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Atopic DermatitisPhase 2NCT02871479

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

A Phase 2 study testing SAN007 5% cream and SAN007 10% cream in people with Atopic Dermatitis and Eczema, run by Santalis Pharmaceuticals, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atopic Dermatitis, Eczema
What is being tested?
SAN007 5% cream and SAN007 10% cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
71 participants
Where
5 sitesUnited States
Study dates
21 Apr 2017to 31 Aug 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Have open sores or open lesions in the treatment area(s).
  • Have a history of alcohol or illegal drug/substance abuse, or suspected alcohol or illegal drug/substance abuse in the past 2 years.
  • Require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
  • Have an active infection of any kind at Visit 1 (Baseline)
  • Have an occupation that requires ≥50% of time be spent outdoors, where prolonged exposure to ultraviolet radiation is unavoidable.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • DermResearch

    Austin, Texas, 78759

  • J&S Sudies Pharmaceutical

    Bryan, Texas, 77845

  • Progressive Clinical Research

    San Antonio, Texas, 78213

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
SAN007 5% cream, Placebo, SAN007 10% cream
Keywords
Atopic Dermatitis, Eczema
Medical subject headings
Dermatitis, Atopic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAN007 5% creamDrug

    Also called Albuterpenoids, East Indian sandalwood oil (EISO)

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

  • PlaceboDrug

    Also called vehicle cream

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

  • SAN007 10% creamDrug

    Also called Albuterpenoids, East Indian Sandalwood Oil (EISO)

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

Study groups in NCT02871479
Study groupRoleWhat they receive
SAN007 5% creamExperimentalA cream containing 5% East Indian sandalwood oil (EISO).
Receives: Drug: SAN007 5% cream
Placebo creamPlacebo comparatorThe vehicle cream
Receives: Drug: Placebo
SAN007 10% creamExperimentalA cream containing 10% East Indian Sandalwood Oil (EISO).
Receives: Drug: SAN007 10% cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28 days

Secondary outcomes (1)

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

    Percentage of subjects who have a ≥ 50% reduction in the Eczema Area and Severity Index (EASI) score at any point during the trial. Minimum value is a 0 and a maximum value is 72. Higher score denoting worse than a lower score.

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Aug 2016 (estimated)
  2. Study start21 Apr 2017
  3. Primary completion31 Aug 2018
  4. Study completion31 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02871479
Sponsor's protocol ID
SAN007-02
Status last verified
May 2019
First submitted
11 Aug 2016
Last updated
29 May 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAN007 5% cream and SAN007 10% cream in people with Atopic Dermatitis and Eczema, run by Santalis Pharmaceuticals, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Adverse Events (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02871479.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.

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