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

Last updated on October 10, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Stasis Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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

NCT04091087
Pfizer
Not yet recruiting
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis

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Descriptive Information
Brief Title  ICMJE Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
Official Title  ICMJE 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
Brief SummaryThis 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.
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.

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: Treatment
Condition  ICMJE Stasis Dermatitis
Intervention  ICMJE
  • Drug: crisaborole ointment
    crisaborole ointment
    Other Name: Eucrisa
  • Other: vehicle ointment
    vehicle ointment
Study Arms  ICMJE
  • Experimental: crisaborole ointment
    crisaborole ointment
    Intervention: Drug: crisaborole ointment
  • Sham Comparator: vehicle ointment
    vehicle ointment
    Intervention: Other: vehicle ointment
Publications *Not Provided


*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: September 13, 2019)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 7, 2020
Estimated Primary Completion DateOctober 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04091087
Other Study ID Numbers  ICMJE C3291038
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
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/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateSeptember 2019

ICMJE     Data element required by the

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

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

1-800-718-1021

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Contact

[email protected]

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