A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris

A Randomized, Double-blind, Vehicle-controlled Study to Evaluate the Safety and Efficacy of 146-9251 Cream Applied Twice-daily for Six Weeks in Subjects With Ichthyosis Vulgaris

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).

Study Overview

• Status: Completed
• Conditions: Ichthyosis Vulgaris
• Intervention / Treatment: Drug: 146-9251 cream; Drug: Vehicle cream

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 146-9251 cream; Topical cream to be applied two times daily to specified treatment areas for 6 weeks.	Drug: 146-9251 cream; 146-9251 cream contains an active drug and is applied topically.
Placebo Comparator: Vehicle cream; Topical cream to be applied two times daily to specified treatment areas for 6 weeks.	Drug: Vehicle cream; Vehicle cream does not contain an active drug and is applied topically.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Day 43 (6 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	AEs will be assessed by the investigator and the number of participants with any local and systemic AEs will be reported.	Day 0 through study completion, average 6 weeks, Day 43.

Collaborators and Investigators

• Sponsor: Crown Laboratories, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 31, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 10, 2021
• Last Update Submitted That Met QC Criteria: August 6, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Congenital Abnormalities; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Skin Diseases, Genetic; Skin Abnormalities; Keratosis; Ichthyosiform Erythroderma, Congenital; Ichthyosis; Ichthyosis, Lamellar; Ichthyosis Vulgaris
• Other Study ID Numbers: 146-9251-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No