CompletedPhase 2

Study of A-101 for the Treatment of Seborrheic Keratosis

United States119 participantsStarted 2014-10

Plain-language summary

The purpose of this study is to evaluate the safety and dose-response of 2 concentrations of A-101 versus a vehicle control in the treatment of seborrheic keratosis.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subject is at least 18 years of age
✓. Subject has a Fitzpatrick skin type of 1-4
✓. Subject has a clinical diagnosis of stable clinically typical seborrheic keratosis
✓. Subject has 1 appropriate seborrheic keratosis target lesion, as defined below (Section 5.4), on the face:
✓. If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an approved effective method of birth control (Section 8) for the duration of the study
✓. Subject is non-pregnant and non-lactating
✓. Subject is in good general health and free of any known disease state or physical condition which, in the investigator's opinion, might impair evaluation of the target lesion or which exposes the subject to an unacceptable risk by study participation
✓. Subject is willing and able to follow all study instructions and to attend all study visits

Exclusion criteria

✕. Subject has clinically atypical and/or rapidly growing seborrheic keratosis lesions
✕. Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Leser-Trelat)
✕. Subject has a current systemic malignancy
✕. Subject has a history of keloid formation or hypertrophic scarring
✕. Subject has used any of the following systemic therapies within the specified period prior to Visit 1:
✕. Subject has used any of the following topical therapies within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments:
✕. Subject currently has or has had any of the following within the specified period prior to Visit 1 on, or in a proximity to the target lesion, which in the investigator's opinion, interferes with the application of the study medication or the study assessments :
✕. Subject has a history of sensitivity to any of the ingredients in the study medications

What they're measuring

Percentage of PLA Responders With Target Lesion Clear (PLA = 0) in Each Arm at Visit 8.

Timeframe: Day 106

Trial details

NCT IDNCT02260180

SponsorAclaris Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-03

Results submitted2018-09-30

View on ClinicalTrials.gov More Seborrheic Keratosis trials