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

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ClinicalTrials.gov Identifier: NCT03315689
Recruitment Status : Active, not recruiting
First Posted : October 20, 2017
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Alopecia Universalis (AU) Alopecia Totalis (AT) Drug: Vehicle Drug: ATI-50002 Phase 2

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Vehicle
Vehicle
Drug: Vehicle
Vehicle Topical Solution

Experimental: Active
ATI-50002 Topical Solution
Drug: ATI-50002
ATI-50002 Topical Solution




Primary Outcome Measures :
  1. Peak Plasma Concentration (Cmax) of ATI-50002 [ Time Frame: 24 hours post dose on Day 1 and Day 28 ]

Secondary Outcome Measures :
  1. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 0, 1, 2, 4, 8, and 24 hours post-dose ]
  2. Concentration of ATI-50002 in the skin [ Time Frame: 24 hours post-dose ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315689


Locations
United States, New York
Aclaris Investigational Site
New York, New York, United States, 10032
Aclaris Investigational Site
New York, New York, United States, 10075
Sponsors and Collaborators
Aclaris Therapeutics, Inc.

Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03315689     History of Changes
Other Study ID Numbers: ATI-50002-AA-202
First Posted: October 20, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions