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A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris

Primary Purpose

Ichthyosis Vulgaris

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
146-9251 cream
Vehicle cream
Sponsored by
Crown Laboratories, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ichthyosis Vulgaris

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Crown investigative site 01
  • Crown Investigative site 07
  • Crown Investigative site 08
  • Crown Investigative site 02
  • Crown Investigative site 04
  • Crown Investigative Site 05
  • Crown Investigative site 06

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

146-9251 cream

Vehicle cream

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
May 30, 2017
Last Updated
August 6, 2021
Sponsor
Crown Laboratories, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03173547
Brief Title
A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2017 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crown Laboratories, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ichthyosis Vulgaris

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
146-9251 cream
Arm Type
Active Comparator
Arm Description
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Arm Title
Vehicle cream
Arm Type
Placebo Comparator
Arm Description
Topical cream to be applied two times daily to specified treatment areas for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
146-9251 cream
Intervention Description
146-9251 cream contains an active drug and is applied topically.
Intervention Type
Drug
Intervention Name(s)
Vehicle cream
Intervention Description
Vehicle cream does not contain an active drug and is applied topically.
Primary Outcome Measure Information:
Title
Treatment Success
Description
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 Pre-specified Outcome Measures:
Title
Adverse Events (AEs)
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is a male or female and is at least 12 years old at the time of enrollment. 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. 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. 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. Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit. 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. 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.
Facility Information:
Facility Name
Crown investigative site 01
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Crown Investigative site 07
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Crown Investigative site 08
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Crown Investigative site 02
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Crown Investigative site 04
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Crown Investigative Site 05
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Crown Investigative site 06
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris

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