Steroid-reducing Effects of Crisaborole

NCT03832010

Last updated date
Study Location
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Contact
443-287-8948

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

443-287-8948

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis, Eczema
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children aged 2 or older (<18).

- Diagnosed with atopic dermatitis.

- At baseline, AD is mild to moderate (score of 2 [mild] to 3 [moderate]) on the Investigator's Global Assessment scale (IGA; scores range 0-4, higher indicates greater severity).

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


- Known allergy to a constituent of the studied products (crisaborole, vehicle,
Aquaphor, topical steroids [hydrocortisone 2.5% ointment and triamcinolone acetonide
0.1% ointment]).


- At baseline, AD is severe (score of 4 [severe] on the IGA scale).


- Medical problems which interfere with completion of protocols in this study.


- Pregnant or lactating females. (Females who have experienced menarche will be required
to take a urine pregnancy test.)


- Participant is enrolled in another research study.


- Participant or participant's guardian(s) are unable to follow instructions as required
in this study.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Atopic Dermatitis, EczemaResponse of Children With Atopic Dermatitis (Eczema) to Eucrisa
NCT04023084
  1. Chicago, Illinois
ALL GENDERS
5 Years+
years
MULTIPLE SITES
Atopic Dermatitis, EczemaSteroid-reducing Effects of Crisaborole
NCT03832010
  1. Baltimore, Maryland
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Steroid-reducing Effects of Crisaborole
Official Title  ICMJE Proof of Concept Investigation of the Steroid-reducing Effects of Crisaborole in Children
Brief Summary Atopic dermatitis, or eczema, is a chronic skin condition affecting many children. Crisaborole is a non-steroid topical medication which is FDA approved for children aged 2 and older for eczema. This research study seeks to investigate whether crisaborole reduces topical steroid use in children with atopic dermatitis.
Detailed Description

Atopic dermatitis (AD) is a chronic skin disease and a common affliction among children. Twice daily topical corticosteroid (TCS) use over several weeks is recommended for active inflammatory disease. Side effects of TCS range from cutaneous atrophy to hypothalamic-pituitary-adrenal axis suppression. Steroid phobia and misunderstanding often lead to poor compliance and inadequate disease control. Topical calcineurin inhibitors (TCIs) are currently recommended as steroid-reducing agents, especially on sensitive areas such as the face and skin folds. However, TCis are associated with burning reactions and come with black box warnings.

Crisaborole (Eucrisa), the newest topical prescription option for AD, is a phosphodiesterase-4 inhibitor with demonstrated efficacy in patients aged 2 and older with mild to moderate AD. Given the good tolerability and favorable safety profile, crisaborole makes for an alternative topical option to its predecessors. However, corresponding data are lacking. It would be of great interest to patients, patients' families and providers if crisaborole can be shown to reduce the amount of TCS necessary for control of AD. The investigators therefore propose a proof-of-concept study to investigate whether crisaborole can serve as an effective steroid-reducing agent.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Atopic Dermatitis
  • Eczema
Intervention  ICMJE
  • Drug: Crisaborole
    Participants will be instructed to apply crisaborole to affected areas with eczema.
    Other Name: Eucrisa
  • Drug: Hydrocortisone Ointment
    Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
  • Drug: Triamcinolone ointment
    Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
  • Drug: Aquaphor
    Participants will be instructed to moisturize all over the body with Aquaphor.
Study Arms  ICMJE
  • Active Comparator: Crisaborole
    Participants will be instructed to apply emollient, topical steroid, and or crisaborole (blinded) to affected areas with eczema.
    Interventions:
    • Drug: Crisaborole
    • Drug: Hydrocortisone Ointment
    • Drug: Triamcinolone ointment
    • Drug: Aquaphor
  • Placebo Comparator: Vehicle
    Participants will be instructed to apply emollient, topical steroid, and or vehicle (blinded) to affected areas with eczema.
    Interventions:
    • Drug: Hydrocortisone Ointment
    • Drug: Triamcinolone ointment
    • Drug: Aquaphor
  • Sham Comparator: Control
    Participants will be instructed to apply emollient, topical steroid, and or emollient (blinded) to affected areas with eczema.
    Interventions:
    • Drug: Hydrocortisone Ointment
    • Drug: Triamcinolone ointment
    • Drug: Aquaphor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2020
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Children aged 2 or older (<18).
  • Diagnosed with atopic dermatitis.
  • At baseline, AD is mild to moderate (score of 2 [mild] to 3 [moderate]) on the Investigator's Global Assessment scale (IGA; scores range 0-4, higher indicates greater severity).

Exclusion criteria:

  • Known allergy to a constituent of the studied products (crisaborole, vehicle, Aquaphor, topical steroids [hydrocortisone 2.5% ointment and triamcinolone acetonide 0.1% ointment]).
  • At baseline, AD is severe (score of 4 [severe] on the IGA scale).
  • Medical problems which interfere with completion of protocols in this study.
  • Pregnant or lactating females. (Females who have experienced menarche will be required to take a urine pregnancy test.)
  • Participant is enrolled in another research study.
  • Participant or participant's guardian(s) are unable to follow instructions as required in this study.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Ji Qi, MD443-287-8948[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03832010
Other Study ID Numbers  ICMJE IRB00178631
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Bernard Cohen, MDJohns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP