Trials Sponsors Conditions Drugs Pricing

Conditions

Stasis Dermatitis

Keywords

Stasis Dermatitisvenous hypertensionvenous 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 ointmentDrug

crisaborole ointment

Also known as: Eucrisa

crisaborole ointment

vehicle ointmentOther

vehicle ointment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age45 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Pfizer
Industrylead

Study Sites (4)

Lightship

El Segundo, California, 90245, United States

Hawthorne Effect, Inc

Lafayette, California, 94549, United States

Verily Life Sciences LLC

South San Francisco, California, 94080, United States

Onco360 Oncology Pharmacy

Louisville, Kentucky, 40223, United States

MeSH Terms

Conditions

Venous Insufficiency

Interventions

crisaborole

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

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

Study Officials

Pfizer CT.gov Call Center
Pfizer
STUDY DIRECTOR

Publication Agreements

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

Enrollment

66 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

crisaborole ointment

vehicle ointment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

crisaborole ointment

vehicle ointment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations