Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis

Fougera Pharmaceuticals Inc.114 enrolled

Overview

The aim of the trial is to assess Adrenal Suppression potential when pediatric subjects are administered Product 0405 for the treatment of Atopic Dermatitis

Treatment medication will be administered topically, twice a day for 4 weeks.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

114

Conditions

Atopic Dermatitis

Interventions

Product 0405DRUG

Product 0405 will be administered topically, twice daily for 28 days.

Eligibility

Sex: ALLMin age: 3 MonthsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Clinical diagnosis of Atopic Dermatitis * Good health with the exception of Atopic Dermatitis * Percent body surface area minimum requirements Exclusion Criteria: * Subjects who are pregnant, nursing, or planning a pregnancy

Locations (1)

Fougera Pharmaceuticals Inc.

Melville, New York, United States

Outcomes

Primary Outcomes

Hypothalamic Pituitary Adrenal (HPA) Axis Response to Cosyntropin demonstrating the absence or presence of adrenal suppression.

Time frame: 4 weeks

Secondary Outcomes

Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.

Time frame: 4 weeks

Data from ClinicalTrials.gov

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