Efficacy of a new generation topical retinoid in the treatment of patients with moderate to severe acne on the face and trunk

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BACKGROUND: The extreme prevalence of acne, long-term course and multifactorial pathogenesis necessitate the development of new drugs and treatment methods aimed at increasing efficiency and achieving clinical effects in the shortest possible time. This article presents data from two international clinical studies to determine the effectiveness and safety of trifarotene 50 µg/g (0.005%) cream in the treatment of patients with moderate acne on the face and trunk.

AIM: To evaluate the safety and effectiveness of trifarotene cream, 0.005%, a new topical retinoid, for moderate acne of the face and trunk.

MATERIALS AND METHODS: Two international, double-blind, randomized, placebo (vehicle) controlled, 12-week phase III studies screened 2817 and randomized 2420 patients 9 years of age and over. The effectiveness of the drug was assessed based on the registration of the number of patients who achieved the effect of "clear" or "almost clear" skin condition and an improvement of ≥2 points in terms of IGA on the facial skin and PGA on the truncal skin during 12 weeks of treatment, as well as by calculating the change in absolute number of inflammatory and non-inflammatory acne elements relatively to the initial level. The safety of therapy was assessed based on the registration of adverse events, local tolerability (the formation and severity of retinoic dermatitis), abnormalities in vital signs and the results of standard laboratory tests.

RESULTS: The onset of effect of trifarotene versus that of its vehicle was rapid, with significant reductions in both inflammatory and noninflammatory lesion counts seen as early as 1 week after treatment on the face and as early as 2 weeks after treatment on the trunk. In both studies, at week 12 the facial success rates according to IGA and PGA and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (p <0.001) in favor of trifarotene when compared with the vehicle and the formation of the “almost clear” and “clean” effect was registered in the vast majority of patients, who used cream with 0.005% trifarotene.

CONCLUSION: The results of the study demonstrated the pronounced clinical effectiveness of trifarotene cream 0.005% in the treatment of patients with moderate acne on the skin of the face and trunk.

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作者简介

Yuri Perlamutrov

Russian University of Medicine

Email: y.perlamutrov@mail.ru
ORCID iD: 0000-0002-4837-8489
SPIN 代码: 2330-2758

MD, Dr. Sci. (Med.), Professor

俄罗斯联邦, Moscow

Kira Olkhovskaya

Russian University of Medicine

编辑信件的主要联系方式.
Email: olhovskaya_kira@mail.ru
ORCID iD: 0000-0003-4920-5288
SPIN 代码: 9455-9482

MD, Cand. Sci. (Med.), Associate Professor

俄罗斯联邦, Moscow

Anton Solovyov

Russian University of Medicine

Email: doctorsolovyov@mail.ru
ORCID iD: 0000-0003-3113-8929
SPIN 代码: 9676-9702

MD, Cand. Sci. (Med.), Associate Professor

俄罗斯联邦, Moscow

参考

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2. Fig. 5. Patient D, 19 years old, acne since the age of 18, has not been treated before: а ― IGA 2, PGA 0; b ― 12 weeks of therapy with trifarotene cream 0.005% 1 time per day + cleansing and moisturizing 2 times a day (IGA 0, PGA 0).

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3. Fig. 6. Patient D., 21 years old, acne from the age of 18, was previously treated with adapalene 0.1% gel and azelaic acid gel 15%: а–c ― IGA 3, PGA 2; 12 weeks of therapy with trifarotene cream 0.005% 1 time per day + cleansing and moisturizing 2 times a day (IGA 0, PGA 0).

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4. Fig. 7. Patient C., 18 years old, acne since the age of 16, has not been treated before: а ― IGA 2, PGA 0; b ― 12 weeks of therapy with trifarotene cream 0.005% 1 time per day + cleansing and moisturizing 2 times a day (IGA 0, PGA 0).

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5. Fig. 1. The effectiveness of therapy according to IGA PERFECT 1 (а) and PERFECT 2 (b).

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6. Fig. 2. The effectiveness of therapy according to PGA PERFECT 1(а) and PERFECT 2 (b).

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7. Fig. 3. Dynamics of the number of inflammatory and non-inflammatory acne elements on the skin of the face during treatment in the compared groups PERFECT 1 (а) and PERFECT 2 (b).

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8. Fig. 3. Ending.

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9. Fig. 4. Dynamics of the number of inflammatory and non-inflammatory acne elements on the skin of the trunk during treatment in the compared groups PERFECT 1 (а) and PERFECT 2 (b).

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