Safety Study Evaluating the Adrenal Suppression Potential of Product 0405 in Pediatric Subjects With Atopic Dermatitis (0405-01-04)

Fougera Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Product 0405

Study type: Interventional

Funder types: Industry

Identifiers

NCT01232543

0405-01-04

Details and patient eligibility

About

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

Full description

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

Enrollment: 114 patients

Sex: All

Ages: 3 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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114 participants in 1 patient group

Product 0405

Experimental group

Description:

Topical Active Investigational Product 0405

Treatment:

Drug: Product 0405