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CompletedNCT03173547Updated Aug 10, 2021Results posted

A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris

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

Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Ichthyosis Vulgaris
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

    1. Subject is pregnant, lactating, or is planning to become pregnant during the study.

      1. 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.
      1. 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.
      1. Subject has used systemic corticosteroids within 4 weeks or retinoids within 24 weeks prior to the initiation of treatment.
      1. Subject has stable use of vitamin or herbal supplements for less than 2 weeks prior to the initiation of treatment.
      1. Subject has a history of sensitivity to any of the ingredients in the test articles.
      1. 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.
      1. 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.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
80 participants (actual)

Study arms

  • Active comparator
    146-9251 cream

    Topical cream to be applied two times daily to specified treatment areas for 6 weeks.

    Drug: 146-9251 cream

  • Placebo comparator
    Vehicle cream

    Topical cream to be applied two times daily to specified treatment areas for 6 weeks.

    Drug: Vehicle cream

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.

05

What researchers measure

Primary outcomes

  1. 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)

Other outcomes

  1. 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.

06

Results

Posted Jul 14, 2021

Participant flow

Participant flow — Overall Study
Milestone146-9251 CreamVehicle Cream
Started4040
Completed3638
Not completed42
Withdrew: Adverse event20
Withdrew: Withdrawal by subject22

Outcome measures

PrimaryTreatment 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)
Reported as:
Count of participants · Participants
Treatment Success
Participants146-9251 CreamVehicle Cream
Treatment Success2128
Other pre-specifiedAdverse 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.
Reported as:
Count of participants · Participants
Adverse Events (AEs)
Participants146-9251 CreamVehicle Cream
Number of Subjects with any AE914
Number of Subjects without an AE3126

Adverse events

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.

Adverse event summary by group
GroupDeathsSeriousOther
146-9251 Cream0/40 (0%)0/40 (0%)0/40 (0%)
Vehicle Cream0/40 (0%)0/40 (0%)5/40 (12.5%)
Most frequent other events
Most frequent other events
Event146-9251 CreamVehicle Cream
NasopharyngitisInfections and infestations0/405/40

Baseline characteristics

Intent to treat (ITT) population defined as subjects who applied at least one dose of the assigned test article.

Age, Continuous
Age, Continuous(years)146-9251 CreamVehicle CreamTotal
Mean54.8 ± 19.4151.4 ± 17.4253.1 ± 18.41
Sex: Female, Male
Sex: Female, Male(Participants)146-9251 CreamVehicle CreamTotal
Female191231
Male212849
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)146-9251 CreamVehicle CreamTotal
Hispanic or Latino336
Not Hispanic or Latino373774
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)146-9251 CreamVehicle CreamTotal
American Indian or Alaska Native000
Asian347
Native Hawaiian or Other Pacific Islander000
Black or African American257
White333063
More than one race112
Unknown or Not Reported101
Investigator's Global Assessment (IGA) Score
Investigator's Global Assessment (IGA) Score(Participants)146-9251 CreamVehicle CreamTotal
3-Moderate303161
4-Severe10919
07

Study locations

7 sites
  • Crown investigative site 01
    San Diego, California 92123, United States
  • Crown Investigative site 07
    Plainfield, Indiana 46168, United States
  • Crown Investigative site 08
    Metairie, Louisiana 70006, United States
  • Crown Investigative site 02
    Fridley, Minnesota 55432, United States
  • Crown Investigative site 04
    Columbia, Missouri 65212, United States
  • Crown Investigative Site 05
    Albuquerque, New Mexico 87106, United States
  • Crown Investigative site 06
    High Point, North Carolina 27262, United States
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jul 17, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03173547
Lead sponsor
Crown Laboratories, Inc.
Responsible party
Sponsor
First posted
Jun 2, 2017
Start date
Apr 25, 2017
Primary completion
Apr 30, 2019
Completion
Jul 31, 2019
Results posted
Jul 14, 2021
Last update
Aug 10, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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