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

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ClinicalTrials.gov Identifier: NCT04091087
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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 82 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)
Estimated Enrollment : 82 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
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : October 7, 2020
Estimated Study Completion Date : October 7, 2020

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 ]
    Proportion of participants with 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. Total sign score [ Time Frame: Weeks 1-5 ]
    Percent change from baseline in total sign score at all time points except Week 6

  3. Investigator's Static Global Assessment [ Time Frame: Weeks 1-6 ]
    Proportion of participants with a ISGA score of Clear (0) or Almost Clear (1) at all time points

  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

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

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 ClinicalTrials.gov identifier (NCT number): NCT04091087


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04091087     History of Changes
Other Study ID Numbers: C3291038
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
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: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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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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Dermatitis
Skin Diseases