Clinical Trials and Efficacy

Clinical Trials and Efficacy


Clinical Trials And Efficacy

FABIOR Foam was studied as monotherapy in patients with moderate-to-severe acne

FABIOR Foam was studied in 2 randomized, double-blind, vehicle-controlled studies of 1485 patients aged 12 to 45 years1

  • 51% of patients were female, 49% of patients were male
  • 58% of patients were between the ages of 12 and 17
  • 77% of patients were white, 15% of patients were black, 8% were race other than white or black
  • At baseline, 80% of patients were assessed as moderate (IGA 3), and 20% of patients were assessed as severe (IGA 4)

Patients were randomized 1:1 to FABIOR Foam or vehicle foam, applied once daily for 12 weeks1

  • While patients were required to treat the face, they were also permitted to treat the trunk
  • Use of concomitant acne treatments was not permitted

Efficacy was evaluated using lesion counts and the 6-point Investigator’s Global Assessment (IGA) scale2

  • Absolute change in lesion counts (total, inflammatory, and non-inflammatory) from baseline to week 12
  • Treatment success, which was defined as an IGA score of "clear" (grade 0) or "almost clear" (grade 1) and at least a 2-grade improvement from the baseline score at week 12.

Clinical results achieved with FABIOR Foam: actual patients from clinical trials

Patient 1*

Patients achieved clinical results with FABIOR Foam at Week 12

Baseline

Patients achieved clinical results with FABIOR Foam at Week 12

Week 12

Patient 2*

Patients achieved clinical results with FABIOR Foam at Week 12

Baseline

Patients achieved clinical results with FABIOR Foam at Week 12

Week 12

*Actual patients from clinical trials whose facial features have been modified to protect their confidentiality. Representative of clinical trial efficacy. Individual results may vary.

FABIOR Foam, used as monotherapy in moderate-to-severe acne patients, demonstrated a statistically significant reduction in total acne lesions, inflammatory lesions, and non-inflammatory lesions.2

Reduction in acne lesions at week 12 compared with baseline

Bar Graph demonstrating FABIOR Foam Provided More Reduction In Acne Lesions At Week 12 Compared To Patients Using Vehicle Foam

FABIOR Foam demonstrated statistically significant efficacy as early as week 2, with continued improvement for the duration of the study.

Reduction in total acne lesions over time2

Line Graph demonstrating FABIOR Foam Provided More Reduction In Total Acne Lesions Over Tme Compared To Patients Using Vehicle Foam

Significantly more patients achieved treatment success with FABIOR Foam compared with vehicle foam at week 12.

Percentage of patients achieving treatment success3

Bar Graph demonstrating More Patients Using FABIOR Foam Achieved Treatment Success At Week 12 Vs Patients Using Vehicle Foam

Treatment success was defined as an IGA score of “clear” (grade 0) or “almost clear” (grade 1) and at least a 2-grade improvement from the baseline score at week 12.

Investigator’s Global Assessment (IGA) Scale

Investigator’s Global Assessment (IGA) Scale

References: 1. FABIOR Foam [package insert]. Greenville, NC: Mayne Pharma; 2016. 2. Stein Gold L, Jasper S. Tazarotene foam 0.1% for Acne Vulgaris: analysis of integrated efficacy and safety data by race. Presented at: Proceedings of the Summer Academy Meeting American Academy of Dermatology; August 15-19, 2012; Boston, MA. 3. Data on file; Greenville, NC: Mayne Pharma LLC.

Indication

FABIOR Foam is a retinoid indicated for the topical treatment of acne vulgaris in patients 12 years of age or older.

For more information, please see full Prescribing Information and Patient Information Leaflet

Important Safety Information

  • FABIOR Foam is contraindicated in pregnancy. FABIOR Foam may cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, treatment should be discontinued and the patient apprised of the potential hazard to the fetus. Females of child-bearing potential should be warned of the potential risk and use of adequate birth-control measures when tazarotene foam is used. The possibility of pregnancy should be considered in females of child-bearing potential at the time of institution of therapy.
  • FABIOR Foam should be used with caution in patients with history of local tolerability reactions or local hypersensitivity.
  • The propellant in FABIOR Foam is flammable. Instruct the patient to avoid fire, flame, and/or smoking during and immediately following application.
  • Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided when using FABIOR Foam. Patients must be warned to use sunscreens and protective clothing. Patients with sunburn should be advised not to use FABIOR Foam until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients with inherent sensitivity to sunlight should exercise particular caution. FABIOR Foam should be used with caution in patients with a personal or family history of skin cancer or if the patient is also taking drugs known to be photosensitizers.
  • FABIOR Foam may cause skin redness, peeling, burning, or excessive pruritus. Concomitant topical acne therapy should be used with caution because a cumulative irritant effect may occur. If skin irritation occurs, therapy with FABIOR Foam should be reduced to an interval the patient can tolerate, temporarily interrupted, or discontinued. In addition, dermatologic medications and cosmetics that have a strong drying effect should be avoided
  • Retinoids should not be used on abraded or eczematous skin, as they may cause severe irritation. Contact with the mouth, eyes, and mucous membranes should be avoided. Weather extremes, such as wind or cold, may be more irritating to patients using FABIOR Foam. Excessive topical application of FABIOR Foam may lead to marked redness, peeling, or discomfort.

Medical Information & Adverse Drug Events Reporting

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.