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Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04091087
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : November 9, 2021
Information provided by (Responsible Party):

Brief Summary:
This is a Phase 2a, randomized, double blind, vehicle controlled, parallel group, proof of concept study that will include participants with stasis dermatitis without active skin ulceration, who will receive crisaborole ointment 2% or vehicle twice daily for 6 weeks.

Condition or disease Intervention/treatment Phase
Stasis Dermatitis Drug: crisaborole ointment Other: vehicle ointment Phase 2

Detailed Description:

Study C3291038 is a Phase 2a, randomized, double-blind, vehicle-controlled, parallel-group, proof of concept study to evaluate the efficacy, safety, and local tolerability of 6 weeks of treatment with crisaborole in adult participants with SD without active skin ulceration. Approximately 70 eligible participants will be randomized into the double blind treatment period in a 1:1 ratio to receive crisaborole ointment, 2% or vehicle twice daily for 6 weeks.

The study will recruit male and female participants aged ≥ 45 years with a clinical diagnosis of SD.

The total duration of participation in the study will be up to 14 weeks, including up to 4 weeks for screening, a 6 week double blind treatment period, and a follow-up period of 4 weeks after treatment completion.

Study enrollment and management will be de centralized, where participants do not visit an investigator or a clinic for clinical assessment. The participants will participate in the study at home. The sponsor (or designee) will provide home visits by qualified home visit practitioners (HVP), remote contact by telemedicine (or telephone), and clinical database electronic case report forms (eCRFs), eDiary, and other electronic data entries from 3rd party vendors for study data collection.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Local Tolerability of Crisaborole Ointment, 2%, in Adult Participants With Stasis Dermatitis Without Active Skin Ulceration
Actual Study Start Date : June 26, 2020
Actual Primary Completion Date : October 19, 2021
Actual Study Completion Date : October 19, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Crisaborole

Arm Intervention/treatment
Experimental: crisaborole ointment
crisaborole ointment
Drug: crisaborole ointment
crisaborole ointment
Other Name: Eucrisa

Sham Comparator: vehicle ointment
vehicle ointment
Other: vehicle ointment
vehicle ointment

Primary Outcome Measures :
  1. Percent change from baseline in Total Sign Score [ Time Frame: 6 weeks ]
    Percent change from baseline in Total Sign Score at Week 6

Secondary Outcome Measures :
  1. Investigator's Static Global Assessment [ Time Frame: Weeks 1-6 ]
    Achievement of an Investigator's Static Global Assessment score of Clear (0) or Almost Clear (1) with at least a 2 grade improvement from baseline at all time points

  2. Investigators Static Global Assessment [ Time Frame: Weeks 1-6 ]
    Achievement of an Investigator's Static Global Assessment score of Clear (0) or Almost Clear (1) at all time points

  3. Total Sign Score [ Time Frame: Weeks 1-6 ]
    Percent change from baseline in TSS at all time points (Central Readers digital images assessment)

  4. Lesional percent body surface area [ Time Frame: Weeks 1-6 ]
    Percent change from baseline in lesional % Body Surface Area

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Participants who are ≥45 years of age and in generally stable health
  • Participants who are in generally stable health and have a known diagnosis of Stasis Dermatitis or newly diagnosed Stasis Dermatitis
  • Participants whose mental and physical status allows them to be able to mostly perform their activities of daily living with minimal assistance

Exclusion Criteria:

  • Participants with clinically significant active or potentially recurrent dermatitis conditions and known genetic dermatological conditions that are not Stasis Dermatitis or overlap with Stasis Dermatitis
  • Participants with active venous stasis ulceration on either lower extremity.
  • Participants with current infection or suspected infection of any Stasis Dermatitis lesions
  • Women of child bearing potential (WOCBP) are not eligible for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04091087

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United States, California
El Segundo, California, United States, 90245
Hawthorne Effect, Inc
Lafayette, California, United States, 94549
Verily Life Sciences LLC
South San Francisco, California, United States, 94080
United States, Kentucky
Onco360 Oncology Pharmacy
Louisville, Kentucky, United States, 40223
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer Identifier: NCT04091087    
Other Study ID Numbers: C3291038
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: November 9, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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:

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
Stasis Dermatitis
venous hypertension
venous insufficiency
Additional relevant MeSH terms:
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Skin Diseases