Study Comparing Product 0405 to a Vehicle Control in the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Subjects

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Product 0405 To A Vehicle Control In The Treatment Of Mild To Moderate Atopic Dermatitis In Pediatric Subjects

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02176538

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 safety and efficacy of product 0405 in pediatric subjects with Mild to Moderate Atopic Dermatitis.

Detailed description

Treatment medication will be administered topically twice daily for 28 days

Interventions

DRUGProduct 0405

Product 0405 will be administered topically twice daily for 28 days

DRUGPlacebo for Product 0405

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

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 minimum requirements

Exclusion criteria

* Subjects who are pregnant, nursing or planning a pregnancy

Design outcomes

Primary

Measure	Time frame
Statistically significant superiority of the test Product 0405 to the vehicle	28 days

Secondary

Measure	Time frame
Incidence of success based on the Investigators Static Global Assessment and the Clinical Signs and Symptoms (erythema, scaling) at the end of treatment.	28 days

Outcome results

None listed

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