Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Keratosis, Seborrheic

Skin Diseases

Precancerous Conditions

Pharmaceutical Solutions

All Drugs and Chemicals

A-101

Brian Beger, BS

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.

The main objective of this study is to evaluate the dose-response relationship of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied to seborrheic Keratosis (SK) target lesions on the face. A further objective is to evaluate the safety and efficacy of 2 concentrations of A-101 Solution and its matching A-101 Solution Vehicle when applied topically up to 2 times to SK target lesions on the face.

Study of A-101 for the Treatment of Seborrheic Keratosis

A Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Dose-Response Profile of A-101 Topical Solution in Subjects With Seborrheic Keratosis of the Face

The primary effectiveness analysis was a comparison between each A-101 group and the vehicle group based on the percentage with target lesions judged to be clear on the PLA (PLA = 0) at Visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better.

A secondary efficacy analysis was the mean change from baseline PLA Score at visit 8. The three arms of the study are A-101 40% Topical Solution, A-101 32.5% Topical Solution, and A-101 0% Topical Solution (vehicle). The Physician's Lesion Analysis ( PLA) is a 4 point scale from 0 to 3, with 0 being lesion clear and 3 being the most severe lesion. A larger proportion of subjects with a PLA =0 is better. A lower (more negative) mean change is a better outcome.

Aclaris Therapeutics, Inc.

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation subject administered a study medication(s) and that did not necessarily have a causal relationship with the study medication.

Safety summaries by study medication group will include listings by study medication of adverse events incidences within each MedDRA System Organ Class, and changes from pre-application values in vital signs.

A-101 40% Topical Solution

A-101: Topical Solution

A-101 40%

A-101 32.5% Topical Solution

A-101: Topical Solution

A-101 32.5%

A-101 0% Topical Solution (vehicle)

A-101: Topical Solution

A-101 Vehicle Topical Solution

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

Judith Schnyder, Senior Director of Clinical Operations

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

The primary efficacy analysis of mean change from baseline to Visit 8 PLA was performed using analysis of covariance (ANCOVA) with baseline PLA as the covariate. Comparisons between vehicle and each A-101 group were performed within the model using least-squares means and the common error term.

Spots Global Cancer Trial Database for Study of A-101 for the Treatment of Seborrheic Keratosis

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