Trial Outcomes & Findings for A Trial of a Botanical Drug (EISO) for Treatment of Mild-to-Moderate Plaque Psoriasis (NCT NCT03000608)

NCT ID: NCT03000608

Last Updated: 2019-05-29

Results Overview

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 42 days of therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 69 participants
• Primary outcome timeframe: Any time-point from Baseline to Day 42
• Results posted on: 2019-05-29

Participant Flow

Participant milestones

Measure	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. 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.	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. 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.
Overall Study STARTED	46	23
Overall Study COMPLETED	40	19
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	SAN021 Serum n=46 Participants 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 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.	SAN021 Placebo n=23 Participants 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. 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.	Total n=69 Participants Total of all reporting groups
Age, Continuous	43.8 years STANDARD_DEVIATION 11.78 • n=5 Participants	47.0 years STANDARD_DEVIATION 11.96 • n=7 Participants	44.9 years STANDARD_DEVIATION 11.85 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	13 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	10 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized White	44 participants n=5 Participants	23 participants n=7 Participants	67 participants n=5 Participants
Race/Ethnicity, Customized American Indian/ Alaskan Native	2 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants
Region of Enrollment United States	46 participants n=5 Participants	23 participants n=7 Participants	69 participants n=5 Participants
Height	169.93 cm STANDARD_DEVIATION 8.804 • n=5 Participants	165.48 cm STANDARD_DEVIATION 12.9841 • n=7 Participants	168.45 cm STANDARD_DEVIATION 10.446 • n=5 Participants
Weight	96.62 kg STANDARD_DEVIATION 27.863 • n=5 Participants	84.58 kg STANDARD_DEVIATION 18.352 • n=7 Participants	92.61 kg STANDARD_DEVIATION 25.601 • n=5 Participants

PRIMARY outcome

Timeframe: Any time-point from Baseline to Day 42

Population: The analysis population for this outcome measure is the FAS set.

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 42 days of therapy.

Outcome measures

Measure	SAN021 Serum n=45 Participants 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 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.	SAN021 Placebo n=21 Participants 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. 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.
Patients Achieving a Physician's Global Assessment of "Clear" or "Almost Clear" at Any Time-point From Baseline to Day 42 of the Study	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Any time-point from Baseline to Day 42 of the study.

Population: The analysis set used for this outcome measure is the FAS set.

Percentage of patients who have a ≥50% reduction in the Psoriasis Area Severity Index (PASI) score at any time-point from Baseline to Day 42 of the study.

Outcome measures

Measure	SAN021 Serum n=45 Participants 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 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.	SAN021 Placebo n=21 Participants 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. 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.
Patients Achieving a Psoriasis Area and Severity Index Score Improvement ≥50% at Any Time-point From Baseline to Day 42 of the Study.	6 Participants	1 Participants

Adverse Events

SAN021 Serum

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

SAN021 Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	SAN021 Serum n=46 participants at risk 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 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.	SAN021 Placebo n=23 participants at risk 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. 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.
Infections and infestations Subcutaneous Abcess	2.2% 1/46 • Over the course of the trial, AE information was collected. The trial was a 42 day trial.	0.00% 0/23 • Over the course of the trial, AE information was collected. The trial was a 42 day trial.
Infections and infestations Pneumonia	2.2% 1/46 • Over the course of the trial, AE information was collected. The trial was a 42 day trial.	0.00% 0/23 • Over the course of the trial, AE information was collected. The trial was a 42 day trial.

Other adverse events

Measure	SAN021 Serum n=46 participants at risk 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 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.	SAN021 Placebo n=23 participants at risk 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. 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.
Skin and subcutaneous tissue disorders Pruritis	8.7% 4/46 • Over the course of the trial, AE information was collected. The trial was a 42 day trial.	0.00% 0/23 • Over the course of the trial, AE information was collected. The trial was a 42 day trial.

Additional Information

Dr. Paul Castella

Santalis Pharmaceuticals

Phone: 2103992316

Email: paulc@santalispharmaceuticals.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60