A Phase 2 interventional study of crisaborole ointment and vehicle ointment in Stasis Dermatitis, sponsored by Pfizer. Completed at 4 sites in United States. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2022-05-02.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
crisaborole ointment
Drug: crisaborole ointment
vehicle ointment
Other: vehicle ointment
crisaborole ointment
Also known as: Eucrisa
vehicle ointment
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.
Time frame: Baseline, Week 6
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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)
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.
Time frame: Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks)
| Milestone | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Started | 33 | 33 |
| Treated | 32 | 33 |
| Completed | 23 | 26 |
| Not completed | 10 | 7 |
| Withdrew: Not treated | 1 | 0 |
| Withdrew: Adverse event | 4 | 4 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 5 | 2 |
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.
| Percent change | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | -18.07 ± 5.47 | -32.44 ± 5.09 |
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.
| Percentage of participants | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | 0 | 3.33 |
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.
| Percentage of participants | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Week 1 | 3.13 | 12.12 |
| Week 2 | 15.63 | 15.15 |
| Week 3 | 12.50 | 12.12 |
| Week 4 | 12.50 | 12.12 |
| Week 5 | 6.25 | 15.15 |
| Week 6 | 0 | 18.18 |
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.
| Percentage of participants | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| 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 |
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.
| Percentage of participants | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Week 1 | 43.75 | 51.52 |
| Week 2 | 37.50 | 54.55 |
| Week 3 | 43.75 | 45.45 |
| Week 4 | 43.75 | 45.45 |
| Week 5 | 25.00 | 45.45 |
| Week 6 | 21.88 | 51.52 |
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.
| Percent change | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Week 1 | -20.35 ± 9.55 | -16.48 ± 9.52 |
| Week 2 | -35.94 ± 8.14 | -40.41 ± 8.26 |
| Week 3 | -34.86 ± 10.26 | -25.05 ± 9.85 |
| Week 4 | -39.38 ± 11.14 | -4.64 ± 11.12 |
| Week 5 | -27.23 ± 10.41 | -28.89 ± 10.18 |
| Week 6 | -10.29 ± 8.60 | -52.48 ± 8.35 |
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.
| Percent change | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | -10.72 ± 7.06 | -3.80 ± 6.57 |
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.
| Percent change | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Week 1 | 10.28 ± 14.73 | -19.67 ± 14.98 |
| Week 2 | -13.21 ± 13.07 | -27.59 ± 13.50 |
| Week 3 | -31.58 ± 10.85 | -41.52 ± 10.44 |
| Week 4 | -2.34 ± 15.80 | -18.35 ± 15.93 |
| Week 5 | -6.05 ± 13.87 | -19.06 ± 13.91 |
| Week 6 | 18.67 ± 21.26 | -34.34 ± 21.23 |
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.
| Participants | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| TEAEs | 14 | 13 |
| SAEs | 4 | 1 |
Collected over Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle Ointment | 0/32 (0%) | 4/32 (12.5%) | 13/32 (40.6%) |
| Crisaborole 2% Ointment | 0/33 (0%) | 1/33 (3%) | 13/33 (39.4%) |
| Event | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| Muscular dystrophyCongenital, familial and genetic disorders | 1/32 | 0/33 |
| CellulitisInfections and infestations | 1/32 | 1/33 |
| CystitisInfections and infestations | 1/32 | 0/33 |
| Oropharyngeal squamous cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/32 | 0/33 |
| Event | Vehicle Ointment | Crisaborole 2% Ointment |
|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 1/32 | 3/33 |
| ErythemaSkin and subcutaneous tissue disorders | 2/32 | 2/33 |
| Urinary tract infectionInfections and infestations | 1/32 | 2/33 |
| HeadacheNervous system disorders | 1/32 | 2/33 |
| Dermatitis contactSkin and subcutaneous tissue disorders | 1/32 | 2/33 |
| Muscular dystrophyCongenital, familial and genetic disorders | 1/32 | 0/33 |
| DiarrhoeaGastrointestinal disorders | 1/32 | 0/33 |
| Oedema peripheralGeneral disorders | 1/32 | 0/33 |
| PyrexiaGeneral disorders | 1/32 | 1/33 |
| BronchitisInfections and infestations | 1/32 | 0/33 |
Full analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention. Participants were analyzed according to the intervention they were randomized.
| Age, Continuous(Years) | Vehicle Ointment | Crisaborole 2% Ointment | Total |
|---|---|---|---|
| Mean | 68.9 ± 9.81 | 66.0 ± 8.64 | 67.4 ± 9.28 |
| Sex: Female, Male(Participants) | Vehicle Ointment | Crisaborole 2% Ointment | Total |
|---|---|---|---|
| Female | 14 | 16 | 30 |
| Male | 18 | 17 | 35 |
| Ethnicity (NIH/OMB)(Participants) | Vehicle Ointment | Crisaborole 2% Ointment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 31 | 30 | 61 |
| Unknown or Not Reported | 1 | 1 | 2 |
| Race (NIH/OMB)(Participants) | Vehicle Ointment | Crisaborole 2% Ointment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 2 |
| White | 31 | 29 | 60 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 3 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: 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.
Data sharing details ↗ · www.pfizer.com
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Studies of the drug tested here: Crisaborole