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A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

Last updated on June 21, 2018

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Study Location
Dermatology Trial Associates
Bryant, Arkansas, 72022 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
2+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

Is male or female 2 years and older at the Screening visit/time of informed consent/assent
diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at
least 5% BSA.

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

Has any clinically significant medical disorder, condition, or disease (including active or
potentially recurrent non AD dermatological conditions and known genetic dermatological
conditions that overlap with AD, such as Netherton syndrome.

Subjects in Cohort 1 are excluded if they have a contraindication for treatment with
hydrocortisone butyrate cream 0.1%

Subjects in Cohort 2 are excluded if they have a contraindication for treatment with
pimecrolimus cream, 1%

NCT03539601
Pfizer
Recruiting
A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD

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A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ? 2 Years, With Mild-moderate AD
A Phase 3b/4, Multicenter, Randomized, Assessor Blinded, Vehicle And Active (Topical Corticosteroid And Calcineurin Inhibitor) Controlled, Parallel Group Study Of The Efficacy, Safety, And Local Tolerability Of Crisaborole Ointment, 2% In Pediatric And Adult Subjects (Ages 2 Years And Older) With Mild To Moderate Atopic Dermatitis
This 4-week study will evaluate the safety and efficacy of crisaborole ointment 2%; crisaborole vehicle; topical corticosteroid and topical calcineurin inhibitor, applied twice daily (BID) in subjects who are at least 2 years of age with mild-moderate AD.

Approximately 600 subjects will be enrolled in the study, of which at least 150 subjects aged 2-6; at least 140 subjects aged 7-11; at least 120 subjects aged 12-17 and up to 90 subjects will be adults. Subjects must have mild-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.

Eligible subjects will be randomized at the Baseline/Day 1 visit. Randomization will be stratified by eligibility for TCS or TCI treatment as per national approved labels. Cohort 1 will be for subjects who are eligible for TCS therapy, and Cohort 2 will be for subjects who are not eligible for TCS therapy but eligible for TCI therapy. The investigational products will be applied BID for 28 days to the Treatable body surface area (BSA) identified at Baseline/Day 1.

The primary efficacy endpoint is the percent change from baseline in the Eczema Area and Severity Index (EASI) total score at Day 29.

For the efficacy comparison of crisaborole versus vehicle, subjects from both Cohort 1 and Cohort 2 are included in the analysis, adjusted for cohort effect. For the efficacy comparison of crisaborole versus TCS, only subjects from Cohort 1 are included in the analysis. For the comparison of crisaborole versus TCI, only subjects from Cohort 2 are included in the analysis.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Scheduled study visits for all subjects will occur at Screening, Baseline/Day 1, Day 8, Day 15, Day 22, Day 29 (End of treatment/Early termination). A follow up telephone call will be made by site staff to the subjects/subject's legally acceptable guardian(s) on Day 36 and Day 60.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

The investigational products above are masked for appearance, and will be placed into identical cartons. Once removed from the product cartons, the investigational products could be discerned from each other based on commercial product tube shape/size and should only be handled by unblinded site personnel.

Safety and efficacy assessments will be conducted at the investigator site by a clinical assessor blinded to treatment assignment.

Primary Purpose: Treatment

Atopic Dermatitis
  • Drug: Crisaborole ointment, 2%
    Applied twice a day (BID)
    Other Name: Eucrisa
  • Drug: Hydrocortisone butyrate cream, 0.1%
    Applied BID
    Other Name: Locoid 0.1%
  • Drug: Pimecrolimus cream, 1%
    Applied BID
    Other Name: Elidel
  • Drug: Crisaborole Vehicle
    Applied BID
  • Experimental: Crisaborole ointment, 2%
    This treatment arm will be administered both in Cohort 1 and Cohort 2.
    Intervention: Drug: Crisaborole ointment, 2%
  • Active Comparator: Hydrocortisone butyrate cream, 0.1%
    This treatment arm will be administered in Cohort 1 only.
    Intervention: Drug: Hydrocortisone butyrate cream, 0.1%
  • Active Comparator: Pimecrolimus cream, 1%
    This treatment arm will be administered in Cohort 2 only.
    Intervention: Drug: Pimecrolimus cream, 1%
  • Placebo Comparator: Crisaborole Vehicle
    This treatment arm will be administered both in Cohort 1 and Cohort 2.
    Intervention: Drug: Crisaborole Vehicle
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
Same as current
May 25, 2020
May 25, 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Is male or female 2 years and older at the Screening visit/time of informed consent/assent diagnosed with mild-moderate AD (according to the criteria of Hanifin and Rajka), of at least 5% BSA.

Exclusion Criteria:

Has any clinically significant medical disorder, condition, or disease (including active or potentially recurrent non AD dermatological conditions and known genetic dermatological conditions that overlap with AD, such as Netherton syndrome.

Subjects in Cohort 1 are excluded if they have a contraindication for treatment with hydrocortisone butyrate cream 0.1%

Subjects in Cohort 2 are excluded if they have a contraindication for treatment with pimecrolimus cream, 1%

Sexes Eligible for Study: All
2 Years and older   (Child, Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
United States
 
 
NCT03539601
C3291037
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
May 2018

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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