MALVERN, PA, USA I January 19, 2016 I Aclaris Therapeutics, Inc. (ACRS), today announced the initiation of two Phase 3 clinical trials to evaluate A-101 Topical Solution for the treatment of seborrheic keratosis (SK).
The two Phase 3 clinical trials will evaluate the safety and efficacy of A-101 Topical Solution compared with a vehicle solution (placebo). Approximately 800 subjects will be randomized in these multi-center, double-blinded, vehicle-controlled, clinical trials, which are being conducted at 34 investigational centers within the United States.
“The initiation of the Phase 3 program for A-101 Topical Solution is an important milestone in our development program and follows the positive Phase 2 clinical results and an End-of-Phase 2 meeting with the FDA,” said Christopher Powala, Chief Operating Officer of Aclaris. “Our goal is to offer a new treatment option for patients and physicians to treat SK lesions, a condition for which there are currently no FDA-approved drugs.”
About Seborrheic Keratosis
SK lesions are one of the most common skin tumors, affecting over 83 million people in the United States. SK lesions are often pigmented, have a waxy, scaly, slightly elevated appearance and typically multiple growths are present. While benign, these lesions are often cosmetically disturbing, may become symptomatic (irritated, pruritic [itchy], painful) or may be confused with more serious skin lesions. Currently, SK lesions are treated by cryotherapy, electrosurgery, curettage, or surgical removal. Each of these methods may be painful or can result in pigmentary changes or scarring at the treatment site.
About Aclaris
Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. Aclaris Therapeutics, Inc. is based in Malvern, Pennsylvania and more information can be found by visiting the company’s website at www.aclaristx.com.
SOURCE: Aclaris
Post Views: 100
MALVERN, PA, USA I January 19, 2016 I Aclaris Therapeutics, Inc. (ACRS), today announced the initiation of two Phase 3 clinical trials to evaluate A-101 Topical Solution for the treatment of seborrheic keratosis (SK).
The two Phase 3 clinical trials will evaluate the safety and efficacy of A-101 Topical Solution compared with a vehicle solution (placebo). Approximately 800 subjects will be randomized in these multi-center, double-blinded, vehicle-controlled, clinical trials, which are being conducted at 34 investigational centers within the United States.
“The initiation of the Phase 3 program for A-101 Topical Solution is an important milestone in our development program and follows the positive Phase 2 clinical results and an End-of-Phase 2 meeting with the FDA,” said Christopher Powala, Chief Operating Officer of Aclaris. “Our goal is to offer a new treatment option for patients and physicians to treat SK lesions, a condition for which there are currently no FDA-approved drugs.”
About Seborrheic Keratosis
SK lesions are one of the most common skin tumors, affecting over 83 million people in the United States. SK lesions are often pigmented, have a waxy, scaly, slightly elevated appearance and typically multiple growths are present. While benign, these lesions are often cosmetically disturbing, may become symptomatic (irritated, pruritic [itchy], painful) or may be confused with more serious skin lesions. Currently, SK lesions are treated by cryotherapy, electrosurgery, curettage, or surgical removal. Each of these methods may be painful or can result in pigmentary changes or scarring at the treatment site.
About Aclaris
Aclaris Therapeutics, Inc. is a clinical-stage specialty pharmaceutical company focused on identifying, developing, and commercializing innovative and differentiated drugs to address significant unmet needs in dermatology. Aclaris Therapeutics, Inc. is based in Malvern, Pennsylvania and more information can be found by visiting the company’s website at www.aclaristx.com.
SOURCE: Aclaris
Post Views: 100
