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Tazarotene shows favorable risk-benefit ratio for acne vulgaris
Tazarotene 0.045% lotion was associated with significant lesion reduction with a favorable adverse event profile in moderate to severe acne vulgaris, according to recent findings.
“I have studied tazarotene since it was first developed by Allergan over 20 years ago,” Emil A. Tanghetti MD, of the Center for Dermatology and Laser Surgery in Sacramento, Calif., told Healio Dermatology. “I was particularly impressed with its use in the treatment of psoriasis, acne and photodamage. Ortho has developed formulations of the drug for acne and psoriasis with this polymeric vehicle. I welcomed the opportunity to use this drug with an improved formulation and delivery.”
Tanghetti and colleagues suggested that although tazarotene has undergone rigorous study and is regularly used in clinical practice, irritation from all three formulations — cream, foam and gel — may be limiting its use.
In the current study, the researchers investigated the efficacy, safety and tolerability of the lotion formulation of tazarotene 0.045% in a cohort of 1,614 patients aged 9 years or older.
Eligible participants in the double-blind, randomized, vehicle-controlled analysis were randomly assigned active therapy or vehicle in two identical, parallel studies.
Endpoints included inflammatory events such as papules and pustules and non-inflammatory comedonal lesion counts as assessed by Evaluator Global Severity Scores (EGSS). The researchers defined a successful treatment regimen as yielding at least a 2-grade improvement in EGSS and a reduction in lesion counts leading to a “clear” or “almost clear” assessment. Patients also completed the Acne-Specific Quality of Life (Acne-QoL) questionnaire.
Week 12 results in the first of the two studies showed a mean reduction in inflammatory lesions of 55.5% with tazarotene 0.045% lotion, compared with a 45.7% reduction for vehicle (P < .001). At the same point in the first study, non-inflammatory lesions decreased by 51.4% with the study drug and 41.5% for vehicle (P < .001).
In the second study, week 12 results showed a 59.5% reduction in inflammatory lesions for tazarotene 0.1% and 49.0% for vehicle (P < .001), while non-inflammatory lesions decreased by 60.0% for tazarotene 0.1% and 41.6% for vehicle (P < .001).
Treatment success rates for tazarotene 0.045% were 25.5% for the first study and 29.6% for the second. By comparison, vehicle was associated with treatment success rates of 13.0% (P < .001) in the first study and 17.3% (P < .001) in the second.
The study lotion was also associated with consistent improvement in QOL scores.
Tolerability data showed that application site pain occurred in 5.3% of the cohort, dryness in 3.6% and exfoliation in 2.1%.
“The main message is that this product is a dramatic improvement in the formulation and delivery of tazarotene, which permits efficacy that is comparable if not better than the older cream formulations at half the drug concentration,” Tanghetti said. “This results in significantly improved tolerability, which was always an impediment towards wider use of this particularly effective topical retinoid. The polymeric vehicle permits the simultaneous delivery of the drug and emollients in cosmetically elegant preparation, which is highly spreadable, permitting it to be used on the face, chest, back and other areas with acne.” – by Rob Volansky
Disclosures: Tanghetti reports being a speaker for Abbvie, Dermira, Galderma, Lilly, Novartis, Ortho Dermatologics, Sun; serving as a consultant and conducting clinical studies for Galderma, Hologic and Ortho Dermatologics, and being a stockholder for Accure.