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

NCT02871479 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SAN007-02
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 5

Brief Summary

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 at least 18 years of age, with atopic dermatitis.

Conditions

Atopic Dermatitis; Eczema

Keywords

Atopic Dermatitis; Eczema

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events

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

  28 days

Secondary Outcomes (1)

• Percentage of Subjects Who Have a ≥ 50% Reduction in the Eczema Area and Severity Index (EASI) Score

  28 days

Study Arms (3)

SAN007 5% cream

EXPERIMENTAL

A cream containing 5% East Indian sandalwood oil (EISO).

Drug: SAN007 5% cream

Placebo cream

PLACEBO COMPARATOR

The vehicle cream

Drug: Placebo

SAN007 10% cream

EXPERIMENTAL

A cream containing 10% East Indian Sandalwood Oil (EISO).

Drug: SAN007 10% cream

Interventions

SAN007 5% cream DRUG

5% EISO in a cream formulation applied twice a day for up to 28 days.

Also known as: Albuterpenoids, East Indian sandalwood oil (EISO)

SAN007 5% cream

Placebo DRUG

A placebo cream containing the same components as the vehicle for the active intervention arm

Also known as: vehicle cream

Placebo cream

SAN007 10% cream DRUG

10% EISO in a cream formulation applied twice a day for up to 28 days.

Also known as: Albuterpenoids, East Indian Sandalwood Oil (EISO)

SAN007 10% cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be included in the trial if they meet all of the following criteria:
• Are at least 18 years of age
• Have atopic dermatitis, as determined by an EASI score of ≥5 and ≤50 (Hanifin, 2001)
• Total treatment area(s) of atopic dermatitis involvement ≥2% and ≤15% today surface area (BSA).
• Have atopic dermatitis that has been clinically stable for ≥ 30-days prior to the Screening Visit.
• 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.
• 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.
• 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.
• Are willing to refrain from exposure to artificial ultraviolet radiation for the duration of the study.
• Are willing to cover target treatment areas to avoid exposure to natural ultraviolet radiation for the duration of the study.
• 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.
• Are willing to avoid participation in any other interventional clinical trial for the duration of this study.
• Are willing to refrain from treating areas that are not in the defined treatment area(s), which will be excluded from the IGA assessments and BSA calculation. These areas are as follows: head, neck, soles of feet, palms of hands, axillae, or intertriginous areas.

You may not qualify if:

• Subjects will be excluded from the trial if they meet any of the following criteria:
• Have a sibling or immediate family member already participating in this trial.
• Currently requires and/or, in the 30 days prior to Screening, has required topical use of a medium or high potency steroid (i.e. \>1%)
• Atopic dermatitis that, in the opinion of the investigator, is likely to stem from an allergic reaction. (i.e. contact dermatitis)
• Have \<2% or \>15% total BSA of atopic dermatitis involvement in the target treatment area(s).
• Have participated in any interventional clinical trial in the previous 30 days to the screening visit.
• 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.).
• Have received phototherapy within the 60 days prior to Screening.
• 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).
• 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.
• Are pregnant, breast-feeding or plan to become pregnant at any point for the duration of the trial.
• 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.
• Have been treated, with prescription medication for atopic dermatitis, within 60 days prior to the Baseline visit.
• Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years,or any other confounding skin condition.
• 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.

Sponsors & Collaborators

• Santalis Pharmaceuticals, Inc.: lead
• ClinDatrix, Inc.: collaborator
• Texas Dermatology and Laser Specialists: collaborator
• Clinical Trials of Texas, Inc.: collaborator
• Derm Research, PLLC: collaborator
• Progressive Clinical Research: collaborator
• U.S. Dermatology Partners Bryan: collaborator

Study Sites (5)

DermResearch

Austin, Texas, 78759, United States

Location

J&S Sudies Pharmaceutical

Bryan, Texas, 77845, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218, United States

Location

Clinical Trials of Texas

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Paul Castella
• Organization: Santalis Pharmaceuticals

paulc@satalispharma.com

2103992316

Study Officials

• John Browning, MD

  Texas Dermatology and Laser Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 18, 2016
• Study Start: April 21, 2017
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: May 29, 2019
• Results First Posted: May 29, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)