Eskata

What is Eskata and how is it used?

Eskata is a prescription medicine used to treat the symptoms of Seborrheic Keratosis. Eskata may be used alone or with other medications.

Eskata belongs to a class of drugs called Topical Skin Products.

It is not known if Eskata is safe and effective in children.

What are the possible side effects of Eskata?

Eskata may cause serious side effects including:

• redness or blistering of the skin,
• peeling,  
• burning of the skin,
• itching,
• pain,
• rash,
• stinging,
• ulcerations,
• cracking or scarring of the skin,
• thinning skin,
• swelling of the eyelid, and
• blisters on the body

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Eskata include:

• discoloration,
• dry, peeling, or crusting of the skin,
• lightening of the skin color, and
• lightening of the treated areas of dark skin

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Eskata. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

ESKATA (hydrogen peroxide) topical solution, 40% (w/w) is a clear, colorless solution for topical administration, which contains the active ingredient, hydrogen peroxide.

The chemical name of hydrogen peroxide is dihydrogen dioxide.

The molecular formula of hydrogen peroxide is H₂O₂ and the molecular weight is 34.01. Hydrogen peroxide is represented by the following structural formula:

ESKATA contains 40% (w/w) hydrogen peroxide in an aqueous solution of isopropyl alcohol and water.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Important Administration Information

ESKATA is to be administered by a health care provider.

For topical use only. Not for oral, ophthalmic, or intravaginal use.

Do not apply ESKATA topical solution to open or infected seborrheic keratoses.

Prior to application of ESKATA, ensure the surface of seborrheic keratosis lesion is clear of oil and debris (an alcohol wipe can be used).

During a single in-office treatment session, apply ESKATA to seborrheic keratosis lesions 4 times, approximately 1 minute apart. After one use, replace the cap and discard the unit dose applicator.

When treating seborrheic keratoses on the face, take appropriate actions to ensure that ESKATA will not come into contact with the eyes.

If the treated lesions have not completely cleared approximately 3 weeks after treatment, another treatment may be administered following the same procedure.

Dosage And Administration Instructions

Preparation Of The ESKATA Applicator

Wear nitrile or vinyl examination gloves during the activation of the ESKATA applicator and during the administration of the solution to the lesion(s).

The method for preparing the ESKATA applicator for use is illustrated below. While activating the applicator, hold it away from the patient. Do not remove the cap until after completion of Step 4 (below).

Step 1: Hold the ESKATA applicator so that the applicator cap is pointing up

Step 2: Crush the ampule in the applicator by applying finger pressure to the diamond symbol on the applicator barrel

Step 3: Remove the sleeve.

Step 4: Holding the applicator with cap pointing up, tap the bottom of the applicator to separate the solution from the crushed ampule.

Application Of ESKATA Topical Solution

Following release of the solution from the ampule, remove the cap from the ESKATA applicator. Gently squeeze the applicator barrel to express the solution to the applicator tip. Using the applicator, apply the solution directly to the seborrheic keratosis in a circular motion. Apply enough solution to uniformly wet the lesion surface, including the edges without excess running or dripping.

Wait 1 minute and observe. Whitening of the lesion may occur.

Do not progress to subsequent applications if severe erythema/edema or pain occur. Apply again in the same manner 3 additional applications 1 minute apart.

Minimize the amount of drug that comes into contact with surrounding skin. If ESKATA does come into contact with surrounding skin, use an absorbent wipe to remove any excess solution (do not use paper towels or tissue).

HOW SUPPLIED

Dosage Forms And Strengths

ESKATA topical solution is a clear, colorless solution containing 40% (w/w) hydrogen peroxide.

Storage And Handling

ESKATA (hydrogen peroxide) topical solution, 40% (w/w) is a clear, colorless solution and is supplied in a unit dose package. The available carton packages are presented below:

Dosage Strength	Fill Volume	Deliverable Volume	Number of unit dose packages per carton	NDC#
40% (w/w)	1.5 mL	0.7 mL	1	71180-001-01
			3	71180-001-03
			12	71180-001-12
	2.2 mL	1.3 mL	1	71180-002-01
			3	71180-002-03
			12	71180-002-12

Store ESKATA at controlled room temperature of 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59° F and 86° F).

Manufactured & Packaged by: James Alexander Corp., 845 Route 94, Blairstown, NJ 07825, United States. For: Aclaris Therapeutics, Inc., 640 Lee Road, Suite 200, Wayne, PA 19087, United States. Revised: Feb 2019

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to ESKATA or vehicle in a total of 937 subjects with seborrheic keratoses that are raised. Overall, 42% of the subjects were male and 58% were female. Ninety-eight (98) percent of the subjects were Caucasian and the mean age was 68.7 years.

At each visit, local skin reactions were graded for severity to determine the maximum severity after treatment. Table 1 presents the percentage of subjects with the local adverse reactions by the most severe grade reported during the course of the trials.

