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A Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495817
Recruitment Status : Active, not recruiting
First Posted : April 12, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Aclaris Therapeutics, Inc.

Study Description
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Brief Summary:
Open label study to assess safety, tolerability, and efficacy of ATI-50002 in male and female subjects with androgenetic alopecia.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Drug: ATI-50002 Phase 2

Detailed Description:
This is an open-label study designed to evaluate the safety and efficacy of ATI-50002 Topical Solution in male and female subjects with androgenetic alopecia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Safety, Tolerability, and Efficacy Study in Male and Female Subjects With Androgenetic Alopecia Treated With ATI-50002 Topical Solution
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Open Label ATI-50002 Topical Solution Drug: ATI-50002
ATI-50002 Topical Solution


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change from Baseline in Target Area Hair Count (TAHC) [ Time Frame: Week 26 ]

Secondary Outcome Measures :
  1. Change from baseline in cumulative Target Area Hair Width [ Time Frame: Week 26 ]
  2. Development of new hair growth using a seven-point rating scale [ Time Frame: Week 26 ]
    Subjects and Investigators will use a 7 point rating scale to assess hair growth following treatment with study medication. A score of +3 corresponds to significant hair growth and a score of -3 corresponds to lack of hair growth.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Male subjects and non-pregnant, non-nursing female subjects 18-50 years of age with a clinical diagnosis of androgenetic alopecia.

Subjects willing to agree to have a small circle of hair clipped to approx. 1mm in length on their balding spot.

Subjects willing to agree to have a permanent dot tattoo applied to their scalp to mark the center of the identified target area.

Subjects must agree to maintain the same hair style and hair care regimen during the study.

Exclusion Criteria:

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.

Clinical diagnosis of alopecia areata or other non AGA forms of alopecia. Scalp hair loss on the treatment area, due to disease, injury or medical therapy.

Active skin disease of 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 or efficacy or safety. -

Contacts and Locations
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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): NCT03495817


Locations
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United States, Colorado
Aclaris Investigational Site
Denver, Colorado, United States, 80210
United States, Oregon
Aclaris Investigational Site
Portland, Oregon, United States, 97210
United States, Texas
Aclaris Investigational Site
Austin, Texas, United States, 78759
Sponsors and Collaborators
Aclaris Therapeutics, Inc.
Investigators
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Study Chair: Stuart Shanler, MD Aclaris Therapeutics, Inc.
More Information
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Responsible Party: Aclaris Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03495817    
Other Study ID Numbers: ATI-50002-AGA-201
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
 Skin Diseases
Pathological Conditions, Anatomical
Pharmaceutical Solutions