A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) For Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: SAN007 5% cream; Placebo; SAN007 10% cream
Intervention description: 5% EISO in a cream formulation applied twice a day for up to 28 days.; A placebo cream containing the same components as the vehicle for the active intervention arm; 10% EISO in a cream formulation applied twice a day for up to 28 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Eczema

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.
    

Eligibility 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.