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



Status:Active, not recruiting
Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - Any
Updated:11/30/2018
Start Date:December 14, 2017
End Date:December 15, 2019

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A Randomized, Double-blind, Vehicle-controlled Multicenter Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of ATI-50002 Topical Solution Administered Twice-Daily for 28 Days in Adult Subjects With AU and AT

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.

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. Concentrations of ATI-50002 in the blood and skin will be assessed after 28
days of treatment with ATI-50002 Topical Solution.

Inclusion Criteria:

- 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 Criteria:

- 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.
We found this trial at
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New York, New York 10155
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New York, NY
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