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Atopic DermatitisPhase 2NCT03000595

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

A Phase 2 study testing SAN007 Cream in people with Atopic Dermatitis, run by Santalis Pharmaceuticals, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

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 from 3 months to 65 years of age, with atopic dermatitis. Read more about this study

Who is it for?
Ages 3 months to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
SAN007 Cream
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2018to Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

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 3 months to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Are at least 3 months 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 ≤10% body surface area (BSA).
  • Have atopic dermatitis that has been clinically stable for ≥ 1 month 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.
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  • 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 clinical trial for the duration of this study.
  • 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.
  • 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.

Who cannot join

  • Have a sibling or immediate family member already participating in this trial.
  • Currently requires and/or, in the past month, has required topical use of a medium or high potency steroid.
  • Atopic dermatitis that, in the opinion of the investigator, is likely to stem from an allergic reaction. (i.e. contact dermatitis)
  • Have <2% of atopic dermatitis involvement eligible for treatment.
  • 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.).
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  • Have received phototherapy within the last 2 months prior to enrollment.
  • 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, with no improvement in condition, within 60 days prior to the Baseline visit.
  • Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, 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 two years.
  • Require greater than 2.0 mg/day inhaled or intranasal corticosteroids.
  • Have an active infection of any kind at Baseline
  • Have an occupation that requires ≥50% of time be spent outdoors, where prolonged exposure to ultraviolet radiation is unavoidable.

About this study

Official title: 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.

Read the 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).

Being tested
SAN007 Cream, Placebo
Keywords
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 CreamDrug

    Also called Active

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

  • PlaceboDrug

    Also called SAN007 Placebo Cream

    The vehicle cream

Study groups in NCT03000595
Study groupRoleWhat they receive
SAN007 CreamExperimentalA cream containing 5% East Indian sandalwood oil (EISO).
Receives: Drug: SAN007 Cream
PlaceboPlacebo comparatorA placebo cream containing the same components as the vehicle for the active intervention arm
Receives: Drug: Placebo

What is being measured

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

  1. 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.

    Measured: 28 days

  2. 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.

    Measured: 28 Days

Secondary outcomes (5)

  1. 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

    Measured: 28 Days

  2. 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.

    Measured: 28 days

  3. 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.

    Measured: 28 Days

  4. 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

    Measured: 28 Days

  5. 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.

    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 posted22 Dec 2016 (estimated)
  2. Study startJun 2018 (estimated)
  3. Primary completionJan 2019 (estimated)
  4. Study completionJan 2019 (estimated)

Why it stopped: Study location changed

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03000595
Sponsor's protocol ID
SAN007-03
Status last verified
Jan 2019
First submitted
16 Dec 2016
Last updated
17 Jan 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAN007 Cream in people with Atopic Dermatitis, run by Santalis Pharmaceuticals, Inc..

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 19 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: withdrawn, as of the sponsor's last update on 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Incidence of Treatment-Emergent Adverse Events (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT03000595.

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 17 Jan 2019.

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