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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02993328




Registration number
NCT02993328
Ethics application status
Date submitted
7/12/2016
Date registered
15/12/2016
Date last updated
17/01/2019

Titles & IDs
Public title
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for Treatment of Plaque Psoriasis in Adults
Scientific 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
Secondary ID [1] 0 0
SAN021-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - SAN021 Serum
Treatment: Drugs - SAN021 Placebo

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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety measured by Adverse Events - Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.
Timepoint [1] 0 0
Total from Baseline to Day 43
Primary outcome [2] 0 0
Number of patients reporting discomfort during or immediately following SAN021 application - Tolerability will be based on the number of patients reporting discomfort during or immediately following application of SAN021.
Timepoint [2] 0 0
Patient reported from Baseline to Day 43
Primary outcome [3] 0 0
Patients achieving a Physician's Global Assessment of "clear" or "almost clear" at any time-point from Baseline to day 43 of the study. - 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.
Timepoint [3] 0 0
Any time-point from Baseline to Day 43
Secondary outcome [1] 0 0
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. - Percentage of patients achieving at least a 1-grade improvement in Physicians Global Assessment score.
Timepoint [1] 0 0
Any time-point from Baseline to Day 43
Secondary outcome [2] 0 0
Patients achieving a Psoriasis Area and Severity Index Score Improvement = 25% at any time-point from Baseline to Day 43 of the study. - 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.
Timepoint [2] 0 0
Any time-point from Baseline to Day 43
Secondary outcome [3] 0 0
Patients achieving a two grade improvement in Physicians Global Assessment score at 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.
Timepoint [3] 0 0
Any time-point from Baseline to Day 43 of the study
Secondary outcome [4] 0 0
Patients achieving a Psoriasis Area and Severity Index Score Improvement =50% at 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.
Timepoint [4] 0 0
Any time-point from Baseline to Day 43 of the study.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Dermatology West - Fremantle
Recruitment postcode(s) [1] 0 0
6160 - Fremantle

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Santalis Pharmaceuticals, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Fremantle Dermatology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
ClinDatrix, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02993328
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02993328