The FDA approved Fabior™ (tazarotene) Foam, 0.1%, in May 2012 to treat patients ≥12 years of age who have acne vulgaris. The product, marketed by Stiefel, is the only FDA-approved retinoid in a topical foam formulation.
Patients are advised to apply a thin layer of tazarotene foam to affected areas of the face and/or upper trunk once daily at night. Before applying the foam, patients should wash their hands and dry the affected areas. They should also avoid applying the foam to their eyes, lips, and mucous membranes.
Tazarotene foam is only approved as a topical treatment and is not intended for oral, ophthalmic, or intravaginal use. The foam also contains tazarotene, which is a teratogenic substance contraindicated in pregnancy. In addition, patients should not use concomitant dermatologic medications and cosmetics with a strong drying effect.
In a news release, Stiefel noted that approximately 40 million to 50 million people in the United States have acne vulgaris, which is the most common skin problem in the United States.
The FDA approved tazarotene foam based on the results of 2 randomized, double-blind, vehicle-controlled, parallel-group, phase 3 studies conducted at 39 centers in the United States and Canada. Patients were between 12 and 45 years of age and had acne vulgaris.
This First Report Managed Care Product Spotlight provides a summary of the pivotal trials that evaluated the safety and efficacy of tazarotene foam.
Phase 3 Trials
Below is a summary of 2 randomized, double-blind, vehicle-controlled, parallel-group studies that assessed the clinical efficacy of tazarotene foam in patients compared with vehicle foam in patients with moderate to severe acne vulgaris.
Feldman SR, Werner CP, et al. The efficacy and tolerability of tazarotene foam, 0.1%, in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013;12(4):438-446.
The trial was designed to evaluate the efficacy and tolerability of tazarotene foam in adults and adolescents with acne vulgaris.
In the first study, conducted from October 16, 2009, to November 11, 2010, the authors randomized 744 patients in a 1:1 ratio to receive tazarotene foam or vehicle foam. The second study took place from October 28, 2009, to November 15, 2010 and included 742 patients who were randomized in a 1:1 ratio to receive tazarotene foam or vehicle foam. There were a total of 39 centers in the studies: 32 in the United States and 7 in Canada.
The vehicle foam had the same ingredients as the tazarotene foam with the exception of the active ingredient. Both foams had the same packaging, as well.
Patients applied the foams once daily each night for 12 weeks. They were required to wash their faces with a mild nonantimicrobial soap or soap-free cleanser and have the area dry fully before applying the foam. They were instructed to apply the foam to cover their face and avoid applying the foam to their eyes, nose, or mouth.
The authors assessed the efficacy, safety, and tolerability of the foams at baseline and at weeks 2, 4, 8, and 12. At each of those visits, they evaluated lesion counts, assessed the patient’s Investigator’s Static Global Assessment (ISGA) scores, and recorded erythema, dryness, peeling, itching, and burning/stinging.
Patients were eligible if they were between 12 and 45 years of age, were in good health, and agreed to use a medically acceptable form of contraception. They also had lesion counts of 25 to 50 facial inflammatory lesions with no more than 1 facial nodular lesion and no cystic lesions, 30 to 125 facial noninflammatory lesions, and an ISGA score ≥3 at baseline.
Patients were excluded if they could not tolerate tazarotene or any of the product’s other ingredients. The authors also required patients who took certain topical and systemic treatments to have specified washout periods.
In both studies, the treatment groups were well balanced. Mean age was approximately 19 years of age, approximately half of patients were male, and approximately 80% were white.
Primary end points
· Absolute change in lesion counts from baseline to week 12
· Proportion of patients with a minimum 2-grade improvement in ISGA score from baseline to week 12
· Proportion of participants with an ISGA score of 0 (clear skin) or 1 (almost clear skin) at week 12
Secondary end points
· Absolute change in lesion counts from baseline to weeks 2, 4, and 8
· Percentage change in lesion counts from baseline to weeks 2, 4, 8, and 12
· Time to 50% reduction in total lesion counts
· Proportion of patients with a minimum 2-grade improvement in ISGA score from baseline to weeks 2, 4, and 8
After 12 weeks of treatment, patients in the tazarotene foam group had greater decreases in lesion counts, a greater proportion of patients with ≥2-grade improvement in ISGA score, and a greater proportion of participants with an ISGA score of 0 or 1.
Compared with the vehicle foam group, there were 16.2 fewer lesions in the tazarotene foam group in the first study (P<.001) and 12.2 fewer lesions in the tazarotene foam group in the second study (P<.001). In each study, the differences in inflammatory and noninflammatory lesions were significantly larger in the tazarotene foam group (P<.001 in all comparisons).
At week 12 in the first study, 35.6% of patients in the tazarotene foam group had a minimum 2-grade improvement in ISGA score compared with 23.9% of patients in the vehicle foam group (P≤.01). In the second study, 32.2% of patients in the tazarotene foam group had a minimum 2-grade improvement in ISGA score after 12 weeks compared with 18.2% of patients in the vehicle foam group (P≤.01).
Further, 28.8% of patients in the first study who received tazarotene foam had an ISGA score of 0 or 1 compared with 16.1% of patients who took vehicle foam (P≤.01), while 27.6% of patients in the second study who received tazarotene foam had an ISGA score of 0 or 1 compared with 13.3% of patients who took vehicle foam (P≤.01).
The product’s Prescribing Information mentions that the following adverse reactions were found in at least 6% of patients who received tazarotene foam: application site irritation, application site dryness, application site erythema, and application site exfoliation.
Healthcare professionals are advised to tell patients of the fetal risk associated with tazarotene foam and that patients should avoid exposure of the treated areas with sunlight, avoid contact with the eyes, avoid putting the foam in the freezer, and interrupt treatment if they have undue irritation such as redness, peeling, or discomfort.
• Fabior was approved by the FDA on May, 11, 2012, to treat patients with acne vulgaris
• Fabior is marketed by Stiefel
Prescribing Information for Fabior: stiefel.com