A Phase 2 interventional study of 146-9251 cream and Vehicle cream in Ichthyosis Vulgaris, sponsored by Crown Laboratories, Inc.. Completed at 7 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2021-08-10.
Sponsored by Crown Laboratories, Inc. · Phase 2, Interventional, and Treatment
The objective of this study is to determine and compare the safety and efficacy of topical 146-9251 cream and vehicle cream applied twice daily for 6 weeks in subjects with moderate to severe ichthyosis vulgaris (IV).
Exclusion Criteria:
Subject is pregnant, lactating, or is planning to become pregnant during the study.
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Drug: 146-9251 cream
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Drug: Vehicle cream
146-9251 cream contains an active drug and is applied topically.
Vehicle cream does not contain an active drug and is applied topically.
Treatment Success
Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
Time frame: Day 43 (6 weeks)
Adverse Events (AEs)
AEs will be assessed by the investigator and the number of participants with any local and systemic AEs will be reported.
Time frame: Day 0 through study completion, average 6 weeks, Day 43.
| Milestone | 146-9251 Cream | Vehicle Cream |
|---|---|---|
| Started | 40 | 40 |
| Completed | 36 | 38 |
| Not completed | 4 | 2 |
| Withdrew: Adverse event | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 2 |
Number of participants that show at least a 2 level improvement of overall severity of disease (as measured by IGA score) at 6 weeks. The IGA score is a static evaluation of the overall or "average" degree of severity of a participant's disease, taking into account all of the participant's scaling, erythema, and fissuring in the Treatment Area. IGA was assessed using the following 5-point scale: clear (0), almost clear (1), mild (2), moderate (3), or severe (4).
| Participants | 146-9251 Cream | Vehicle Cream |
|---|---|---|
| Treatment Success | 21 | 28 |
AEs will be assessed by the investigator and the number of participants with any local and systemic AEs will be reported.
| Participants | 146-9251 Cream | Vehicle Cream |
|---|---|---|
| Number of Subjects with any AE | 9 | 14 |
| Number of Subjects without an AE | 31 | 26 |
Collected over AEs were collected from study day 1 to end of study (week 6).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 146-9251 Cream | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Vehicle Cream | 0/40 (0%) | 0/40 (0%) | 5/40 (12.5%) |
| Event | 146-9251 Cream | Vehicle Cream |
|---|---|---|
| NasopharyngitisInfections and infestations | 0/40 | 5/40 |
Intent to treat (ITT) population defined as subjects who applied at least one dose of the assigned test article.
| Age, Continuous(years) | 146-9251 Cream | Vehicle Cream | Total |
|---|---|---|---|
| Mean | 54.8 ± 19.41 | 51.4 ± 17.42 | 53.1 ± 18.41 |
| Sex: Female, Male(Participants) | 146-9251 Cream | Vehicle Cream | Total |
|---|---|---|---|
| Female | 19 | 12 | 31 |
| Male | 21 | 28 | 49 |
| Ethnicity (NIH/OMB)(Participants) | 146-9251 Cream | Vehicle Cream | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 6 |
| Not Hispanic or Latino | 37 | 37 | 74 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | 146-9251 Cream | Vehicle Cream | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 4 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 5 | 7 |
| White | 33 | 30 | 63 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Investigator's Global Assessment (IGA) Score(Participants) | 146-9251 Cream | Vehicle Cream | Total |
|---|---|---|---|
| 3-Moderate | 30 | 31 | 61 |
| 4-Severe | 10 | 9 | 19 |
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Crown Laboratories, Inc.