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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03837743
Other study ID # C928-015
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 21, 2019
Est. completion date May 20, 2020

Study information

Verified date August 2022
Source Durect
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This Phase 2 study has been designed to determine and compare the safety, tolerability, and efficacy of DUR-928 topical solution with that of the vehicle topical solution when applied once daily for approximately four weeks in subjects with plaque psoriasis. Subjects will be instructed (randomly assigned) to apply DUR-928 solution to a target lesion on one arm and vehicle solution to a target lesion on the opposite arm once daily for up to four weeks. Subjects will occlude the treated areas for approximately two hours after each application.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date May 20, 2020
Est. primary completion date November 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject is a male or non-pregnant female 18 years of age or older. 2. Subject has provided written informed consent. 3. Subject has a clinical diagnosis of stable mild to moderate plaque psoriasis for at least two months. 4. Females must be post-menopausal, surgically sterile, or use an effective method of birth control. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 2/Baseline. 5. Males (or their female partner) must agree to use an effective method of birth control throughout the study. 6. Subject has two similar contralateral Target Plaques. 7. Subject is 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. 8. Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of the plaque psoriasis or exposes the subject to an unacceptable risk by study participation. Exclusion Criteria: 1. Subject is pregnant, lactating, or is planning to become pregnant during the study. 2. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. 3. Subject has guttate, pustular, erythrodermic, inverse, or other non-plaque forms of psoriasis. 4. Subject has psoriasis beyond the two Target Plaques that, in the investigator's opinion, could not be reasonably managed with only a bland emollient during the study. 5. Subject is currently enrolled in an investigational drug or device study. 6. Subject has been previously enrolled in this study and treated with test article. Other protocol-defined inclusion and exclusion criteria assessed by the study staff may apply.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
DUR-928 Topical Solution
Topical solution containing active drug
Vehicle Topical Solution
Topical solution containing no active drug

Locations

Country Name City State
United States Site 04 Miami Florida
United States Site 02 Plainfield Indiana
United States Site 01 San Diego California
United States Site 03 Spokane Washington
United States Site 05 Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Durect Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other The Change From Baseline as Assessed on the Target Plaque Comparison The Target Plaque Comparison is scored on a 3-point scale: 1A = Target Plaque A is better than Target Plaque B, 0 = Target Plaque A is the same as Target Plaque B, and 1B = Target Plaque A is worse than Target Plaque B. Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Primary The Change From Baseline as Assessed on the Investigator's Global Assessment (IGA) Score. The IGA of the Target Plaques will be determined on a 5-point scale. 0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Secondary The Change From Baseline as Assessed on the Clinical Signs of Psoriasis (Plaque Elevation, Scaling, and Erythema) Each clinical sign (plaque elevation, scaling, erythema) will be graded on a 5-point scale.0=Clear; 1=Almost Clear; 2=Mild; 3=Moderate; 4=Severe. Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Secondary The Change From Baseline as Assessed on the Local Psoriasis Severity Index (LPSI) The LPSI is a sum of all three parameters (sum range of 0-12, with 12 being a worse outcome). Three parameters are plaque elevation, scaling, and erythema, each rated 0-4, 0=clear to 4=severe. Up to Day 57 (assessed at Baseline, and Weeks 1,2,3,4,5,7,8, change from baseline to week 4 and 8 reported)
Secondary The Change From Baseline as Assessed by the Target Plaque Area. The surface areas of Target Plaque A (plaque on left arm) and Target Plaque B (plaque on right arm) will be measured. Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
Secondary The Change From Baseline as Assessed on the Itch Numeric Rating Scale (I-NRS) for Pruritus. The I-NRS score is based on an 11-point scale where 0 represents "no itching" and 10 represents "worst itch imaginable." Up to Day 57 (assessed at Baseline, and Weeks 2,4,8, change from baseline to week 4 and 8 reported)
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