Pharmacology Update

Tazarotene Foam, 0.1% (Fabior™)

By William T. Elliott, MD, FACP, and James Chan, PharmD, PhD. Dr. Elliott is Chair, Formulary Committee, Northern California Kaiser Permanente; and Assistant Professor of Medicine, University of California, San Francisco. Dr. Chan is Pharmacy Quality and Outcomes Manager, Kaiser Permanente, Oakland, CA. Drs. Elliott and Chan report no financial relationships relevant to this field of study.

The first retinoid as a topical foam has been approved by the FDA for the treatment of acne. Tazarotene is a synthetic, third-generation, polyaromatic, prodrug that binds to the retinoic acid receptors. Tazarotene is available in both gel and cream formulations. The foam is marketed by Stiefel as Fabior™.

Indications

Tazarotene foam is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.1

Dosage

Tazarotene is applied as a thin layer to the affected areas of the face and upper trunk once daily in the evening.1

Tazarotene foam is available as a 0.1% foam.

Potential Advantages

The foam provides another formulation of tazarotene, in addition to the gel and cream.

Potential Disadvantages

The propellant in the foam is flammable and the patient should avoid the presence of fire, flame, and smoking during and immediately following application. Tazarotene is a photosensitizer; therefore sun (actual or artificial) should be avoided. Most frequently reported adverse events are related to the site of application. These include irritation, dryness, erythema, and exfoliation.1

Comments

The efficacy of tazarotene foam was evaluated in two randomized, double-blind, 12-week, vehicle-controlled studies in patients with moderate-to-severe acne vulgaris.1 Eighty percent of subjects had moderate acne and 20% had severe acne. The mean number of lesions were 31.9 (inflammatory) and 47.8 (non-inflammatory). Subjects (n = 1485) were randomized to tazarotene foam or vehicle applied once daily. Efficacy endpoints were reduction in inflammatory lesion non-inflammatory lesion counts and the Investigator's Global Assessment (IGA). The latter is a 6-grade scale assessing disease severity. For the two studies, tazarotene reduced inflammatory lesion counts by 55% to 58% compared to 45% for the vehicle. Non-inflammatory lesions were reduced by 55% to 57% compared to 33% to 41% for vehicle. Twenty-eight to 29% of subjects showed a minimum of a 2-grade improvement compared to 13% to 16% for the vehicle. Adverse events were limited to application site. The most frequently reported adverse events compared to placebo were irritation (14% vs 1%), dryness (7% vs 1%), erythema, and exfoliation (6% vs < 1%). There are currently no published comparisons between tazarotene foam and cream or gel formulations or to other retinoids such as adapalene. The benefit compared to vehicle appeared similar to that reported for tazarotene cream and gel.2,3

Clinical Implications

Tazarotene foam provides another formulation of a retinoid for moderate-to-severe acne. The cream and gel formulations have been available for more than a decade. Topical retinoids are mainstays of acne treatment.4 The American Academy of Dermatology indicated that there is no consensus as to relative efficacy of the various retinoids. However, others have suggested that tazarotene may be more effective than adapalene, but adapalene may be better tolerated.5-7

References

1. Fabior™ Prescribing Information. Research Triangle Park, NC: Stiefel Laboratories; May 2012.

2. Tazorac® Cream Prescribing Information. Irvine, CA: Allergan; February 2011.

3. Tazorac® Gel Prescribing Information. Irvine, CA: Allergan; March 2011.

4. Strauss JS, et al. Guidelines of care for acne vulgaris management. J Am Acad Dermatol 2007;56:651-663.

5. Thiboutot D, et al. Efficacy and tolerability of adapalene 0.3% gel compared to tazarotene 0.1% gel in the treatment of acne vulgaris. J Drugs Dermatol 2008;7(6 Suppl):s3-s10.

6. Thielitz A, et al. Topical retinoids in acne — an evidence-based overview. J Dtsch Dermatol Ges 2008; 6:1023-1031.

7. Leyden JJ, et al. Topical retinoids in inflammatory acne: A retrospective, investigator-blinded, vehicle-controlled, photographic assessment. Clin Ther 2005;27:216-224.