Study to Determine the Pharmacokinetics of Product 0405

An Open-Label, Multi-Center Study to Determine the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02176577

Enrollment

Registered

2014-06-27

Start date

2012-06-30

Completion date

2013-05-31

Last updated

2014-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

The purpose of this study is to evaluate the Pharmacokinetics of Product 0405 in the Treatment of Atopic Dermatitis in Adolescent Subjects.

Detailed description

Treament medication will be administered topically twice daily for 28 days.

Interventions

DRUGProduct 0405

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Months to 17 Years

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of Atopic Dermatitis * Good health with the exception of Atopic Dermatitis * Percent body surface area minimums

Exclusion criteria

* Subject who are nursing, pregnant or planning a pregnancy

Design outcomes

Primary

Measure	Time frame
Phamacokinetic sampling	28 days

Secondary

Measure	Time frame
Laboratory tests, vital signs, adverse events and local skin safety signs	28 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026