Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Keratosis, Seborrheic

Skin Diseases

Precancerous Conditions

Pharmaceutical Solutions

All Drugs and Chemicals

Low Dose Concentration of A-101 applied to one of 4 Target Lesions

A-101 25%

Mid Dose Concentration of A-101 applied to one of 4 Target Lesions

A-101 32.5%

High Dose Concentration A-101 applied to one of 4 Target Lesions

A-101 40%

Placebo applied to one of 4 Target Lesions

A-101 Vehicle

Janet Dubois, MD

Evaluate the safety, tolerability of A-101 when applied to seborrheic keratosis lesions on the back of subjects.

The main objective of this study is to evaluate the safety, effectiveness and tolerability of three concentrations of A-101 25%, 32.5%, and 40%, when applied to individual seborrheic keratosis target lesions on the back compared with a matching A-101 vehicle.

The three tests solutions and the placebo solution are each applied topically to 1 of 4 target lesions on the backs of each subject (determined by the randomization schedule). If needed a second treatment may be applied at Visit 5.

Study of Safety, Tolerability and Effectiveness of A-101 in Subjects With Seborrheic Keratosis

A Randomized, Double-Blind, Vehicle-Controlled, Within-Subject, Comparison Study of the Safety, Tolerability, And Effectiveness of A-101 Topical Solution in Subjects With Seborrheic Keratosis

Mean Change in Score on the Physician Lesion Assessment Scale (PLA) of each Target Lesion. The PLAS is a four point scale from 0-3 with 0 being clear and 3 being the worst lesion.

The primary effectiveness will consist of the mean change from Visit 2 to Visit 9 in PLA performed using Analysis of Covariance (ANCOVA) with Visit 2 PLAS as the covariate. Comparisons between vehicle and each active treatment group will be performed within the model using least-squares means and the common error term.

Subjects self assessment of the condition of their lesions based on a scale of Clear (Grade 0), Mild (Grade 1), Moderate (Grade 2), Severe (Grade 3).

Aclaris Therapeutics, Inc.

Low dose group

A-101 25%: Low Dose Concentration of A-101 applied to one of 4 Target Lesions

Mid Dose Group

A-101 32.5%: Mid Dose Concentration of A-101 applied to one of 4 Target Lesions

High Dose Group

A-101 40%: High Dose Concentration A-101 applied to one of 4 Target Lesions

Placebo group

A-101 Vehicle: Placebo applied to one of 4 Target Lesions

Subjects were required to have 4 Target Seborrheic Keratosis Lesions their back. Each lesion was treated with one of the four treatment interventions (A-101 Solution 25%, A-101, Solution 32.5%, A-101 Solution 40% and the A-101 Solution Vehicle) in a randomized fashion.

Entire Study Population

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Since each patient simultaneously participates in all four treatment groups only skin site related adverse events are reported by treatment group. Systemic adverse events are reported in all treatment groups the same.

Christopher Powala, Chief Operating Officer

A total of 35 subjects were enrolled with 34 subjects in the analysis population. Each target lesion on a subject was treated with one of the 4 study medications in a random fashion.

Spots Global Cancer Trial Database for seborrheic keratosis (sk)