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Trial record 2 of 2 for:    EISO | psoriasis

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

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ClinicalTrials.gov Identifier: NCT02993328
Recruitment Status : Not yet recruiting
First Posted : December 15, 2016
Last Update Posted : February 8, 2018
Sponsor:
Collaborators:
Fremantle Dermatology
ClinDatrix, Inc.
Information provided by (Responsible Party):
Santalis Pharmaceuticals, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Plaque Psoriasis Drug: SAN021 Serum Drug: SAN021 Placebo Phase 2

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 12,36 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo Controlled Safety, Tolerability & Efficacy Trial Of A New Botanical Drug Product At One Dose Level For The Treatment Of Mild-To-Moderate Plaque Psoriasis In Adult Subjects
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Experimental: 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 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.
Other Name: Active

Placebo Comparator: 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.
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.
Other Name: Placebo Serum




Primary Outcome Measures :
  1. Safety measured by Adverse Events [ Time Frame: Total from Baseline to Day 43 ]
    Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.

  2. Number of patients reporting discomfort during or immediately following SAN021 application [ Time Frame: Patient reported from Baseline to Day 43 ]
    Tolerability will be based on the number of patients reporting discomfort during or immediately following application of SAN021.

  3. Patients achieving a Physician's Global Assessment of "clear" or "almost clear" at any time-point from Baseline to day 43 of the study. [ Time Frame: Any time-point from Baseline to Day 43 ]
    The primary preliminary efficacy endpoint will be number of patients achieving a Physician's Global Assessment of "clear" or "almost clear" at any time-point during the 43 days of therapy.


Secondary Outcome Measures :
  1. Patients achieving at least a one grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study. [ Time Frame: Any time-point from Baseline to Day 43 ]
    Percentage of patients achieving at least a 1-grade improvement in Physicians Global Assessment score.

  2. Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥ 25% at any time-point from Baseline to Day 43 of the study. [ Time Frame: Any time-point from Baseline to Day 43 ]
    percentage of patients who have a ≥ 25% reduction in the Psoriasis Area and Severity Index (PASI) score at any time-point from Baseline to Day 43 of the study.

  3. Patients achieving a two grade improvement in Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study. [ Time Frame: Any time-point from Baseline to Day 43 of the study ]
    percentage of patients achieving a 2-grade improvement in the Physicians Global Assessment score at any time-point from Baseline to Day 43 of the study.

  4. Patients achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at any time-point from Baseline to Day 43 of the study. [ Time Frame: Any time-point from Baseline to Day 43 of the study. ]
    percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 43 of the study.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02993328


Contacts
Contact: Paul Castella, PhD 210-399-2316 paul@santalispharma.com
Contact: Corey Levenson, PhD 210-399-2317 corey@santalispharma.com

Locations
Australia, Western Australia
Dermatology West Not yet recruiting
Fremantle, Western Australia, Australia, 6160
Contact: Ron Pensini    0894304488    ron@fremantledermatology.com.au   
Contact: Somer Baburek    2103992322    somer@santalispharma.com   
Principal Investigator: Kurt Gebauer, MBBSFACDFACP         
Sponsors and Collaborators
Santalis Pharmaceuticals, Inc.
Fremantle Dermatology
ClinDatrix, Inc.

Responsible Party: Santalis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02993328     History of Changes
Other Study ID Numbers: SAN021-02
First Posted: December 15, 2016    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases