A Study to Investigate Safety and Efficacy of Tapinarof Cream, 1% in Participants Ages 3 Months to < 24 Months With Atopic Dermatitis

Tapinarof cream, 1%, applied topically once daily

Drug: Tapinarof cream, 1%

Vehicle cream is applied topically once daily for up to 8-weeks.

Drug: Vehicle Cream

Tapinarof cream, 1%: Applied topically once daily to lesions on participant's skin during the Double-Blind period. During the Open-Label Period, it will be applied once daily to lesions, as needed.

Applied topically once daily to lesions on participant's skin during the Double-Blind period.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

The vIGA-AD is a global assessment of the current state of the disease. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.

Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks.

The vIGA-AD is a clinical tool for assessing the current state/severity of a subject's atopic dermatitis at a given timepoint.. It is a static 5-point scale used to grade overall disease severity (scalp excluded), as determined by the investigator, using the clinical characteristics of erythema, induration/papulation, lichenification, oozing/crusting. The vIGA-AD ranges from 0 to 4 and is reported as Clear (0), Almost clear (1), Mild (2), Moderate (3), and Severe (4). Higher vIGA-AD scores represent more severe disease.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the %BSA affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the %BSA involved for each body region relative to the whole body. The subject's scalp is excluded from this assessment. A higher EASI score represents more severe disease.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

Assessment of %BSA is an estimate of the percentage of total involved skin with atopic dermatitis. Estimates were made using the handprint method, where the full palmar hand of the participant (fully extended palm, fingers and thumbs together) represented approximately 1% of the total BSA. Body regions are assigned a specific number of handprints with associated percentages (Head and neck = 10% \[10 handprints\], upper extremities = 20% \[20 handprints\], trunk (including axillae and groin) = 30% \[30 handprints\], lower extremities, including buttocks, = 40% \[40 handprints\]). Estimates of the percent involvement of each body region will be multiplied by the fraction of total body area to obtain the total %BSA involved by region and overall.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks.

Severity Index (EASI) score from Baseline to Week 8 Description: The EASI is a scoring system that takes into account the overall severity of disease based on lesion severity and the extent of percent body surface area affected with atopic dermatitis. The EASI is a composite score ranging from 0 -72 that takes into account the degree of erythema, edema/papulation, excoriation, and lichenification (each scored from 0 to 3 separately) for each of four body regions, with adjustment for the percent body surface area involved for each body region relative to the whole body. A higher EASI score represents more severe disease.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks

TEAEs are AEs that started on or after the first dose of study medication.

Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks

TEAEs are AEs that started on or after the first dose of study medication.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks .

TEAEs are AEs that started on or after the first dose of study medication.

Time frame: Baseline to the end of the Open-Label Period, up to 56 weeks.

TEAEs are AEs that started on or after the first dose of study medication.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

Time frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

Time frame: Baseline to last planned visit in the Double-Blind Period, up to 8 weeks

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

Time frame: Beginning of Open-Label to the end of the Open-Label Period, up to 48 weeks.

The LTS measures the presence and overall degree of irritation at the application site(s) using a 5-point scale, where 0 indicates no irritation and 4 very severe irritation.

A Randomized, Double-Blind, Vehicle-Controlled (Period 1) and Open-Label (Period 2) Phase 3 Study to Investigate the Safety and Efficacy of Tapinarof Cream, 1% in Pediatric Participants Ages 3 Months to < 24 Months With Atopic Dermatitis