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Microencapsulated benzoyl peroxide highlighted on a finger for the EPSOLAY cream campaign

Designed with sensitive rosacea skin in mind1-3

EPSOLAY cream was well tolerated by patients with sensitive rosacea skin1

Adverse reactions reported by ≥1% of patients in the 12-week pivotal trials treated with EPSOLAY cream and more frequently than with vehicle cream, all on application site1
Chart showing adverse reactions reported by ≥1% of patients treated with EPSOLAY cream and more frequently than with vehicle cream, all on application site
Mean assessment of tolerability scores were below mild for both EPSOLAY cream and vehicle cream throughout the study3,4
  • Graph showing mean absolute change in inflammatory lesion counts over time (Pivotal Trial 1)
  • Graph showing mean absolute change in inflammatory lesion counts over time (Pivotal Trial 2)
  • Graph showing mean absolute change in inflammatory lesion counts over time (Pivotal Trial 1)
  • Graph showing mean absolute change in inflammatory lesion counts over time (Pivotal Trial 2)

EPSOLAY cream has a delicate touch, making it suitable for long-term use1,3-5

<1%

of patients in the long-term study discontinued due to adverse reactions5

Facial cutaneous and tolerability assessment by severity at Week 525
Chart showing facial cutaneous and tolerability assessment by severity at Week 52

Long-term safety results were comparable to results of the two 12-week studies.1

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*Application site edema includes application site swelling and application site edema.1

References: 1. EPSOLAY (benzoyl peroxide) cream, 5% [Prescribing Information]. Whippany, NJ: Sol-Gel Technologies Ltd.; April 2021. 2. Data on File. Galderma Laboratories, L.P. 3. Galderma Laboratories, L.P.; data on file. Clinical Study Report SGT-54-01; January 8, 2020. 4. Galderma Laboratories, L.P.; data on file. Clinical Study Report SGT-54-02; March 26, 2020. 5. Galderma Laboratories, L.P.; data on file. Clinical Study Report SGT-54-07; March 30, 2020.

IMPORTANT SAFETY INFORMATION

Indication: EPSOLAY® (benzoyl peroxide) Cream, 5% is indicated for the treatment of inflammatory lesions of rosacea in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with EPSOLAY Cream were pain, erythema (redness), pruritus (itching) and edema (swelling), all at the application site. Warnings/Precautions: Patients using EPSOLAY Cream may experience hypersensitivity reactions, including anaphylaxis (acute allergic reaction), angioedema (rapid swelling), and urticaria (hives). If serious hypersensitivity reaction occurs, discontinue use of EPSOLAY Cream immediately and seek medical attention/initiate appropriate therapy. Skin Irritation/contact dermatitis may be experienced, including erythema (redness), scaling, dryness, and stinging/burning. Irritation and contact dermatitis may occur. Use a moisturizer and discontinue EPSOLAY Cream if symptoms do not improve. Avoid application to cuts, abrasions, eczematous, or sunburned skin. EPSOLAY Cream may increase photosensitivity, sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). Use sunscreen or protective clothing when sun exposure cannot be avoided. Discontinue use of EPSOLAY Cream at the first evidence of sunburn.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

IMPORTANT SAFETY INFORMATION

Indication: EPSOLAY® (benzoyl peroxide) Cream, 5% is indicated for the treatment of inflammatory lesions of rosacea in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with EPSOLAY Cream were pain, erythema (redness), pruritus (itching) and edema (swelling), all at the application site. Warnings/Precautions: Patients using EPSOLAY Cream may experience hypersensitivity reactions, including anaphylaxis (acute allergic reaction), angioedema (rapid swelling), and urticaria (hives). If serious hypersensitivity reaction occurs, discontinue use of EPSOLAY Cream immediately and seek medical attention/initiate appropriate therapy. Skin Irritation/contact dermatitis may be experienced, including erythema (redness), scaling, dryness, and stinging/burning. Irritation and contact dermatitis may occur. Use a moisturizer and discontinue EPSOLAY Cream if symptoms do not improve. Avoid application to cuts, abrasions, eczematous, or sunburned skin. EPSOLAY Cream may increase photosensitivity, sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). Use sunscreen or protective clothing when sun exposure cannot be avoided. Discontinue use of EPSOLAY Cream at the first evidence of sunburn.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088

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STUDY DESIGN3

The safety and efficacy of EPSOLAY cream was evaluated in 2 multicenter, randomized, double-blind, vehicle-controlled trials in patients with moderate to severe papulopustular rosacea. In Pivotal Trial 1, 243 patients used EPSOLAY cream and 118 used vehicle cream. In Pivotal Trial 2, 250 patients used EPSOLAY cream and 122 used vehicle cream.

Patients were treated once daily for 12 weeks with either EPSOLAY cream or vehicle cream.

Patients were required to have a minimum of 15 to 70 total inflammatory lesions (papules and/or pustules) and no more than 2 nodules (where a nodule was defined as a papule or pustule greater than 5 mm in diameter) and an Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline.

At baseline, patients had a mean inflammatory lesion count of 27.5, 89% were scored as moderate (IGA=3), and 11% scored as severe (IGA=4).

The coprimary efficacy endpoints in both trials were the proportion of patients with treatment success at Week 12, defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline, and the absolute change from baseline in inflammatory lesion counts at Week 12.

STUDY DESIGN4

The long-term safety and tolerability of daily use of EPSOLAY cream were evaluated in an open-label, long-term safety study in papulopustular rosacea patients from the 2 double-blind pivotal trials. A total of 547 patients were enrolled, including 363 patients previously treated with EPSOLAY cream and 184 patients previously treated with vehicle cream.

Patients were treated with EPSOLAY cream once daily from baseline through Week 40 with an IGA score for rosacea assessed as mild, moderate, or severe. If a patient was assessed as clear or almost clear, patients were not dispensed the study product until relapse was assessed.

Patients were required to have completed 12 weeks or be within the Week 12 window time (±4 days) of the double-blind treatment period of the pivotal trials and missed not more than 1 visit of Visits 3, 4, or 5 in the pivotal trials.

At baseline, patients had a mean inflammatory lesion count of 28.4, 89.2% were scored as moderate (IGA=3), and 10.8% were scored as severe (IGA=4).

Safety was evaluated by monitoring adverse events, cutaneous safety (dryness and scaling), and local tolerability (itching and burning/stinging) assessments, physical examinations, and vital signs. The study was not intended to assess efficacy. Certain efficacy data and endpoints were, however, summarized.

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