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Completed

NCT Number: NCT01232543

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

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

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 month–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fougera Pharmaceuticals Inc.

Melville, New York, 11747, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Product 0405

Drug

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

Primary outcomes

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

    Time frame: 4 weeks

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Fougera Pharmaceuticals Inc.

Industry

Registry information

Official study title

An Open-Label Evaluation of the Adrenal Suppression Potential of Product 0405 in the Treatment of Moderate to Severe Atopic Dermatitis in Pediatric Subjects

Acronym: 0405-01-04

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 2, 2010
Registry last updated
Apr 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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