Phase 3 N=450 Randomized Double-blind Treatment

A Study of A-101 Solution 40% in Subjects With Seborrheic Keratosis.

Seborrheic Keratosis

Bottom Line

View on ClinicalTrials.gov: NCT02667236 ↗

Enrolled (actual)

450

Serious AEs

2.2%

Results posted

Nov 2017

Primary outcome: Primary: Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment — 9; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: A-101 Solution (Drug); Vehicle Solution (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Aclaris Therapeutics, Inc.
Primary completion: Oct 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects With Target Lesion Clearance as Assessed by the Physician Lesion Assessment	9; 0	—
SECONDARY Proportion of Subjects With 3 of 4 Target Lesion Clearance	30; 0	—

Summary

This is a randomized, double-blind, vehicle-controlled, parallel group study of A-101 Solution 40% compared with Vehicle Solution.

Eligibility Criteria

Inclusion Criteria

Subject is at least 18 years of age
Clinical diagnosis of stable clinically typical seborrheic keratosis
Subject has 4 appropriate seborrheic keratosis Target Lesions on the trunk, extremities and face that each are eligible for treatment as defined below:
Have a clinically typical appearance
Have a PLA of 2 or greater and be a discrete lesion
Not be covered with hair which, in the investigator's opinion, would interfere with the study medication treatment or the study evaluations
Not be in an intertriginous fold
Not be on the eyelids
Not be within 5mm of the orbital rim
Not be pedunculated
If the subject is a woman of childbearing potential, she has a negative urine pregnancy test and agrees to use an active method of birth control 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 any 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.

Exclusion Criteria

Subject has clinically atypical and - or rapidly growing seborrheic keratosis lesions
Subject has presence of multiple eruptive seborrheic keratosis lesions (Sign of Lesser -Trelat)
Subject has a current systemic malignancy
Subject has used any of the following systemic therapies within the specified period prior to enrollment:
Retinoids; 180 days
Glucocortico-steroids;
Anti-metabolites (e.g., methotrexate);
Subject has used any of the following topical therapies within the specified period or in a proximity to any Target Lesion, that in the investigator's opinion interferes with the study medication treatment or the study assessments:
LASER, light or other energy based therapy (e.g., intense pulsed light, photo-dynamic therapy;
Liquid nitrogen, electrodesiccation, curettage, imiquimod, 5-flurouracil, or ingenol mebutate;
Retinoids;
Microdermabrasion or superficial chemical peels;
Glucocortico-steroids or antibiotics
Subject currently has or has had any of the following within the specified period or in a proximity to any Target Lesion that, in the investigator's opinion, interferes with the study medication treatment or the study assessments:
A cutaneous malignancy;
A sunburn; currently
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) that, in the opinion of the investigator, 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 enrollment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02667236). 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.