STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AN INVESTIGATIONAL DRUG IN ADULT PATIENTS WITH MODERATE TO SEVERE ALOPECIA AREATA

What we are studying

This is a double-blind, randomized, placebo-controlled, parallel dose-comparison, multicenter study to evaluate the safety and efficacy of an investigational drug in adult patients with chronic, moderate to severe alopecia areata. Patients will be between 18 and 65 years of age and experiencing an episode of alopecia areata lasting at least 6 months and not exceeding 10 years, with at least 50% hair loss as measured by the SALT at Screening and Baseline, and are not concurrently being treated for alopecia areata or with other treatments that might affect hair regrowth. The study is divided into 4 periods: Screening, Treatment, Dose-Adjustment, and Post-Treatment Safety Follow-Up. The Screening Period may last up to 21 days prior to initiation of study drug. The Treatment Period is the initial 24-week, double-blind, placebo-controlled period to define primary efficacy for the study. The subsequent Dose-Adjustment Period is a 28-week, double-blind treatment period where patients tolerating treatment may adjust at Week 24 as needed to a potentially more efficacious dose, and placebo patients will begin active treatment. The Post-Treatment Safety Follow-up Period is the final 4 weeks of the study to assess safety upon active treatment completion.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
  • Not Hispanic or Latino
  • Ages 18 - 65

Eligibility Criteria

  • - No history or presence of hair transplants -Unwilling to maintain a consistent hair style
  • Including shampoo and hair products (including hair dye
  • Process
  • And timing to hair appointments)
  • And to refrain from weaves or extensions throughout the course of the study
  • Or shaving of scalp hair for 2 weeks preceding a SALT assessment. -Use of adhesive wigs
  • Other than banded perimeter wigs
  • During the study. -Donation of blood within a month of first dose of study drug or at any point throughout the study and for 30 days after last dose of study medication.

What is involved

  • Physical exams
  • Height and weight assessment
  • Pregnancy test
  • TB test
  • Blood draws
  • ECG's
  • Photographs
  • Subject questionnaires

Compensation

$30/Visit for a total of $600 if you complete every visit

Contact Information

Study Coordinator
Dermatology Clinical Studies
Email
Dermadvertising@wakehealth.edu
Phone
336-716-3775
Principal Investigator
Amy McMichael, MD

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.