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CompletedNCT012325430405-01-04Updated Apr 11, 2012

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

A Phase 2 interventional study of Product 0405 in Atopic Dermatitis, sponsored by Fougera Pharmaceuticals Inc.. Completed at 1 site in United States. Open to participants aged 3 Months to 17 Years. Per ClinicalTrials.gov, last updated 2012-04-11.

Sponsored by Fougera Pharmaceuticals Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
114
Allocation
Not applicable
Ages
3 Months to 17 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 114 is above the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Fougera Pharmaceuticals Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Clinical diagnosis of Atopic Dermatitis
  • Good health with the exception of Atopic Dermatitis
  • Percent body surface area minimum requirements

Exclusion criteria

Exclusion Criteria:

  • Subjects who are pregnant, nursing, or planning a pregnancy
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
114 participants (actual)

Study arms

  • Experimental
    Product 0405

    Topical Active Investigational Product 0405

    Drug: Product 0405

Interventions

  • DrugProduct 0405

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

06

What researchers measure

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

07

Study locations

1 site
  • Fougera Pharmaceuticals Inc.
    Melville, New York 11747, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01232543
Lead sponsor
Fougera Pharmaceuticals Inc.
Responsible party
Sponsor
First posted
Nov 2, 2010
Start date
Nov 2010
Primary completion
Aug 2011
Completion
Nov 2011
Last update
Apr 11, 2012

Study contacts

Kathleen Ocasio, CCRA
study director · Fougera Pharmaceuticals Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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