A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Plaque Psoriasis in Adults

Study Purpose

This trial will be a double-blind, single-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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Are ≥18 but ≤65 years of age 2. Have a clinical diagnosis of mild-to-moderate plaque psoriasis, as defined by a Psoriasis Area and Severity Index (PASI) score between 2 and 12,36 appropriate for topical treatment that covers a minimum of 0.5% and a maximum of 10% Body Surface Area (BSA), in the permitted treatment areas. 3. Are willing to treat all psoriasis occurring in the permitted treatment areas with only SAN021 4. 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. 5. Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study. 6. 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. 7. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. 8. 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. 9. Are willing to avoid participation in any other clinical trial for the duration of this study. 10. Are willing to refrain from treating restricted areas, which will be excluded from all 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:

1. Have spontaneously improving or rapidly deteriorating plaque psoriasis, or pustular psoriasis as determined by the Investigator. 2. Have been treated, with prescription medication for plaque psoriasis, with no improvement in condition, within 60 days prior to the Baseline visit. 3. Are pregnant, breast-feeding, or planning to become pregnant during the study. 4. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, or any other confounding skin condition. 5. 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. 6. Have open sores or open lesions in the treatment area(s). 7. Have any condition that, in the opinion of the investigator, would confound the safety and/or efficacy assessments of plaque psoriasis. 8. Have participated in any interventional clinical trial in the previous 30 days. 9. 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.). 10. Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e., biologics), including oral or parenteral corticosteroids. 11. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years. 12. Plan to seek alternative treatment of any kind for their psoriasis, in the eligible treatment areas or otherwise, during the trial period.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02993328
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Santalis Pharmaceuticals, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry, Other
Overall Status Not yet recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Plaque Psoriasis
Additional Details

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 12,36 appropriate for topical treatment that covers a minimum of 0.5% 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 8, 15, 29 and a final visit on Day 43. On Study Day 50, subject will receive a Follow-up phone call and be queried for condition status since going off study.

Contact a Trial Team

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International Sites

Dermatology West, Fremantle, Western Australia, Australia

Status

Not yet recruiting

Address

Dermatology West

Fremantle, Western Australia, 6160

Site Contact

Ron Pensini

ron@fremantledermatology.com.au

0894304488

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