Ichthyosis Vulgaris
Conditions
Brief summary
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).
Interventions
DRUG146-9251 cream
146-9251 cream contains an active drug and is applied topically.
DRUGVehicle cream
Vehicle cream does not contain an active drug and is applied topically.
Sponsors
Crown Laboratories, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Placebo controlled
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is a male or female and is at least 12 years old at the time of enrollment. 2. Subject has provided written informed consent/assent. A subject under 18 years of age must provide written informed assent and be accompanied by the parent or legal guardian at the time of assent/consent signing. The parent or legal guardian must provide informed consent for the subject. If a subject becomes 18 years of age during the study, the subject must provide written informed consent at that time to continue study participation. 3. Subject and parent/guardian (if applicable) are willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study. 4. Subject has a clinical diagnosis of ichthyosis vulgaris involving a minimum of 5% body surface area (BSA). If the subject has IV involving over 40% BSA, the investigator must be able to identify a Treatment Area comprising distinct anatomic units that contains about 40% (excluding the scalp and mucosal areas) as detailed in Section 6.2. 5. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit. 6. Subject is in good general health and free of any disease state or physical condition that might impair evaluation of IV or which, in the investigator's opinion, exposes the subject to an unacceptable risk by study participation. 7. Females must be post-menopausal, surgically sterile, or use an effective method of birth control. , Women of childbearing potential (WOCBP) must have with a negative urine pregnancy test (UPT) at the Baseline Visit.
Exclusion criteria
* 1\. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2\. Subject is currently enrolled in an investigational drug or device study. 3. Subject has used an investigational drug or investigational device treatment within 30 days prior to first application of the test article. 4\. Subject has used any topical therapy, including topical corticosteroids or retinoids, in the Treatment Area within 2 weeks prior to the initiation of treatment. Note: a bland emollient may be used in the Treatment Area up to 3 days prior to the initiation of treatment. 5\. Subject has used systemic corticosteroids within 4 weeks or retinoids within 24 weeks prior to the initiation of treatment. 6\. Subject has stable use of vitamin or herbal supplements for less than 2 weeks prior to the initiation of treatment. 7\. Subject has a history of sensitivity to any of the ingredients in the test articles. 8\. Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator. 9\. Subject has a physical condition or other dermatologic disorders (e.g., atopic, seborrheic or contact dermatitis, psoriasis, tinea infections, etc.) which, in the investigator's opinion, might impair evaluation of IV, or which exposes the subject to unacceptable risk by study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Success | Day 43 (6 weeks) | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (AEs) | Day 0 through study completion, average 6 weeks, Day 43. | AEs will be assessed by the investigator and the number of participants with any local and systemic AEs will be reported. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 146-9251 Cream Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
146-9251 cream: 146-9251 cream contains an active drug and is applied topically. | 40 |
| Vehicle Cream Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Vehicle cream: Vehicle cream does not contain an active drug and is applied topically. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | 146-9251 Cream | Total | Vehicle Cream |
|---|---|---|---|
| Age, Continuous | 54.8 years STANDARD_DEVIATION 19.41 | 53.1 years STANDARD_DEVIATION 18.41 | 51.4 years STANDARD_DEVIATION 17.42 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 6 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 37 Participants | 74 Participants | 37 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Investigator's Global Assessment (IGA) Score 3-Moderate | 30 Participants | 61 Participants | 31 Participants |
| Investigator's Global Assessment (IGA) Score 4-Severe | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 33 Participants | 63 Participants | 30 Participants |
| Sex: Female, Male Female | 19 Participants | 31 Participants | 12 Participants |
| Sex: Female, Male Male | 21 Participants | 49 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 5 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
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)
Population: ITT population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 146-9251 Cream | Treatment Success | 21 Participants |
| Vehicle Cream | Treatment Success | 28 Participants |
Other Pre-specified
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.
Population: ITT population
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 146-9251 Cream | Adverse Events (AEs) | Number of Subjects with any AE | 9 Participants |
| 146-9251 Cream | Adverse Events (AEs) | Number of Subjects without an AE | 31 Participants |
| Vehicle Cream | Adverse Events (AEs) | Number of Subjects with any AE | 14 Participants |
| Vehicle Cream | Adverse Events (AEs) | Number of Subjects without an AE | 26 Participants |