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A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Burke Pharmaceutical Research
Hot Springs, Arkansas, 71913 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-23 months
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Aged ≥ 3 months at the screening visit to ≤ 24 months on baseline/Day 1, diagnosed with AD

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

Subjects with any clinically significant dermatological condition or disease (including
active or potentially recurrent non-AD dermatological conditions that overlap with AD such
as Netherton Syndrome)

NCT03356977
Pfizer
Recruiting
A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis

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Similar Trials

A Study of Crisaborole Ointment 2% in Children Aged 3-24 Months With Mild to Moderate Atopic Dermatitis
A Phase 4, Multicenter, Open-label Safety Study Of Crisaborole Ointment 2% In Children Aged 3 Months To Less Than 24 Months With Mild To Moderate Atopic Dermatitis
This 4-week study will evaluate the safety, pharmacokinetics (PK), and efficacy of crisaborole ointment 2%, applied twice daily (BID) in subjects who are 3 months to less than 24 months of age with mild-to-moderate AD.

Approximately 125 subjects will be enrolled. Subjects must have mild-to-moderate AD involving at least 5% treatable %BSA assessed on Baseline/Day 1. Treatable %BSA will be defined as the percent of a subject's total body surface area that is AD-involved, excluding the scalp.

In addition, a cohort of at least 16 of the 125 subjects will be included in a subgroup for PK assessment. These subjects must have moderate AD and a minimum of 35% treatable %BSA, excluding the scalp, and must complete all PK assessments to be included in the PK analysis. Of these subjects, approximately 3 subjects who are less than 9 months of age will be enrolled. Subjects discontinuing for reasons other than treatment emergent adverse event ( TEAE) may be replaced at the discretion of the sponsor to ensure 16 subjects complete the PK assessments. Only selected study sites will participate in the PK assessment.

Scheduled study visits/telephone contacts for all subjects will occur at Screening (up to 28 days prior to Baseline/Day 1), Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (end of treatment/early termination), Day 36, and Day 57 (end of study).

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Atopic Dermatitis
Drug: Crisaborole ointment 2%
Applied BID
Other Name: Eucrisa
Experimental: Crisaborole ointment 2%
Subjects will be dosed for 28 days. A thin layer of ointment will be applied to all areas designated for treatment.
Intervention: Drug: Crisaborole ointment 2%
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
125
December 1, 2018
December 1, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Aged ? 3 months at the screening visit to ? 24 months on baseline/Day 1, diagnosed with AD

Exclusion Criteria:

Subjects with any clinically significant dermatological condition or disease (including active or potentially recurrent non-AD dermatological conditions that overlap with AD such as Netherton Syndrome)

Sexes Eligible for Study: All
3 Months to 23 Months   (Child)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03356977
C3291002
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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