A Trial of a Botanical Drug (EISO) for Treatment of Mild-to-Moderate Plaque Psoriasis

NCT ID: NCT03000608

Last Updated: 2019-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-17
• Study Completion Date: 2017-12-14

Brief Summary

This trial will be a double-blind, multi-center, randomized, placebo controlled study to evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of mild-to-moderate plaque psoriasis.

Detailed Description

Patients will enter the Screening Period once the informed consent and photographic consent process has been completed. Patients with mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical treatment that covers a minimum of 1.0% and a maximum of 10% BSA, in the permitted treatment areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.

Once subject eligibility is confirmed and the screening procedures completed, all enrolled subjects will start the Treatment Period of the study. All enrolled subjects will receive either 10% SAN021 or placebo serum (randomized in a 2:1 ratio) with the first dose applied at the Day 1 Study Visit. Subjects will be instructed on how to apply the study medication twice daily for 42 days.

Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28 and a final visit on Day 42. On Study Day 49, subject will receive a Follow-up phone call and be queried for condition status since going off study.

Conditions

Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SAN021 Serum

SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.

Group Type: EXPERIMENTAL

SAN021 Serum

Intervention Type: DRUG

SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.

SAN021 Placebo

SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.

Group Type: PLACEBO_COMPARATOR

SAN021 Placebo

Intervention Type: DRUG

SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.

Interventions

SAN021 Serum

SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.

Intervention Type: DRUG

SAN021 Placebo

SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.

Intervention Type: DRUG

Other Intervention Names

Active; Placebo Serum

Eligibility Criteria

Inclusion Criteria

• Are ≥18 but ≤65 years of age
• Have a clinical diagnosis of mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical treatment that covers a minimum of 1.0% and a maximum of 10% Body Surface Area (BSA), in the permitted treatment areas.
• Are willing to treat all psoriasis occurring in the permitted treatment areas with only SAN021
• Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
• Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
• Are willing to refrain from using any lotions, moisturizer, cleansers, cosmetics or creams, other than those issued as part of the study, on the treatment areas during the treatment period.
• If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study.
• Are able to give written informed consent in a manner approved by the Institutional Review Board or Ethics Review Committee and comply with the requirements of the study.
• Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
• Are willing to refrain from treating restricted areas, which will be excluded from the PGA assessments and Body Surface Area (BSA) calculation. These areas are as follows: head, neck, fingernails, toenails, soles of feet, and palms of hands, axillae, or intertriginous areas.

Exclusion Criteria

• Have spontaneously improving or rapidly deteriorating plaque psoriasis, or pustular psoriasis as determined by the Investigator.
• Have been treated, with prescription medication for plaque psoriasis, with no improvement in condition, within 60 days prior to the Baseline visit.
• Are pregnant, breast-feeding, or planning to become pregnant during the study.
• Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
• Are undergoing treatments with topical antipsoriatic drug products other than corticosteroids within 14 days prior to the Baseline Visit, and for therapy containing corticosteroids or retinoids within 28 days prior to Baseline Visit.
• Have open sores or open lesions in the treatment area(s).
• Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of plaque psoriasis.
• Have participated in any interventional clinical trial in the previous 30 days.
• Have a known sensitivity to any of the constituents of the test product including sensitivities to sandalwood oil, fragrances, or any member of the Compositae family of vascular plants (e.g., sunflowers, daisies, dahlias, etc.).
• Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids.
• Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
• Plan to seek alternative treatment of any kind for their psoriasis, in the eligible treatment areas or otherwise, during the trial period.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinDatrix, Inc.

INDUSTRY

Sponsor Role: collaborator

Clinical Trials of Texas, Inc.

OTHER

Sponsor Role: collaborator

Dermatology Research Center of San Antonio

UNKNOWN

Sponsor Role: collaborator

Derm Research, PLLC

OTHER

Sponsor Role: collaborator

Progressive Clinical Research

OTHER

Sponsor Role: collaborator

Santalis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DermResearch, Inc.

Austin, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Clinical Trial of Texas

San Antonio, Texas, United States

The Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SAN021-03

Identifier Type: -

Identifier Source: org_study_id