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A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03173547
Recruitment Status : Active, not recruiting
First Posted : June 2, 2017
Last Update Posted : April 1, 2019
Sponsor:
Information provided by (Responsible Party):
Crown Laboratories, Inc.

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).

Condition or disease Intervention/treatment Phase
Ichthyosis Vulgaris Drug: 146-9251 cream Drug: Vehicle cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Placebo controlled
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : April 25, 2017
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : November 2019


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.




Primary Outcome Measures :
  1. Treatment success [ Time Frame: Day 43 (6 weeks) ]
    Proportion of subjects 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 subject's disease, taking into account all of the subject's scaling, erythema, and fissuring in the Treatment Area.


Other Outcome Measures:
  1. Adverse Events (AEs) [ Time Frame: Day 0 through study completion, average 6 weeks, Day 43. ]
    AEs will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173547


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

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Responsible Party: Crown Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03173547     History of Changes
Other Study ID Numbers: 146-9251-201
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: April 1, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ichthyosis
Ichthyosis, Lamellar
Ichthyosis Vulgaris
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis
Skin Diseases
Ichthyosiform Erythroderma, Congenital
Skin Diseases, Genetic
Genetic Diseases, Inborn