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A Study of ATI-50002 Topical Solution for the Treatment of Alopecia Areata

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ClinicalTrials.gov Identifier: NCT03354637
Recruitment Status : Recruiting
First Posted : November 28, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Brief Summary:

Primary:

• To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA)

Secondary:

• To evaluate key clinical outcome assessments


Condition or disease Intervention/treatment Phase
Alopecia Areata Drug: ATI-50002 high dose Drug: ATI-50002 low dose Drug: Placebo Phase 2

Detailed Description:

Primary:

• To assess safety, tolerability and efficacy of 2 dose strengths of ATI-50002 Topical Solution, compared to vehicle in subjects with alopecia areata (AA)

Secondary:

• To evaluate key clinical outcome assessments


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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, Tolerability and Efficacy of ATI-50002 Topical Solution Administered for 3 Months in Adult Subjects With Alopecia Areata
Actual Study Start Date : December 14, 2017
Estimated Primary Completion Date : January 18, 2019
Estimated Study Completion Date : January 18, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ATI-50002 high dose Topical Solution
High dose active
Drug: ATI-50002 high dose
Topical solution

Active Comparator: ATI-50002 low dose Topical Solution
low dose active
Drug: ATI-50002 low dose
Topical solution

Placebo Comparator: Vehicle Topical Solution
placebo
Drug: Placebo
Topical solution




Primary Outcome Measures :
  1. Amount of hair growth in participants will be measured using measurements such as the severity of alopecia tool. [ Time Frame: 12 weeks ]


Information from the National Library of Medicine

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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:

  1. Have a clinical diagnosis of alopecia areata (AA) defined as no current areas of active regrowth, with up to mild (less than 10%) incremental scalp hair loss over the previous 6 months based on subject history.
  2. Have a Severity of Alopecia Tool (SALT) score of at least 30% up to 95% total scalp hair loss determined by the study investigator at baseline.
  3. Have a duration of the current episode of scalp hair loss of a minimum of 6 months and a maximum of seven years.
  4. If a woman of childbearing potential (WOCBP), must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2) and agree to: use a highly effective method of birth control for the duration of the study; not be planning a pregnancy during the study duration and use contraception for 30 days after last application of study medication.

Exclusion Criteria:

  1. Females who are nursing, pregnant, or planning to become pregnant for the duration of the study and up to 30 days after the last application of study medication.
  2. Diffuse alopecia areata or a history of an atypical pattern of AA (e.g., ophiasis, sisaihpo).
  3. Concomitant hair loss disorder (by history or physical exam) such as androgenetic alopecia or scarring alopecia (e.g., cicatricial alopecia, frontal fibrosing alopecia, etc.).
  4. 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.
  5. Active scalp trauma or other condition affecting the scalp that, in the investigator's opinion, may affect the course of AA or interfere with the study conduct or evaluations.
  6. 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): NCT03354637


Contacts
Contact: Susan Moran, MSN 484-329-2129 smoran@aclaristx.com

Locations
United States, California
Aclaris Investigator Site Recruiting
Encinitas, California, United States, 92024
Aclaris Investigator Site Recruiting
Laguna Hills, California, United States, 92653
Aclaris Investigator Site Recruiting
Redwood City, California, United States, 94063
United States, District of Columbia
Aclaris Investigator Site Recruiting
Washington, District of Columbia, United States, 20037
United States, Florida
Aclaris Investigator Site Recruiting
Boynton Beach, Florida, United States, 33472
Aclaris Investigator Site Recruiting
Miami, Florida, United States, 33136
United States, Massachusetts
Aclaris Investigator Site Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Aclaris Investigator Site Recruiting
Clinton Township, Michigan, United States, 48038
Aclaris Investigator Site Recruiting
Warren, Michigan, United States, 48088
United States, Minnesota
Aclaris Investigator Site Recruiting
Fridley, Minnesota, United States, 55432
Aclaris Investigator Site Recruiting
Minneapolis, Minnesota, United States, 55455
United States, Nebraska
Aclaris Investigator Site Recruiting
Omaha, Nebraska, United States, 68144
United States, New York
Aclaris Investigator Site Recruiting
New York, New York, United States, 10155
United States, North Carolina
Aclaris Investigator Site Recruiting
Durham, North Carolina, United States, 27710
Aclaris Investigator Site Recruiting
Winston-Salem, North Carolina, United States, 27104
United States, Oregon
Aclaris Investigator Site Recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Aclaris Investigator Site Recruiting
Fort Washington, Pennsylvania, United States, 19034
United States, Tennessee
Aclaris Investigator Site Recruiting
Knoxville, Tennessee, United States, 37922
Aclaris Investigator Site Recruiting
Nashville, Tennessee, United States, 37215
United States, Texas
Aclaris Investigator Site Recruiting
Austin, Texas, United States, 78745
Aclaris Investigator Site Recruiting
Austin, Texas, United States, 78759
Aclaris Investigator Site Not yet recruiting
San Antonio, Texas, United States, 78229
Aclaris Investigator Site Recruiting
San Antonio, Texas, United States, 78745
Sponsors and Collaborators
Aclaris Therapeutics, Inc.

Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03354637     History of Changes
Other Study ID Numbers: ATI-50002-AA-201
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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