Eskata (hydrogen peroxide)

Company:                                 Aclaris Therapeutics

Approval Status:                    Approved December 2017

Specific Treatments:          seborrheic keratoses

Therapeutic Areas               Dermatology

 

General Information

Eskata is a high-concentration (40%) hydrogen peroxide-based topical solution.

Eskata is specifically indicated for the treatment of seborrheic keratoses that are raised.

Eskata is supplied as a solution for topical administration. During a single in-office treatment session, Eskata should be applied to seborrheic keratosis lesions 4 times, approximately 1 minute apart. The unit dose applicator should be discarded after one use. If the treated lesions have not completely cleared approximately 3 weeks after treatment, another treatment may be administered following the same procedure.

Clinical Results

FDA Approval

The FDA approval of Eskata was based on two pivotal Phase III trials (SEBK-301 and SEBK-302) that demonstrated the safety and efficacy of Eskata for the treatment of raised SKs. The trials enrolled 937 patients in total and were conducted at 34 centers in the United States. Overall, results from the combined trials showed 51.3% of lesions treated with Eskata were assessed as clear or near clear (PLA<1) at trial completion versus 7.3% of lesions in the placebo group. Notably, 65.3% of lesions on the face treated with Eskata were assessed as clear or near clear at trial completion versus 10.5% of lesions in the placebo group. The primary endpoint of both trials was the percentage of patients treated with Eskata who achieved clearance (PLA=0) of all four target SK lesions. In the SEBK-301 trial, 4.0% of patients treated with Eskata achieved clearance of all four target SK lesions (p<0.002); in the SEBK-302 trial, 7.8% of treated patients achieved clearance of all four target SK lesions (p<0.0001). None of the patients administered placebo achieved clearance of all four target SK lesions in either trial. In the SEBK-301 trial, 13.5% of patients treated with Eskata achieved clearance of at least three of the four target SK lesions (p<0.0001); in the SEBK-302 trial, 23.0% of treated patients achieved clearance of at least three of the four target SK lesions (p<0.0001).

Side Effects

Adverse effects associated with the use of Eskata may include, but are not limited to the following:

  • erythema
  • stinging
  • edema
  • scaling
  • crusting
  • pruritus

Mechanism of Action

Eskata is a high-concentration (40%) hydrogen peroxide-based topical solution designed for in-office application by a healthcare provider. It is a targeted treatment applied directly to the raised SK using a pen-like applicator. The mechanism of action of Eskata for the treatment of seborrheic keratosis is unknown.

Additional Information

For additional information regarding seborrheic keratosis or Eskata, please visit https://www.eskatahcp.com/#home