A Six Week Topical Cream Study for Subjects With Ichthyosis Vulgaris

NCT03173547 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 146-9251-201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 7

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).

Conditions

Ichthyosis Vulgaris

Outcome Measures

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).

  Day 43 (6 weeks)

Other Outcomes (1)

• Adverse Events (AEs)

  Day 0 through study completion, average 6 weeks, Day 43.

Study Arms (2)

146-9251 cream

ACTIVE COMPARATOR

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

Drug: 146-9251 cream

Vehicle cream

PLACEBO COMPARATOR

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

Drug: Vehicle cream

Interventions

146-9251 cream DRUG

146-9251 cream contains an active drug and is applied topically.

146-9251 cream

Vehicle cream DRUG

Vehicle cream does not contain an active drug and is applied topically.

Vehicle cream

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. Subject is pregnant, lactating, or is planning to become pregnant during the study.
• \. 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.
• \. 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.
• \. Subject has used systemic corticosteroids within 4 weeks or retinoids within 24 weeks prior to the initiation of treatment.
• \. Subject has stable use of vitamin or herbal supplements for less than 2 weeks prior to the initiation of treatment.
• \. Subject has a history of sensitivity to any of the ingredients in the test articles.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Crown Laboratories, Inc.: lead

Study Sites (7)

Crown investigative site 01

San Diego, California, 92123, United States

Location

Crown Investigative site 07

Plainfield, Indiana, 46168, United States

Location

Crown Investigative site 08

Metairie, Louisiana, 70006, United States

Location

Crown Investigative site 02

Fridley, Minnesota, 55432, United States

Location

Crown Investigative site 04

Columbia, Missouri, 65212, United States

Location

Crown Investigative Site 05

Albuquerque, New Mexico, 87106, United States

Location

Crown Investigative site 06

High Point, North Carolina, 27262, United States

Location

MeSH Terms

Conditions

Ichthyosis Vulgaris

Condition Hierarchy (Ancestors)

Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Therapeutics, Inc.

ClinicalResearch@therapeuticsinc.com

858-571-1800

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo controlled

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 2, 2017
• Study Start: April 25, 2017
• Primary Completion: April 30, 2019
• Study Completion: July 31, 2019
• Last Updated: August 10, 2021
• Results First Posted: July 14, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)