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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02871479
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : January 17, 2019
Sponsor:
Collaborators:
ClinDatrix, Inc.
Texas Dermatology and Laser Specialists
Clinical Trials of Texas, Inc.
Derm Research, PLLC
Progressive Clinical Research
U.S. Dermatology Partners Bryan
Information provided by (Responsible Party):
Santalis Pharmaceuticals, Inc.

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Eczema Drug: SAN007 5% cream Drug: Placebo Drug: SAN007 10% cream Phase 2

Detailed Description:

Subjects will enter the Screening Period once the informed consent/ascent and photographic consent process has been completed. Subjects 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 subject eligibility is confirmed and the screening procedures completed, the subject will start the Treatment Period of the study. All enrolled subjects will receive either 5% SAN007 cream or placebo cream (randomized in a 2:1 ratio) OR 10% SAN007 cream or placebo cream (randomized in a 2:1 ratio) with the first dose applied at Visit 1 Baseline. Subjects will be instructed on how to apply the study medication twice daily for 28 days. Subjects will return to the clinic on Study Days 7,14 and 28 for study-related assessments. Subjects 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 subjects reporting discomfort during or immediately following application of SAN007. This will also be recorded as an AE. The study exclusion areas are not to be included 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, subjects will return to the study site according to the study schedule for interim assessments and recording of concomitant medication and adverse events (AEs).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Randomized, Placebo-Controlled, Safety, Tolerability, and Efficacy Trial of a Novel Botanical Drug Product Containing East Indian Sandalwood Oil (EISO) For The Treatment of Atopic Dermatitis
Actual Study Start Date : April 21, 2017
Actual Primary Completion Date : August 31, 2018
Actual Study Completion Date : August 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: SAN007 5% cream
A cream containing 5% East Indian sandalwood oil (EISO).
Drug: SAN007 5% cream
5% EISO in a cream formulation applied twice a day for up to 28 days.
Other Names:
  • Albuterpenoids
  • East Indian sandalwood oil (EISO)

Placebo Comparator: Placebo cream
The vehicle cream
Drug: Placebo
A placebo cream containing the same components as the vehicle for the active intervention arm
Other Name: vehicle cream

Experimental: SAN007 10% cream
A cream containing 10% East Indian Sandalwood Oil (EISO).
Drug: SAN007 10% cream
10% EISO in a cream formulation applied twice a day for up to 28 days.
Other Names:
  • Albuterpenoids
  • East Indian Sandalwood Oil (EISO)




Primary Outcome Measures :
  1. Safety Measured by Adverse Events [ Time Frame: 28 days ]
    Safety will be assessed by evaluating adverse events (AEs) with respect to severity, duration, and relationship to study drug.

  2. Number of subjects reporting discomfort during or immediately following SAN007 application [ Time Frame: 28 days ]
    Tolerability will be based on the number of subjects reporting discomfort during or immediately following application of SAN007.


Secondary Outcome Measures :
  1. Percentage of subjects who achieve an Improvement in Investigator Global Assessment Score [ Time Frame: 28 days ]
    The number of subjects achieving an Investigator Global Assessment of "clear" or "almost clear" at any time point during therapy.

  2. Percentage of subjects who have a ≥ 25% reduction in the Eczema Area and Severity Index (EASI) score [ Time Frame: 28 days ]
    Percentage of subjects who have a ≥ 25% reduction in the Eczema Area and Severity Index (EASI) score at any point during the trial.

  3. Percentage of subjects who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score [ Time Frame: 28 days ]
    Percentage of subjects who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score at any point during the trial.

  4. Percentage of subjects achieving at least a 1-grade improvement in Investigator Global Assessment score [ Time Frame: 28 days ]
    Percentage of subjects achieving at least a 1-grade improvement in Investigator Global Assessment score

  5. Percentage of subjects who have at least a 20% reduction in BSA affected by atopic dermatitis. [ Time Frame: 28 days ]
    Percentage of subjects who have at least a 20% reduction in BSA affected by atopic dermatitis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be included in the trial if they meet all of the following criteria:

    1. Are at least 18 years 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 ≤15% today surface area (BSA).
    4. Have atopic dermatitis that has been clinically stable for ≥ 30-days 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 interventional clinical trial for the duration of this study.
    12. 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.

Exclusion Criteria:

  • Subjects will be excluded from the trial if they meet any of the following criteria:

    1. Have a sibling or immediate family member already participating in this trial.
    2. 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%)
    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% or >15% total BSA of atopic dermatitis involvement in the target treatment area(s).
    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 60 days prior to Screening.
    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, within 60 days prior to the Baseline visit.
    13. Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years,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 2 years.
    17. Require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
    18. Have an active infection of any kind at Visit 1 (Baseline)
    19. Have an occupation that requires ≥50% of time be spent outdoors, where prolonged exposure to ultraviolet radiation is unavoidable.

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): NCT02871479


Locations
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United States, Texas
DermResearch
Austin, Texas, United States, 78759
J&S Sudies Pharmaceutical
Bryan, Texas, United States, 77845
Progressive Clinical Research
San Antonio, Texas, United States, 78213
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Clinical Trials of Texas
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Santalis Pharmaceuticals, Inc.
ClinDatrix, Inc.
Texas Dermatology and Laser Specialists
Clinical Trials of Texas, Inc.
Derm Research, PLLC
Progressive Clinical Research
U.S. Dermatology Partners Bryan
Investigators
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Principal Investigator: John Browning, MD Texas Dermatology and Laser Specialists

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Responsible Party: Santalis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02871479     History of Changes
Other Study ID Numbers: SAN007-02
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Santalis Pharmaceuticals, Inc.:
Atopic Dermatitis
Eczema

Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases