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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
A cream containing 5% East Indian sandalwood oil (EISO).
The vehicle cream
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.
Time frame: 28 days
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.
Time frame: 28 Days
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
Time frame: 28 Days
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.
Time frame: 28 days
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.
Time frame: 28 Days
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
Time frame: 28 Days
Percentage of patients who have at least a 20% reduction in BSA affected by atopic dermatitis.
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Percentage of patients who have at least a 20% reduction in BSA affected by atopic dermatitis.
Time frame: 28 Days