NCT03000608

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

A Double-Blind, Multi-Center, Randomized, Placebo Controlled Safety, Tolerability & Efficacy Trial Of A New Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment Of Mild-To-Moderate Plaque Psoriasis In Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Santalis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2017-05-17
• Primary completion: 2017-12-13
• Completion: 2017-12-14
• First posted: 2016-12-22
• Last updated: 2019-05-29
• Results posted: 2019-05-29

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study