Clinical trial NCT04091087: Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stasis Dermatitis
Keywords: Stasis Dermatitis
venous hypertension
venous insufficiency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 66
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment
timeFrame: Week 6
measure: 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
timeFrame: Week 1, 2, 3, 4, 5 and 6
measure: 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
timeFrame: Week 6
measure: 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
timeFrame: Week 1, 2, 3, 4, 5 and 6
measure: Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
timeFrame: Baseline, Week 1, 2, 3, 4, 5 and 6
measure: Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment
timeFrame: Baseline, Week 6
measure: Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
timeFrame: Baseline, Week 1, 2, 3, 4, 5 and 6
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Other outcomes:
Locations:
city: El Segundo
country: United States
facility: Lightship
state: California
city: Lafayette
country: United States
facility: Hawthorne Effect, Inc
state: California
city: South San Francisco
country: United States
facility: Verily Life Sciences LLC
state: California
city: Louisville
country: United States
facility: Onco360 Oncology Pharmacy
state: Kentucky
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: