0551 and Its Effects on Adrenal Suppression
NCT01698333 ·Status: COMPLETED ·Phase: PHASE2
-
A Clinical Study to Evaluate the Safety and Pharmacokinetics of Topical RSS0393 Ointment in Children and Adolescents With Plaque Psoriasis
NCT07102888 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Plaque Psoriasis Study in Pediatric Subjects
NCT02186665 ·Status: COMPLETED ·Phase: PHASE4
-
Combining Topical Corticosteroid and LCD Treatment for Localized Plaque Psoriasis
NCT00769184 ·Status: COMPLETED ·Phase: NA
-
DFD01 Spray vs Comp01 Lotion HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis
NCT02070965 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Pharmacokinetics (PK) of Alefacept in Adolescent Subjects With Moderate to Severe Psoriasis
NCT00808223 ·Status: COMPLETED ·Phase: PHASE2
-
Iontophoresis in Psoriasis
NCT03979664 ·Status: WITHDRAWN ·Phase: EARLY_PHASE1
-
Efficacy and Safety Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis
NCT03701763 ·Status: COMPLETED ·Phase: PHASE3
-
Assessment for Tachyphylaxis to Topical Corticosteroids in the Treatment of Psoriasis
NCT01404338 ·Status: COMPLETED ·Phase: PHASE1
-
Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
NCT02125279 ·Status: COMPLETED ·Phase: PHASE4
-
Phase III Clinical Study in Patients With Mild to Severe Scalp Psoriasis
NCT02933866 ·Status: COMPLETED ·Phase: PHASE3
-
Trial to Assess the Potency of SOR007 Ointment in a Psoriasis Plaque Test
NCT03004339 ·Status: COMPLETED ·Phase: PHASE1
-
Desoximetasone Spray 0.05%, 0.25%; Dose Ranging Study
NCT01018134 ·Status: COMPLETED ·Phase: PHASE2