Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
Completed · Phase 2
Conditions studied: Alopecia Universalis (AU), Alopecia Totalis (AT)
In brief
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.
Key facts
- Study ID
- NCT03315689
- Run by
- Aclaris Therapeutics, Inc.
- People needed
- 11
- Starts
- 2017-12-14
- Expected to finish
- 2019-06-20
- Last updated by the study team
- 2020-07-02
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Aclaris Investigational Site — New York, New York, United States
- Aclaris Investigational Site — New York, New York, United States
Full record on ClinicalTrials.gov
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