Phase 2
N=66
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
Stasis Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT04091087 ↗Enrolled (actual)
66
Serious AEs
7.7%
Results posted
May 2022
Primary outcome: Primary: Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment — -18.07; -32.44 Percent change — p=0.0299
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- crisaborole ointment (Drug); vehicle ointment (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment |
-18.07; -32.44 | 0.0299 sig |
| SECONDARY Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment |
0; 3.33 | 0.1546 |
| SECONDARY 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 |
3.13; 12.12; 15.63; 15.15; 12.50; 12.12 | 0.0819 |
| SECONDARY 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 |
11.54; 16.67 | 0.2896 |
| SECONDARY 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 |
43.75; 51.52; 37.50; 54.55; 43.75; 45.45 | 0.2648 |
| SECONDARY Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment |
-20.35; -16.48; -35.94; -40.41; -34.86; -25.05 | 0.3874 |
| SECONDARY Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment |
-10.72; -3.80 | 0.2383 |
| SECONDARY Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment |
10.28; -19.67; -13.21; -27.59; -31.58; -41.52 | 0.0797 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
14; 13; 4; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT04091087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.