Stasis DermatitisPhase 2NCT04091087
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
A Phase 2 study testing crisaborole ointment in people with Stasis Dermatitis, run by Pfizer at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Stasis Dermatitis
- What is being tested?
- crisaborole ointment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Jun 2020to 19 Oct 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Lightship
El Segundo, California, 90245
Hawthorne Effect, Inc
Lafayette, California, 94549
Onco360 Oncology Pharmacy
Louisville, Kentucky, 40223
Verily Life Sciences LLC
South San Francisco, California, 94080
About this study
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
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.
Read the 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.
- Conditions
- Stasis Dermatitis
- Being tested
- crisaborole ointment, vehicle ointment
- Keywords
- Stasis Dermatitis, venous hypertension, venous insufficiency
- Medical subject headings
- Venous Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
crisaborole ointmentDrug
Also called Eucrisa
crisaborole ointment
vehicle ointmentOther
vehicle ointment
| Study group | Role | What they receive |
|---|---|---|
| crisaborole ointment | Experimental | crisaborole ointment Receives: Drug: crisaborole ointment |
| vehicle ointment | Sham comparator | vehicle ointment Receives: Other: vehicle ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner. Treatment success was defined as ISGA score of clear/almost clear with at least a 2-grade improvement from baseline.
Measured: 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
ISGA: global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling, excluding scalp. ISGA score ranged from 0 to 4; 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores = greater severity. Treatment success: ISGA score of clear/almost clear with at least a 2-grade improvement from baseline. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Measured: 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
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. The assessment was completed in person by the home visit practitioner.
Measured: 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
ISGA is a global assessment of stasis dermatitis lesions severity based on erythema, papulation/elevation, superficial erosion/denudation, and scaling. ISGA excludes scalp from scoring and assessment. ISGA score ranged from 0 to 4; where 0 = clear (minor residual hypo/hyperpigmentation; no erythema or induration/papulation; no oozing/crusting), 1= almost clear (trace faint pink erythema, with barely perceptible induration/papulation and no oozing/crusting), 2= mild (faint pink erythema with mild induration/papulation and no oozing/crusting), 3= moderate (pink-red erythema with moderate induration/papulation with or without oozing/crusting), 4= severe (deep or bright red erythema with severe induration/papulation and with oozing/crusting). Higher scores indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Measured: 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
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. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Measured: Baseline, Week 1, 2, 3, 4, 5 and 6
Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment
Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. The assessment was completed in person by the home visit practitioner.
Measured: Baseline, Week 6
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Stasis dermatitis lesional BSA was calculated using handprint method. Number of handprints (size of participant's full palmer hand) fitting in affected area was counted. One handprint represented approximately 1% of lesional BSA. Percent BSA for a body region = total number of handprints in a body region * % surface area equivalent to 1 handprint. Higher % BSA indicated greater severity. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers.
Measured: Baseline, Week 1, 2, 3, 4, 5 and 6
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) was any untoward medical occurrence attributed to a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent were events between first dose of study drug and up to 4 weeks after last dose that were absent before treatment or that worsened relative to pre-treatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; Initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs included both SAEs and all non-SAEs.
Measured: Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start26 Jun 2020
- Primary completion19 Oct 2021
- Study completion19 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stasis DermatitisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091087
- Sponsor's protocol ID
- C3291038
- Status last verified
- Apr 2022
- First submitted
- 13 Sep 2019
- Last updated
- 2 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04091087
- Acronym / sponsor ID
- C3291038
- Conditions
- Stasis Dermatitis
- Keywords
- Stasis Dermatitis, venous hypertension, venous insufficiency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2020 (actual)
- Primary completion
- 19 Oct 2021 (actual)
- Study completion
- 19 Oct 2021 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Posted 2 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| crisaborole ointment | Experimental | Drug: crisaborole ointmentcrisaborole ointment |
| vehicle ointment | Sham comparator | Other: vehicle ointmentvehicle ointment |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| crisaborole ointmentAlso: Eucrisacrisaborole ointment | Drug | crisaborole ointment |
| vehicle ointmentvehicle ointment | Other | vehicle ointment |
Primary outcome
Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment
Time frame: Baseline, Week 6
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.
8 secondary outcomes
Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, Week 1, 2, 3, 4, 5 and 6
Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment
Time frame: Baseline, Week 6
Percent Change From Baseline in Percent Body Surface Area (BSA) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment
Time frame: Baseline, Week 1, 2, 3, 4, 5 and 6
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Stasis Dermatitis
Recruiting
Short and Ultra-short-pulse ND: YAG 1064nm Lasers (Omer Smart and Omer Premium) for Stasis Dermatitis
Stasis Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing crisaborole ointment in people with Stasis Dermatitis, run by Pfizer at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.