Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne

Abstract

Background: Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied.Objectives: Assess the safety and efficacy of trifarotene 50 g/g cream, a novel topical retinoid, in moderate facial and truncal acne.Methods: Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and $2grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and $2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results.

Selective RAR agonists for acne vulgaris: A narrative review

“…The local adverse effects of trifarotene were limited to dryness, erythema, itching, scaling, and burning was of moderate severity and reached its maximum severity within 1 week for facial lesions and 2‐4 weeks for truncal lesions. Thereafter, the side effects diminished . Similar results were observed in a multicentric study by Blume et al Trifarotene treatment showed an overall success rate of 57.9% at the end of week 52 in treating face and truncal acne, as assessed by investigator and physician's global assessments (IGA, PGA) reference?…”

Truncal acne, what do we know?

“…To date, none of these products or procedures is officially indicated in the treatment of truncal acne. Very recently, a topical RAR‐δ‐specific retinoid was investigated specifically in the treatment of moderate acne on the trunk 4 …”

Subject Satisfaction with Trifarotene 50 μg/g Cream in the Treatment of Facial and Truncal Acne Vulgaris: A Case Series

“…On his questionnaire, he reported that irritation was manageable with the use of the provided noncomedogenic moisturizer and gentle cleanser. As in the large-scale, pivotal studies, the implementation of routine standard skin care and dosing regimen adjustments were encouraged to mitigate any tolerability issues and ensure compliance [ 10 ]. All three cases used the provided moisturizing lotion and continued the treatment for the full 12 weeks, highlighting the importance of educating patients on how to manage irritation, which may occur during the first weeks of acne treatment, to improve treatment adherence, efficacy and patient satisfaction [ 14 ].…”

“…Retinoids are widely used in the management of acne [ 5 – 7 ]. Topical trifarotene (AKLIEF® Cream 0.005%; Galderma) is the first new retinoid molecule approved in the USA in over 20 years for the once-daily topical treatment of acne vulgaris [ 8 – 10 ]. Trifarotene 50 μg/g cream first received approval in the USA in October 2019, followed by Canada in November 2019 and Europe in December 2019.…”

“…Previously developed retinoids were evaluated only in facial acne and not truncal acne, possibly due to safety concerns about treating a large area or a lack of consideration for truncal acne and its prevalence. Trifarotene 50 μg/g cream was evaluated in both moderate facial and truncal acne in two large-scale, randomized, double-blind, vehicle-controlled studies and one long-term safety study [ 10 , 12 ]. As physicians have had little real-world experience with its qualities, reporting from the patient’s perspective provides a valuable adjunct to the results of these pivotal studies.…”