The US Food and Drug Administration (FDA) has approved once-daily tretinoin 0.05% lotion (Altreno, Ortho Dermatologics) for treatment of acne vulgaris in patients aged 9 years and older, making it the first tretinoin product to be available in lotion form.

While topical retinoids have proven highly effective in treating acne, they may be associated with skin irritation, such as dryness and peeling, and sensitivity. "In clinical trials, Altreno lotion provided the proven efficacy of tretinoin, a retinoid, in a generally well-tolerated formulation with skin dryness, pain, swelling, irritation and peeling reported in ≤4% of patients," the company said in a news release.

Altreno was evaluated in two phase 3, double-blind, vehicle-controlled clinical trials involving a total of 1640 patients aged 9 years and older. In both studies, Altreno lotion resulted in statistically significant reductions in both inflammatory and noninflammatory lesions compared with vehicle.

At week 12, 16.5% and 19.8% of Altreno-treated patients in trials 1 and 2, respectively, achieved treatment success, defined as at least a 2-grade improvement in global severity by Evaluator Global Severity Scores (EGSS) and EGSS score of clear or almost clear, compared with 6.9% and 12.5% of patients treated with vehicle. Patient satisfaction and acne quality-of-life assessments also favored Altreno over vehicle at week 12.


The most common adverse reactions occurring in more than 1% of participants and greater than with vehicle were dryness, pain erythema, irritation, and exfoliation.

Sunscreen and protective clothing should be worn when sun exposure cannot be avoided. Altreno should be used with caution in patients who are allergic to fish because of potential for allergenicity to fish protein. Full prescribing information is available online.  

The company expects Altreno to be available later this year.





(1)第一、二項研究數據顯示,在治療的第12周,與賦形劑組相比,Altreno治療組有更高比例的患者在EGSS方面取得成功分別為16.5% vs 6.9%,及19.8% vs 12.5%;非炎症性面部病變平均減少分別為47.5%(賦形劑組為27.3%),及45.%(賦形劑組為31.9%);炎症性面部病變平均減少50.9%(賦形劑組為40.4%),及53.4%(賦形劑組為41.5%)。
(3)與賦形劑組相比,Altreno治療組平均痤瘡-生活質量(Acne-QoL)評估結果有統計學意義的顯著提高:平均得分相對基線的變化:自我感知(7.4 vs 6.7,p=0.003)、角色-情感(7.4 vs 6.7,p=0.003)、社會角色(4.8 vs 4.6,p=0.038)、痤瘡症狀(6.5 vs 5.6,p<0.001)。



    FDA Approvals


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