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

NCT04091087 | Completed Phase 2 Results FDA Drug

• 1 other identifier: C3291038
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

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.

Conditions

Stasis Dermatitis

Keywords

Stasis Dermatitis; venous hypertension; venous insufficiency

Outcome Measures

Primary Outcomes (1)

• Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment

  TSS assesses severity of stasis dermatitis lesions. There were following 4 clinical signs of all treatable stasis dermatitis lesions: erythema, papulation/elevation, superficial erosion/denudation, and scaling. Each of 4 signs were rated on a scale of 0 to 3 (0= none, 1= mild, 2= moderate, 3= severe). TSS = sum of scores from all clinical signs; ranging from 0 (none) to 12 (most severe), where higher score indicated greater severity. The assessment was completed in person by the home visit practitioner.

  Baseline, Week 6

Secondary Outcomes (8)

• Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment

  Week 6

• Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment

  Week 1, 2, 3, 4, 5 and 6

• Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 6: In-person Assessment

  Week 6

• Percentage of Participants With an Investigator's Static Global Assessment (ISGA) Score of Clear (0) or Almost Clear (1) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment

  Week 1, 2, 3, 4, 5 and 6

• Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment

  Baseline, Week 1, 2, 3, 4, 5 and 6

Study Arms (2)

crisaborole ointment

EXPERIMENTAL

crisaborole ointment

Drug: crisaborole ointment

vehicle ointment

SHAM COMPARATOR

vehicle ointment

Other: vehicle ointment

Interventions

crisaborole ointment DRUG

crisaborole ointment

Also known as: Eucrisa

crisaborole ointment

vehicle ointment OTHER

vehicle ointment

vehicle ointment

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (4)

Lightship

El Segundo, California, 90245, United States

Location

Hawthorne Effect, Inc

Lafayette, California, 94549, United States

Location

Verily Life Sciences LLC

South San Francisco, California, 94080, United States

Location

Onco360 Oncology Pharmacy

Louisville, Kentucky, 40223, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Venous Insufficiency

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 16, 2019
• Study Start: June 26, 2020
• Primary Completion: October 19, 2021
• Study Completion: October 19, 2021
• Last Updated: May 2, 2022
• Results First Posted: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)