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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-14

Study Completion Date

2019-06-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alopecia Universalis (AU) Alopecia Totalis (AT)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Vehicle

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Vehicle Topical Solution

Active

ATI-50002 Topical Solution

Group Type EXPERIMENTAL

ATI-50002

Intervention Type DRUG

ATI-50002 Topical Solution

Interventions

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Vehicle

Vehicle Topical Solution

Intervention Type DRUG

ATI-50002

ATI-50002 Topical Solution

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No