Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)

Last Updated:
04/24/2018
Status:
Active/Fully Enrolled
Country:
United States
Eligibility:
Age 18+; diagnosed with alopecia universalis or alopecia totalis
Drug:
ATI-50002
Administration:
Topical
Sponsor: 
Aclaris Therapeutics, Inc.

A clinical research study is currently looking for adults with alopecia universalis (total loss of all scalp and body hair including eyebrows, eyelashes, and intranasal hair) or alopecia totalis (total scalp hair loss) to participate in a study of a topical investigational medication.

The main purpose of this study is to evaluate the safety and tolerability of a topical investigational medication, ATI-50002, or placebo when applied to your scalp over 4 weeks.  During this time, the study will also try to find out how your scalp absorbs, distributes, and gets rid of ATI-50002 or placebo and what effect it has on your scalp’s skin cells.  After the first 4 weeks, you will have the option to continue applications to your scalp for up to an additional 24 weeks using only ATI-50002 (no placebo will be used).  During this second period, the study will assess the effectiveness and subject satisfaction following applications with only ATI-50002 topical solution.

You may qualify to participate if you:

  • Are at least 18 years old
  • Have areas of hair loss on the scalp due to Alopecia Universalis (AU) or Alopecia Totalis (AT)
  • Have been experiencing the current episode of AU or AT for at least 6 months and no more than 7 years
  • Have greater than 95% total scalp hair loss
  • Are willing to stop any current prohibited treatments for your scalp hair loss
  • Are willing to have 5 scalp biopsies during the study
  • Are willing to attend regular study visits (up to 14 visits, 1-4 weeks apart) involving lab tests, electrocardiograms, questionnaires, and other study procedures for the duration of the study (up to 32 weeks)

For participants, all investigational medication, study-related tests and study-related doctor’s visits will be provided at no cost for the duration of the study. Participation is voluntary, and you may withdraw at any time participants may be reimbursed for reasonable travel expenses for study visits.

The Following Trials Sites May Be Contacted For More Information About Participation In The Study:

Sadick Research Group, LLC
New York City, NY
Contact: Krista Bohnert
Phone: 212-772-7242