Study of A-101 for the Treatment of Seborrheic Keratosis

Completed · Phase 2

Conditions studied: Seborrheic Keratosis

In brief

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.

Key facts

Study ID: NCT02260180
Run by: Aclaris Therapeutics, Inc.
People needed: 119
Starts: 2014-10-01
Expected to finish: 2015-03-01
Last updated by the study team: 2020-12-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Have a clinically typical appearance
Be treatment naïve
Have a Physician's Lesion Assessment (PLA) of ≥2 (Section 6.1.2)
Have a longest axis that is ≥7mm and ≤15mm (Section 5.4)
Have a longest dimension perpendicular to the longest axis that is ≥7mm and ≤15mm (Section 5.4)
Have a thickness that is ≤2mm
Be a discrete lesion
Be, when centered in the area outlined by the provided 3cm diameter circular template, the only seborrheic keratosis lesion present
Not be on the eyelids
Not be within 5mm of the orbital rim
Not be covered with hair which, in the investigator's opinion, would interfere with the study medication application or the study evaluations (NB: the study medication may bleach hair)
Not be in an intertriginous fold
Not be pedunculated.
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
Subject is able to comprehend and willing to sign an Informed Consent Form (ICF).

You may not qualify if…

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:
Retinoids; 180 days
Glucocortico-steroids; 28 days
Anti-metabolites (e.g., methotrexate); 28 days
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:
LASER, light (e.g., intense pulsed light (IPL), photo-dynamic therapy(PDT)) or other energy based therapy; 180 days
Retinoids; 28 days
Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-fluorouracil, or ingenol mebutate; 60 days
Glucocortico-steroids or antibiotics; 14 days
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 :
A cutaneous malignancy; 180 days
Experienced a sunburn; 28 days
A pre-malignancy (e.g., actinic keratosis); currently
Body art (e.g., tattoos, piercing, etc.); currently
Excessive tan; currently
Subject has a history of sensitivity to any of the ingredients in the study medications
Subject has any current skin disease (e.g., psoriasis, atopic dermatitis, eczema, sun damage, etc.), or condition (e.g., sunburn, excessive hair, open wounds) which, in the investigator's opinion, might put the subject at undue risk by study participation or interfere with the study conduct or evaluations
Subject has participated in an investigational drug trial in which administration of an investigational study medication occurred within 30 days prior to Visit 1.

Where it is running

Oregon Medical Research Center — Portland, Oregon, United States
Philadelphia Institute of Dermatology — Fort Washington, Pennsylvania, United States
DermReseach, Inc. — Austin, Texas, United States
The Education & Research Foundation, Inc. — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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