Trial · NCT04549792
An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses
NCT04549792, Early phase 1, Completed, Northwestern University; results first posted 2025-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses. Trials, record NCT04549792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04549792
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses
- NCT number
- NCT04549792
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 13 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Ichthyosis
- Interventions
- Ustekinumab
- First posted
- 2020-09-16
- Last updated
- 2025-02-12
- Results first posted
- 2025-02-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Reduction in Total Ichthyosis Severity Score | 7 months after initiation of study drug | To evaluate the efficacy of ustekinumab for ichthyosis, as measured by an at least 50% reduction in severity using the Ichthyosis Severity Score (ISS) measure. The ISS measures from 0-32, with 0 being the least clinically severe and 32 being the most clinically severe. |
| Primary | Occurence of Bacterial and Fungal Infections | 7 months after initiation of study drug | To evaluate the safety of ustekinumab for ichthyosis, based on occurrence of bacterial and fungal infections |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Reduction in Total Ichthyosis Severity Score | 7 months after initiation of study drug | units on a scale | MEAN | |
| PRIMARY | Occurence of Bacterial and Fungal Infections | 7 months after initiation of study drug | infections | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Reduction in Total Ichthyosis Severity Score | Open Label | -12.2 | Standard Deviation 29.9 | units on a scale | |
| Occurence of Bacterial and Fungal Infections | Open Label | Superficial skin infections | 3 | infections | |
| Occurence of Bacterial and Fungal Infections | Open Label | Streptococcal throat infection | 2 | infections | |
| Occurence of Bacterial and Fungal Infections | Open Label | Onychomycosis | 1 | infections |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label | 13 | |
| Overall Study | COMPLETED | Open Label | 13 | |
| Overall Study | NOT COMPLETED | Open Label | 0 |
Source ClinicalTrials.gov
Adverse events19
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 | Headache | General disorders | Open Label | 3 | 13 | 3 |
| other | Abdominal pain | Gastrointestinal disorders | Open Label | 1 | 13 | 1 |
| other | Amenorrhea | Reproductive system and breast disorders | Open Label | 1 | 13 | 1 |
| other | Broken wrist | Musculoskeletal and connective tissue disorders | Open Label | 1 | 13 | 1 |
| other | COVID-19 Infection | Infections and infestations | Open Label | 1 | 13 | 1 |
| other | Dry eyes | Eye disorders | Open Label | 1 | 13 | 1 |
| other | Pustular psoriasis like eruption | Skin and subcutaneous tissue disorders | Open Label | 1 | 13 | 1 |
| other | Heat exhaustion | General disorders | Open Label | 1 | 13 | 2 |
| other | Increased pain associated with ichthyosis | Skin and subcutaneous tissue disorders | Open Label | 1 | 13 | 1 |
| other | Miliaria | Skin and subcutaneous tissue disorders | Open Label | 1 | 13 | 1 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label | 0 | 13 |
| Total, other adverse events | Open Label | 10 | 13 |
| Total, serious adverse events | Open Label | 2 | 13 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04549792
GET https://conductscience.org/api/trials/v1/NCT04549792/registered