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A phase 3 efficacy and safety study of tapinarof for the treatment of moderate to severe atopic dermatitis in children and adults

Clinical Trial Details

Atopic dermatitis (AD) is a long-lasting inflammatory skin disease. It can cause areas of dry, thickened, raised, red skin that may crust and/or ooze. Although there is currently no cure, treatments may help control symptoms. Topical treatments aim to reduce inflammation and itching. Several options are available, but there is a need for a safe and effective topical treatment that can be applied to a large area without restrictions on how long it can be used.

This study will evaluate the safety and efficacy of tapinarof cream, 1%, a new, nonsteroidal, anti-inflammatory agent for the topical treatment for AD. Stabilizing the disease and reducing the number and severity of atopic dermatitis flares are the primary goals of treatment.

Tapinarof cream, 1% is approved by the U.S. Food and Drug Administration (FDA) for the treatment of plaque psoriasis, but it is not yet approved for the treatment of atopic dermatitis.

Participants will be randomized at a 2:1 ratio into one of two treatment groups. The first group will apply tapinarof cream, 1% and the second group will apply vehicle cream, which contains no active ingredients.

Study participation will last for 8 weeks, and participants will apply cream once daily for the duration of the study.

Participants will be expected to come into the office for 7 study visits and compensation of $50 is available for each completed visit.

Key Eligibility: 
  1. Males and females between the age of 2-17
  2. A clinical diagnosis of atopic dermatitis covering between 5% and 35% of the body  
  3. Atopic dermatitis present for at least 6 months for ages 6 years old and above or 3 months for ages 2 to 5 years old

Detailed eligibility reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan


Angelica Nazarian
(646) 962-2090

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:




DMVT 505-3101


Open to Enrollment

Age Group