Study design2

  • Two identical, multicenter, randomized, double-blind, vehicle-controlled US trials

  • Subjects with 4 clinically typical SKs that are raised were randomized to treatment with either ESKATA or vehicle

  • Each subject had at least 1 SK on the face and 1 on the trunk or extremities

  • Subjects ranged from 42 to 91 years of age, 58% were female, and 98% were Caucasian

  • Nearly all patients received 2 treatments

Physician’s Lesion Assessment (PLA) scale

A novel, validated assessment tool used in 
ESKATA pivotal trials 1

Efficacy data

In pivotal trials, ESKATA demonstrated efficacy in clearing raised SKs

In pivotal trials, efficacy was assessed based
on reaching clear status, defined as "no visible SK"

Clear: PLA = 0

Baseline

Post-treatment

PLA: 3

PLA: 0

PLA: 3

PLA: 0

Photos have not been retouched. Individual results may vary. Post-treatment photos taken at day 106.

Not clear: PLA ≥ 1

Baseline

Post-treatment

PLA: 3

PLA: 1

PLA: 3

PLA: 1

Some subjects experience changes in raised SKs without achieving clearance.

For more trial images, browse the Visual Library

Safety data

Percentage of subjects with local skin reactions by severity (maximum severity at any time point post-treatment)2

Common local skin reactions
(based on percentage of subjects)2

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References

  1. Data on file. Aclaris Therapeutics, Inc. 2017.

  2. ESKATA Full Prescribing Information. Aclaris Therapeutics, Inc. 2017.

INDICATIONS AND USAGE

ESKATA® (hydrogen peroxide) topical solution, 40% (w/w) is indicated for the treatment of seborrheic keratoses that are raised.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Do not apply ESKATA to the eyes or mucous membranes. Avoid treating seborrheic keratoses within the orbital rim. Direct contact with the eye can cause corneal injury (erosion, ulceration, perforation, and scarring), chemical conjunctivitis, eyelid edema, severe eye pain or permanent eye injury, including blindness. If accidental exposure occurs, flush with water for 15 to 30 minutes, initiate monitoring and further evaluation as appropriate.

Skin reactions occurred in the treatment area after application of ESKATA. Severe local skin reactions included erosion, ulceration, vesiculation and scarring. Do not re-treat until the skin has recovered from any reaction caused by the previous treatment.

MOST COMMON ADVERSE REACTIONS

The most common adverse reactions include erythema (99%), stinging (97%), edema (91%), scaling (90%), crusting (81%), and pruritus (58%).

CONTRAINDICATIONS

None.

DOSAGE AND ADMINISTRATION

ESKATA is to be administered by a healthcare provider. For topical use only. Not for oral, ophthalmic, or intravaginal use. Not for open or infected seborrheic keratoses.

Please see accompanying full Prescribing Information for ESKATA® (hydrogen peroxide) topical solution, 40% (w/w).