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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Stasis Dermatitis

Treatments: Drug: crisaborole ointment; Other: vehicle ointment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04091087

C3291038

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

66 participants in 2 patient groups

crisaborole ointment

Experimental group

Description:

crisaborole ointment

Treatment:

Drug: crisaborole ointment

vehicle ointment

Sham Comparator group

Description:

vehicle ointment

Treatment:

Other: vehicle ointment