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Phase 2 N=1 Treatment

Open Label Study of ATI-50002 Topical Solution Administered to Adult Subjects With Eyebrow Loss Due to Alopecia Areata

Alopecia Areata · Alopecia Totalis · Alopecia Universalis

Enrolled (actual)
1
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Clinician's Eyebrow Assessment — 0 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
ATI-50002 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Aclaris Therapeutics, Inc.
Primary completion
Nov 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Clinician's Eyebrow Assessment
SECONDARY
Subject's Eyebrow Assessment

Summary

The main objective of this study is to assess the safety, tolerability and efficacy of ATI-50002 Topical Solution in subjects with unilateral or bilateral loss of eyebrow hair due to alopecia areata (AA), alopecia universalis (AU) or alopecia totalis (AT).

Eligibility Criteria

Inclusion Criteria

  • Subject is at least 18 years of age.
  • Subject has, based on a subject history and clinical examination, a clinical diagnosis of AA, AU or AT with no eyebrow hair in the affected area(s) and no eyebrow regrowth over the previous 6 months. Affected area is defined as the area(s) of eyebrow hair loss identified at Baseline.
  • Subject has a Clinician Eyebrow Assessment score of 0 for at least one eyebrow.
  • Subject has a Subject Eyebrow Assessment score of 0 for at least one eyebrow.
  • Subject has a duration of the current episode of AA, AU or AT with unilateral or bilateral loss of eyebrow hairs (with at least one distinct patch of >30% loss of eyebrow hair) for at least 6 months and no more than seven years prior to Visit 1.
  • Subjects who are Women of Childbearing Potential (WOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree to use a highly effective method of birth control for the duration of the study and for 30 days after last study medication application.
  • Subject is non-pregnant and non-lactating and not planning a pregnancy during the duration of the study and for 30 days after the last study medication application.
  • Subject is in good general health and free of any known disease state or physical condition which, in the opinion of the investigator, would interfere with the study requirements or put the subject at undue risk by study participation.
  • Subject is willing and able to follow all study instructions and to attend all study visits.
  • Subjects taking hormonal replacement therapy must have been on the same dose for at least 6 months prior to Visit 1 and must agree to maintain the same dose for the duration of the study and for 90 days after the last study medication application.
  • Subjects taking thyroid replacement therapy must have been on the same dose for at least 6 months prior to Visit 1 and must agree to maintain the same dose for the duration of the study.
  • Subject agrees to refrain from any eyebrow removal (e.g.¸ plucking, threading, etc.) for the duration of the study.
  • Subject agrees to refrain from any cosmetic surgery (e.g., piercing, tattooing, etc.), on the treatment areas, for the duration of the study.
  • Subject can comprehend and is willing to sign an Informed Consent Form (ICF).
  • Sexually active male subjects must agree to use a barrier method of contraception from the first application of study medication to at least 30 days after the last application of study medication

Exclusion Criteria

  • Subject has, in the opinion of the investigator, permanent eyebrow loss attributed to causes other than AA, AU or AT such as overgrooming, or scarring hair loss.
  • Subject currently has, or has a history of, skin disease in the eyebrow area (e.g., psoriasis, seborrheic dermatitis, etc.) that, in the opinion of the investigator, would interfere with the study medication application or study assessments.
  • Subject currently has, or has a history of, severe, progressive or uncontrolled autoimmune, metabolic, endocrinologic, renal, hepatic, gastrointestinal, pulmonary, cardiovascular, genitourinary (i.e., renal disease), hematological disease, neurologic or cerebral disorders, infectious disease or coagulation disorders that, in the opinion of the investigator, put the subject at undue risk by study participation.
  • Subject currently has, or has a history of, proven or suspected systemic or cutaneous malignancy and /or lymphoproliferative disease, other than a history of adequately treated, well healed and completely cleared non-melanoma skin cancers (e.g. basal or squamous cell carcinoma) treated successfully at least one year prior to Visit 1.
  • Subject currently has evidence of active or latent bacterial infection, including tuberculosis, or viral infections at the time of enrollment or a history of incompletely treated or untreated tuberculosis. Subjects who have completed therapy f
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03551821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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