A Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis

A Double-Blind, Randomized, Placebo-Controlled, Safety, Tolerability, and Efficacy Trial of a Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment of Atopic Dermatitis

This trial will be a double-blind, randomized, placebo-controlled, safety, tolerability and efficacy trial of SAN007 (5% East Indian sandalwood oil in a cream formulation) treatment regimen when administered daily for up to 28 days to patients from 3 months to 65 years of age, with atopic dermatitis.

Study Overview

• Status: Withdrawn
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: SAN007 Cream; Drug: Placebo

Detailed Description

Patients will enter the Screening Period once the informed consent/ascent and photographic consent process has been completed. Patients with a total body surface area (BSA) of ≥2% and ≤ 15% atopic dermatitis involvement, in the treatable areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.

Once patient eligibility is confirmed and the screening procedures completed, the patient will start the Treatment Period of the study. All enrolled patients will receive either 5% SAN007 cream or placebo cream (randomized in a 2:1 ratio) with the first dose applied at the Day 1 Study Visit. Patients and/or their legally authorized representative will be instructed on how to apply the study medication twice daily for 28 days. Patients will return to the clinic on Study Days 7,14 and 28 for study-related assessments. Patients and/or their LAR will receive a telephone contact from the site, on Study Days 21 and 35.

Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.

In addition cutaneous tolerability will be evaluated at each visit. Tolerability evaluation will be based on patients reporting discomfort during or immediately following application of SAN007. This will also be recorded as an AE. The study exclusion areas are to be not to be used in this evaluation.

Efficacy will be assessed at each study visit through the completion of the IGA, EASI and BSA calculation.

During the active treatment period, Patients will return to the study site according to the study schedule for interim assessments and recording of concomitant medication and adverse events (AEs).

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 63 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Are at least 3 months of age
2. Have atopic dermatitis, as determined by an EASI score of ≥5 and ≤50 (Hanifin, 2001)
3. Total treatment area(s) of atopic dermatitis involvement ≥2% and ≤10% body surface area (BSA).
4. Have atopic dermatitis that has been clinically stable for ≥ 1 month prior to the Screening Visit.
5. Are able to obtain written informed consent/ascent in a manner approved by the Institutional Review Board and comply with the requirements 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 target treatment areas during the treatment period.
7. 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.
8. Are willing to refrain from exposure to artificial ultraviolet radiation for the duration of the study.
9. Are willing to cover target treatment areas to avoid exposure to natural ultraviolet radiation for the duration of the study.
10. If female of childbearing potential, must be willing to practice an acceptable form of birth control for the duration of the study. i.e. barrier method, hormone or intrauterine device.
11. Are willing to avoid participation in any other clinical trial for the duration of this study.
12. Are willing to refrain from treating areas that are not the defined treatment area(s), which will be excluded from all assessments and BSA calculation.
13. Are willing to refrain from treating study restricted areas. Study restricted areas are as follows: head, neck, soles of feet, palms of hands, axillae, or intertriginous areas.

Exclusion Criteria:

1. Have a sibling or immediate family member already participating in this trial.
2. Currently requires and/or, in the past month, has required topical use of a medium or high potency steroid.
3. Atopic dermatitis that, in the opinion of the investigator, is likely to stem from an allergic reaction. (i.e. contact dermatitis)
4. Have <2% of atopic dermatitis involvement eligible for treatment.
5. Have participated in any interventional clinical trial in the previous 30 days to the screening visit.
6. 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.).
7. Have received phototherapy within the last 2 months prior to enrollment.
8. Have received any systemic medication for atopic dermatitis in the past 2 months that would interfere with the evaluation of atopic dermatitis (excluding antihistamines or leukotriene inhibitors).
9. Have a present condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
10. Are pregnant, breast-feeding or plan to become pregnant at any point for the duration of the trial.
11. Are not willing to practice an approved form of birth control while on the study drug for the duration of the trial. i.e. barrier method, hormone or intrauterine device.
12. Have been treated, with prescription medication for atopic dermatitis, with no improvement in condition, within 60 days prior to the Baseline visit.
13. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, or any other confounding skin condition.
14. Have undergone treatments with topical atopic dermatitis drug products, other than retinoids or corticosteroids, within 14 days prior to the Baseline Visit, and for therapy containing corticosteroids or retinoids within 28 days prior to Baseline Visit.
15. Have open sores or open lesions in the treatment area(s).
16. Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past two years.
17. Require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
18. Have an active infection of any kind at Baseline
19. Have an occupation that requires ≥50% of time be spent outdoors, where prolonged exposure to ultraviolet radiation is unavoidable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SAN007 Cream; A cream containing 5% East Indian sandalwood oil (EISO).	Drug: SAN007 Cream; A cream containing 5% East Indian sandalwood oil (EISO).; Other Names: Active
Placebo Comparator: Placebo; A placebo cream containing the same components as the vehicle for the active intervention arm	Drug: Placebo; The vehicle cream; Other Names: SAN007 Placebo Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events	Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.	28 days
Incidence of Irritation or Rash at the Site of Application of the Study Medication	The percentage of patients reporting discomfort either during or immediately following the application of SAN007.	28 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Patients who Achieve an Improvement in Investigator Global Assessment Score	The number of patients achieving an Investigator Global Assessment of "clear" or "almost clear" at any time point during therapy	28 Days
Percentage of Patients who have a ≥ 25% reduction in the Eczema Area and Severity Index (EASI) score	Percentage of patients who have a ≥ 25% reduction in the Eczema Area and Severity Index (EASI) score at any point during the trial.	28 days
Percentage of Patients who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score	Percentage of patients who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score at any point during the trial.	28 Days
Percentage of patients achieving at least a 1-grade improvement in Investigator Global Assessment score	Percentage of patients achieving at least a 1-grade improvement in Investigator Global Assessment score	28 Days
Percentage of patients who have at least a 20% reduction in BSA affected by atopic dermatitis.	Percentage of patients who have at least a 20% reduction in BSA affected by atopic dermatitis.	28 Days

Collaborators and Investigators

• Sponsor: Santalis Pharmaceuticals, Inc.
• Collaborators: ClinDatrix, Inc.; Fremantle Dermatology

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: December 16, 2016
• First Submitted That Met QC Criteria: December 19, 2016
• First Posted (Estimate): December 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: eczema
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: SAN007-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No