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Profile of woman in her mid-50s with rosacea grinning

Success as early as Week 21,2

Rosacea relief your patients can see

  • Patient 1, baseline, week 2, and week 12
  • Patient 1, baseline, week 4, and week 12
  • Patient 1, baseline, week 8, and week 12
  • Patient 2, baseline, week 2, and week 12
  • Patient 2, baseline, week 4, and week 12
  • Patient 2, baseline, week 8, and week 12
  • Patient 3, baseline, week 2, and week 12
  • Patient 3, baseline, week 4, and week 12
  • Patient 3, baseline, week 8, and week 12
  • Patient 4, baseline, week 2, and week 12
  • Patient 4, baseline, week 4, and week 12
  • Patient 4, baseline, week 8, and week 12

  • SUCCESS

    Study 54-02: Double-blind, randomized, vehicle-controlled safety and efficacy 12-week trial of EPSOLAY cream vs vehicle cream3

    Age: 54
    Female

  • SUCCESS

    Study 54-01: Double-blind, randomized, vehicle-controlled safety and efficacy 12-week trial of EPSOLAY cream vs vehicle cream3

    Age: 49
    Male

  • SUCCESS

    Study 54-02: Double-blind, randomized, vehicle-controlled safety and efficacy 12-week trial of EPSOLAY cream vs vehicle cream3

    Age: 36
    Female

  • FAILURE

    Study 54-01: Double-blind, randomized, vehicle-controlled safety and efficacy 12-week trial of EPSOLAY cream vs vehicle cream3

    Age: 29
    Female

EPSOLAY cream reduced nearly

70

of inflammatory lesions by Week 123

SEE STUDY DESIGN
  • 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)
Face of a woman with rosacea in her mid-30s grinning

Many patients were clear or almost clear by Week 12 as demonstrated by IGA success† in Pivotal Trials 1 and 2.3

Graph showing IGA success at Week 12
  • Graph showing IGA success at Week 12
  • Graph showing IGA success at Week 12

*Multiple imputation was used to impute missing values. Percent change at Week 2 represents the mean value obtained from averaging the summary statistics generated from each imputed data set (Table 14.2.2.1.1, CSR). Percent change at Week 12 represents the LS mean (Table 3, Prescribing Information).1-3

†The coprimary efficacy endpoints in both trials were the proportion of subjects 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 12.3

‡Based on multiple imputation analysis. In Pivotal Trial 1, 43.5% of subjects treated with EPSOLAY cream achieved IGA success vs 16.1% for vehicle (P<0.001). The respective values in Pivotal Trial 2 were 50.1% and 25.9% (P<0.001).1,2

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

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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