US company startrdet a clinical trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Arcutis Biotherapeutics, Inc is starting a new clinical trial of Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis.

The clinical trial started in January 27, 2021 and will continue throughout November 2022.

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).

Among the inclusion criteria are:

  • Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
  • Males and females, ages 6 years and older at time of signing Informed Consent (Screening).
  • Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
  • Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.

The contacts and locations are the Arcutis Clinical Site 05, San Diego, California, United States; Arcutis Clinical Site 06, San Francisco, California, United States; Arcutis Clinical Site 04, Jacksonville, Florida, United States; Arcutis Clinical Site 01, Tampa, Florida, United States; Arcutis Clinical Site 02, Indianapolis, Indiana, United States; Arcutis Clinical Site 03, Louisville, Kentucky, United States.

For more details: https://ichgcp.net/clinical-trials-registry/NCT04773587

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