Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

NCT03233529

Last updated date
Study Location
Innovaderm Research Incorporated
Montreal, Quebec, H2K 4L5, Canada
Contact
1-800-718-1021

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By email

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

- Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to Screening and that has been clinically stable for 1 month.

- Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at Baseline.

- Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles.

- Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical Lesion ISGA score of greater than/equal to 3.

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


- Clinically infected AD or requires high potency topical corticosteroids or systemic
(oral/injectable) corticosteroids to manage AD.


- History of angioedema or anaphylaxis to topical products or known sensitivity to
components of crisaborole ointment 2%.


- History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the
skin).


- Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the
reason of lack of efficacy.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
Official Title  ICMJE A PHASE 2A, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED STUDY, TO CHARACTERIZE THE MECHANISM OF ACTION OF CRISABOROLE OINTMENT 2%, BY EVALUATION OF EFFICACY AND CHANGES IN SKIN BIOMARKERS, IN ADULT SUBJECTS WITH MILD TO MODERATE ATOPIC DERMATITIS, WITH A 4 WEEK OPEN-LABEL EXTENSION
Brief Summary This study is being conducted to characterize the mechanism of action of crisaborole ointment 2%, by evaluation of efficacy and changes in key skin biomarkers in atopic dermatitis (AD) lesions treated with crisaborole ointment 2% over vehicle, in subjects with mild to moderate AD. Two identified AD skin lesions for each subject will be treated for the first 15 days, one with crisaborole ointment 2% and one with vehicle, in a blinded manner, and biopsies for biomarker analysis will be performed on the lesions. Following completion of the blinded treatment period, subjects will start the 28 day open label period during which all AD affected skin lesions will be treated with crisaborole ointment 2% twice daily.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: Crisaborole ointment 2% BID
    Crisaborole ointment 2% BID for 15 days (double blind); additional 28 days (open label)
  • Drug: Placebo ointment (vehicle)
    Placebo ointment (vehicle) BID for 15 days (double blind)
Study Arms  ICMJE
  • Experimental: Crisaborole ointment
    Intervention: Drug: Crisaborole ointment 2% BID
  • Placebo Comparator: Placebo ointment (vehicle)
    Intervention: Drug: Placebo ointment (vehicle)
Publications * Bissonnette R, Pavel AB, Diaz A, Werth JL, Zang C, Vranic I, Purohit VS, Zielinski MA, Vlahos B, Estrada YD, Saint-Cyr Proulx E, Ports WC, Guttman-Yassky E. Crisaborole and atopic dermatitis skin biomarkers: An intrapatient randomized trial. J Allergy Clin Immunol. 2019 Nov;144(5):1274-1289. doi: 10.1016/j.jaci.2019.06.047. Epub 2019 Aug 13.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 25, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 4, 2018
Actual Primary Completion Date May 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Confirmed diagnosis of active atopic dermatitis (AD) with at least 6 month history prior to Screening and that has been clinically stable for 1 month.
  • Investigator's Static Global Assessment (ISGA) of 2 (mild) or 3 (moderate) at Baseline.
  • Body surface area (BSA) covered with AD of at least 0.5% and no more than 10% at Baseline, calculation excluding face, scalp, axilla, genitals, groin area, palms, back of the hands, and soles.
  • Two lesions of AD at least 3 cm x 3 cm in size and at least 5 cm apart, with identical Lesion ISGA score of greater than/equal to 3.

Exclusion Criteria:

  • Clinically infected AD or requires high potency topical corticosteroids or systemic (oral/injectable) corticosteroids to manage AD.
  • History of angioedema or anaphylaxis to topical products or known sensitivity to components of crisaborole ointment 2%.
  • History of cancer (except squamous or basal cell carcinoma or carcinoma in situ of the skin).
  • Previous treatment with any topical or systemic PDE4 inhibitor unless stopped for the reason of lack of efficacy.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03233529
Other Study ID Numbers  ICMJE C3291001
Has Data Monitoring Committee No
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.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date July 2019

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