Adrenal Suppression and Pharmacokinetics of Topicort® Spray, 0.25% in Pediatric Patients With Plaque Psoriasis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-23

Study Completion Date

2021-11-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Topical Scalp Psoriasis Study Evaluating Topicort Topical Spray

NCT02985736

Psoriasis

COMPLETED PHASE4

Desoximetasone Spray 0.25%, Hypothalamic Pituitary Adrenal (HPA) Axis Study

NCT01043393

Psoriasis

COMPLETED PHASE2

A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis

NCT03987763

Psoriasis

RECRUITING PHASE4

A Safety and Pharmacokinetics Study of IDP-118 Lotion in Pediatric Participants With Plaque Psoriasis

NCT03988439

Psoriasis

RECRUITING PHASE4

A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

NCT04080206

Plaque Psoriasis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An open label, post marketing safety study to assess the potential of a TOPICORT® (desoximetasone) Topical Spray, 0.25% to suppress HPA axis function following twice daily dosing for 28 days.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Plaque Psoriasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Topicort® Topical Spray, 0.25%

Topicort® (desoximetasone) Topical Spray, 0.25%, twice a day for 28 days

Group Type EXPERIMENTAL

Topicort® (desoximetasone) Topical Spray, 0.25%

Intervention Type DRUG

Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topicort® (desoximetasone) Topical Spray, 0.25%

Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

desoximetasone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients aged 7 years and older must have provided written assent accompanied by written informed consent from patient's representative
* Clinical diagnosis of stable plaque psoriasis with involvement of ≥ 10% body surface area (excluding face and scalp)
* Physicians Global Assessment score of 3 or 4 at baseline

Exclusion Criteria

* Has other dermatological conditions that may interfere with clinical assessments
* Allergy or sensitivity to corticosteroids or any drug hypersensitivity or intolerance that would compromise patient safety or study results
* History of an adverse reaction to Cortrosyn™ or similar test reagents
* Chronic infectious disease, system or organ disorder or other medical condition that would place patient at undue risk by study participation

Minimum Eligible Age

2 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No