Status:
COMPLETED
Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
Lead Sponsor:
Aclaris Therapeutics, Inc.
Conditions:
Alopecia Universalis (AU)
Alopecia Totalis (AT)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary objective is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution compared to vehicle in subjects with AU and AT.
Detailed Description
This study is designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ATI-50002 Topical Solution in patients with Alopecia Universalis and Alopecia Totalis. Concentrati...
Eligibility Criteria
Inclusion
- Able to comprehend and willing to sign an Informed Consent Form (ICF).
- Male or non-pregnant, non-nursing female ≥18 years old at the time of informed consent.
- Have a clinical diagnosis of stable, clinically typical, AU or AT.
- Have a duration of the current episode of AU or AT for a minimum of 6 months and a maximum of seven years.
- Be willing and able to follow all study instructions and to attend all study visits.
Exclusion
- Females who are nursing, pregnant, or planning to become pregnant for the duration of the study including 30 days after the last application of study medication.
- Patchy alopecia areata, diffuse alopecia areata or a history of an atypical pattern of Alopecia Areata (AA) (e.g., ophiasis, sisaihpo).
- Active skin disease on the scalp (such as psoriasis or seborrheic dermatitis) or a history of skin disease on the scalp that in the opinion of the investigator would interfere with the study assessments of efficacy or safety.
- Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AU or AT or interfere with the study conduct or evaluations.
- The presence of a permanent or difficult to remove hairpiece or wig that will, in the opinion of the investigator, interfere with study assessments if not removed at each visit.
Key Trial Info
Start Date :
December 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2019
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03315689
Start Date
December 14 2017
End Date
June 20 2019
Last Update
July 2 2020
Active Locations (2)
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1
Aclaris Investigational Site
New York, New York, United States, 10032
2
Aclaris Investigational Site
New York, New York, United States, 10075