Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alop… (NCT03315689) | Clinical Trial Compass
CompletedPhase 2
Safety and Pharmacokinetic Study of ATI-50002 in Subjects With Alopecia Universalis (AU) and Alopecia Totalis (AT)
United States11 participantsStarted 2017-12-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
What they're measuring
1
Double Blind Period: ATI-50002 Levels in Scalp Biopsy (ng/g) - Pharmacodynamic (PD) Population at Day 2 and Day 29