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Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

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NCT03233529

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Innovaderm Research Incorporated
Montreal, Quebec, H2K 4L5 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
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.

NCT03233529
Pfizer
Recruiting
Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis

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Crisaborole Ointment 2% Skin Biomarker Biopsy Study in Atopic Dermatitis
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Dermatitis, Atopic
  • 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)
  • Experimental: Crisaborole ointment
    Intervention: Drug: Crisaborole ointment 2% BID
  • Placebo Comparator: Placebo ointment (vehicle)
    Intervention: Drug: Placebo ointment (vehicle)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
May 12, 2018
May 12, 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Canada
 
 
NCT03233529
C3291001
No
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
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
December 2017

ICMJE     Data element required by the

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

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