Trial · NCT04091087
Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
NCT04091087, Phase 2, Completed, Pfizer; results first posted 2022-05-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis. Trials, record NCT04091087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04091087
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Efficacy and Safety of Crisaborole in Adults With Stasis Dermatitis
- NCT number
- NCT04091087
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 66 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Stasis Dermatitis
- Interventions
- crisaborole ointment, vehicle ointment
- First posted
- 2019-09-16
- Last updated
- 2022-05-02
- Results first posted
- 2022-05-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | 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. |
| Secondary | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | Week 6 | 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. |
| 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 | Week 1, 2, 3, 4, 5 and 6 | 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. |
| 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 | Week 6 | 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. |
| 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 | Week 1, 2, 3, 4, 5 and 6 | 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. |
| Secondary | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Baseline, Week 1, 2, 3, 4, 5 and 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. Participants acquired static digital images of the lesions using sponsor-provisioned digital imaging equipment. Images were reviewed by central readers. |
| Secondary | Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | Baseline, Week 6 | 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. |
| 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 | Baseline, Week 1, 2, 3, 4, 5 and 6 | 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. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks) | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | Baseline, Week 6 | 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. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | Week 6 | 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. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure | Percentage of participants | NUMBER |
| 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 | Week 1, 2, 3, 4, 5 and 6 | 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. | Percentage of participants | NUMBER |
| 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 | Week 6 | 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. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| 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 | Week 1, 2, 3, 4, 5 and 6 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Total Sign Score (TSS) at Week 1, 2, 3, 4, 5 and 6: Central Readers Digital Images Assessment | Baseline, Week 1, 2, 3, 4, 5 and 6 | 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. Here, number analyzed signifies participants evaluable for the specified rows. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percent Change From Baseline in Stasis Dermatitis Lesional Percent Body Surface Area (BSA) at Week 6: In-person Assessment | Baseline, Week 6 | 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. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure. | Percent change | LEAST_SQUARES_MEAN |
| 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 | Baseline, Week 1, 2, 3, 4, 5 and 6 | 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. Here, number analyzed signifies participants evaluable for the specified rows. | Percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Day 1 up to maximum of 4 weeks after the last dose (maximum for 10 weeks) | Safety analysis set included all participants who were randomly assigned to study intervention and applied at least 1 dose of study intervention and were analyzed according to intervention actually received. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | Vehicle Ointment | -18.07 | Standard Error 5.47 | Percent change | |
| Percent Change From Baseline in Total Sign Score (TSS) at Week 6: In-person Assessment | Crisaborole 2% Ointment | -32.44 | Standard Error 5.09 | Percent change | |
| Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | Vehicle Ointment | 0 | Percentage of participants | ||
| Percentage of Participants Who Achieved Treatment Success Based on Investigator's Static Global Assessment (ISGA) at Week 6: In-person Assessment | Crisaborole 2% Ointment | 3.33 | Percentage of participants | ||
| 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 | Vehicle Ointment | Week 1 | 3.13 | Percentage of participants | |
| 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 | Crisaborole 2% Ointment | Week 1 | 12.12 | Percentage of participants | |
| 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 | Vehicle Ointment | Week 2 | 15.63 | Percentage of participants | |
| 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 | Crisaborole 2% Ointment | Week 2 | 15.15 | Percentage of participants | |
| 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 | Vehicle Ointment | Week 3 | 12.50 | Percentage of participants | |
| 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 | Crisaborole 2% Ointment | Week 3 | 12.12 | Percentage of participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vehicle Ointment | 33 | |
| Overall Study | STARTED | Crisaborole 2% Ointment | 33 | |
| Overall Study | Treated | Vehicle Ointment | 32 | |
| Overall Study | Treated | Crisaborole 2% Ointment | 33 | |
| Overall Study | COMPLETED | Vehicle Ointment | 23 | |
| Overall Study | COMPLETED | Crisaborole 2% Ointment | 26 | |
| Overall Study | NOT COMPLETED | Vehicle Ointment | 10 | |
| Overall Study | NOT COMPLETED | Crisaborole 2% Ointment | 7 |
Source ClinicalTrials.gov
Adverse events80
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Muscular dystrophy | Congenital, familial and genetic disorders | Vehicle Ointment | 1 | 32 | |
| other | Muscular dystrophy | Congenital, familial and genetic disorders | Crisaborole 2% Ointment | 0 | 33 | |
| other | Diarrhoea | Gastrointestinal disorders | Vehicle Ointment | 1 | 32 | |
| other | Diarrhoea | Gastrointestinal disorders | Crisaborole 2% Ointment | 0 | 33 | |
| other | Food poisoning | Gastrointestinal disorders | Vehicle Ointment | 0 | 32 | |
| other | Food poisoning | Gastrointestinal disorders | Crisaborole 2% Ointment | 1 | 33 | |
| other | Nausea | Gastrointestinal disorders | Vehicle Ointment | 0 | 32 | |
| other | Nausea | Gastrointestinal disorders | Crisaborole 2% Ointment | 1 | 33 | |
| other | Oesophageal spasm | Gastrointestinal disorders | Vehicle Ointment | 0 | 32 | |
| other | Oesophageal spasm | Gastrointestinal disorders | Crisaborole 2% Ointment | 1 | 33 |
1 to 10 of 80Source ClinicalTrials.gov
See all 80 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle Ointment | 0 | 32 |
| Total, all-cause mortality | Crisaborole 2% Ointment | 0 | 33 |
| Total, other adverse events | Vehicle Ointment | 13 | 32 |
| Total, other adverse events | Crisaborole 2% Ointment | 13 | 33 |
| Total, serious adverse events | Vehicle Ointment | 4 | 32 |
| Total, serious adverse events | Crisaborole 2% Ointment | 1 | 33 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Crisaborole 2% Ointment vs Vehicle Ointment: deaths from any cause | Trial comparisons |
| Crisaborole 2% Ointment vs Vehicle Ointment: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04091087
GET https://conductscience.org/api/trials/v1/NCT04091087/results?page=2