Table 1: Percentage of Subjects with Local Skin Reactions by Severity

	ESKATA N=467				Vehicle N=470
	Mild	Moderate	Severe	Total	Mild	Moderate	Severe	Total
Erythema	13	67	19	99	29	5	<1	34
Stinging	34	49	15	97	9	1	<1	10
Edema	28	48	15	91	6	1	0	6
Scaling	49	36	5	90	28	5	1	33
Crusting	34	38	8	81	13	5	1	19
Pruritus	34	18	5	58	7	1	<1	8
Hyperpigmentation	32	7	<1	39	1	<1	0	1
Vesicles	21	3	1	24	<1	0	0	<1
Hypopigmentation	16	3	<1	19	1	<1	0	1
Erosion	12	2	1	15	<1	0	0	1
Ulceration	6	2	<1	9	1	1	0	2
Atrophy	4	0	0	4	0	0	0	0
Scarring	3	<1	<1	3	0	0	0	0

Common local skin reactions observed 10 minutes after treatment include: erythema (98%), stinging (93%), edema (85%), pruritus (32%), and vesiculation (18%).

Common local skin reactions observed 1 week after treatment are scaling (72%), erythema (66%), crusting (67%), pruritus (18%), erosion (9%), and ulceration (4%).

Common local skin reactions observed 15 weeks after the initial treatment are erythema (21%), hyperpigmentation (18%), scaling (16%), crusting (12%), and hypopigmentation (7%).

Less common adverse reactions occurring in ≥ 0.5% of subjects treated with ESKATA include eyelid edema (0.6%) and herpes zoster (0.6%).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ESKATA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin and subcutaneous tissues disorders: crepitus

DRUG INTERACTIONS

No Information provided

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Eye Disorders

Do not apply 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 and initiate monitoring, and further evaluation as appropriate.

Local Skin Reactions

Skin reactions occurred in the treatment area after application of ESKATA. Severe local skin reactions included erosion, ulceration, vesiculation and scarring. [See ADVERSE REACTIONS]. Do not initiate a second treatment course with ESKATA until the skin has recovered from any reaction caused by the previous treatment.

Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION).

Ophthalmic Adverse Reactions

Inform patients that severe eye injury can occur with ESKATA application. Advise patients to inform the healthcare provider immediately if ESKATA runs into eyes, mouth, or nose during administration [see WARNINGS AND PRECAUTIONS].

Local Skin Reactions

Inform patients that treatment with ESKATA may lead to local skin reactions [see WARNINGS AND PRECAUTIONS].

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of ESKATA or hydrogen peroxide.

Hydrogen peroxide has been found to exhibit positive results in in vitro tests for genotoxicity, but has not exhibited positive results in in vivo tests for genotoxicity, presumably due to the rapid metabolism of hydrogen peroxide.

The effects of hydrogen peroxide on fertility have not been evaluated. Hydrogen peroxide has been associated with effects on sperm function and elevated testicular hydrogen peroxide concentration has been implicated in male infertility, although in vivo, no effect of hydrogen peroxide on sperm function has been demonstrated.

Use In Specific Populations

Pregnancy

Risk Summary

Hydrogen peroxide is not absorbed systemically following topical administration, and maternal use is not expected to result in fetal exposure to the drug.

Lactation

Risk Summary

Hydrogen peroxide is not absorbed systemically by the mother following topical administration, and breastfeeding is not expected to result in exposure of the child to hydrogen peroxide.

Pediatric Use

Seborrheic keratosis is not seen in the pediatric population.

Geriatric Use

Of the 841 subjects treated with ESKATA in the clinical trials, 70% were 65 years of age and older and 26% were 75 years of age and older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

OVERDOSE

Topical overdosing of ESKATA could result in an increased incidence and severity of local skin reactions.

CONTRAINDICATIONS

None.

CLINICAL PHARMACOLOGY

Mechanism Of Action

The mechanism of action for ESKATA for the treatment of seborrheic keratosis is unknown.

Pharmacodynamics

The pharmacodynamics of ESKATA in the treatment of seborrheic keratosis are unknown.

Pharmacokinetics

Following application of ESKATA in patients with seborrheic keratosis lesions, hydrogen peroxide rapidly dissociates into water and reactive oxygen species. Indirect assessment of reactive oxygen species in patients with seborrheic keratosis lesions did not demonstrate any systemic absorption of hydrogen peroxide.

Clinical Studies

In two double-blind, vehicle-controlled clinical trials, 937 subjects with 4 clinically typical seborrheic keratoses that are raised on the face, trunk, or extremities were randomized to treatment with either ESKATA or vehicle. Subjects ranged from 42 to 91 years of age (mean 68.7 years), 58% percent were female, and 98% were Caucasian. A total of 925 subjects completed the trials. Each lesion was treated with 4 applications, at baseline and again at Day 22, if needed, and subjects were followed through Day 106.

Efficacy was assessed at Day 106. Success rate was defined as the proportion of subjects achieving “clear” on the Physician's Lesion Assessment Scale for all 4 treated lesions. Efficacy was also assessed for the proportion of subjects achieving “clear” on the Physician's Lesion Assessment Scale for at least 3 of 4 lesions. Table 3 presents the efficacy results for the two clinical trials.

Table 3: Percentage of Subjects Achieving Clearance of Target Lesions at Day 106 in Study 1 and Study 2

	Study 1		Study 2
	ESKATA N=223	Vehicle N=227	ESKATA N=244	Vehicle N=243
All 4 lesions “Clear”	4%	0%	8%	0%
At least 3 of 4 lesions “Clear”	13%	0%	23%	0%

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS AND PRECAUTIONS sections.