Efficacy of a new generation topical retinoid in the treatment of patients with moderate to severe acne on the face and trunk
- Authors: Olkhovskaya K., Perlamutrov Y., Solovyov A.
- Section: DERMATOLOGY
- Submitted: 05.05.2024
- Accepted: 12.06.2024
- Published: 12.06.2024
- URL: https://rjsvd.com/1560-9588/article/view/631689
- DOI: https://doi.org/10.17816/dv631689
- ID: 631689
Cite item
Abstract
Rationale. 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.
The purpose of the study. To evaluate the safety and effectiveness of trifarotene cream, 0.005%, a new topical retinoid, for moderate acne of the face and trunk.
Material and research 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.
Full Text
![Restricted Access](https://rjsvd.com/lib/pkp/templates/images/icons/text_lock.png)
About the authors
Kira Olkhovskaya
Author for correspondence.
Email: olhovskaya_kira@mail.ru
ORCID iD: 0000-0003-4920-5288
Russian Federation
Yuri Perlamutrov
Email: y.perlamutrov@mail.ru
ORCID iD: 0000-0002-4837-8489
Russian Federation
Anton Solovyov
Email: doctorsolovyov@mail.ru
ORCID iD: 0000-0003-3113-8929
References
- Layton AM, Thiboutot D, Tan J. Reviewing the global burden of acne: how could we improve care to reduce the burden? Br J Dermatol. 2020;184(2):219-225. doi: 10.1111/bjd.19477
- Chen H, Zhang TC, Yin XL, Man JY, Yang XR, Lu M. Magnitude and temporal trend of acne vulgaris burden in 204 countries and territories from 1990 to 2019: an analysis from the Global Burden of Disease Study 2019. Br J Dermatol. 2022;186(4):673-683. doi: 10.1111/bjd.20882
- Tan J, Frey MP, Thiboutot D, Layton A, Eady A. Identifying the Impacts of Acne: A Delphi Survey of Patients and Clinicians. J Cutan Med Surg. 2020;24(3):259-266. doi: 10.1177/1203475420907088
- Ottaviani M, Flori E, Mastrofrancesco A, Briganti S, Lora V, Capitanio B, et al. Sebocyte differentiation as a new target for acne therapy: an in vivo experience. J Eur Acad Dermatol Venereol. 2020;34(8):1803-1814. doi: 10.1111/jdv.16252
- Mohsin N, Hernandez LE, Martin MR, Does AV, Nouri K. Acne treatment review and future perspectives. Dermatol Ther. 2022;35(9):e15719. doi: 10.1111/dth.15719
- Dreno B, Dekio I, Baldwin H, Demessant AL, Dagnelie M-A, Khammari A, et al. Acne microbiome: From phyla to phylotypes. J Eur Acad Dermatol Venereol. 2023;00:1-8. doi: 10.1111/jdv.19540
- Dreno B, Gollnick HP, Kang S, Thiboutot D, Bettoli V, Torres V, et al. Understanding innate immunity and inflammation in acne: implications for management. J Eur Acad Dermatol Venereol. 2015;29(4):3-11. doi: 10.1111/jdv.13190
- Tan J, Bourdes V, Bissonnette R, Petit BEL, Reynier P, Khammari A, et al. Prospective Study of Pathogenesis of Atrophic Acne Scars and Role of Macular Erythema. Journal of drugs in dermatology. J Drugs Dermatol. 2017;16(6):566-572.
- Aubert J, Piwnica D, Bertino B, Blanchet-Rethore S, Carlavan I, Deret S, et al. Nonclinical and human pharmacology of the potent and selective topical retinoic acid receptor-gamma agonist trifarotene. Br J Dermatol. 2018;179(2):442-456. doi: 10.1111/bjd.16719
- Balak DMW. Topical trifarotene: a new retinoid. Br J Dermatol. 2018;179(2):231-232. doi: 10.1111/bjd.16733 Schleicher S, Moore A, Rafal E, Gagne-Henley A, Johnson SM, Dhawan S, et al. Trifarotene Reduces Risk for Atrophic Acne Scars: Results from A Phase 4
- Controlled Study. Dermatol Ther (Heidelb). 2023;13(12):3085-3096. doi: 10.1007/s13555-023-01042-7
- Aubert J, Piwnica D, Bertino B, Blanchet-Rethore S, Carlavan I, Deret S, et al. Nonclinical and human pharmacology of the potent and selective topical retinoic acid receptor-gamma agonist trifarotene. Br J Dermatol. 2018;179(2):442-456. doi: 10.1111/bjd.1671
- Nast A, Dreno B, Bettoli V, Bukvic Mokos Z, Degitz K, Dressler C, et al. European evidence-based (S3) guideline for the treatment of acne - update 2016 - short version. J Eur Acad Dermatol Venereol. 2016;30(8):1261-8. doi: 10.1111/jdv.13776
- Blume-Peytavi U, Fowler J, Kemény L, Draelos Z, Cook-Bolden F, Dirschka T, et al. Long-term safety and efficacy of trifarotene 50 μg/g cream, a first-in-class RAR-γ selective topical retinoid, in patients with moderate facial and truncal acne. J Eur Acad Dermatol Venereol. 2020;34(1):166-173. doi: 10.1111/jdv.15794
- Tan J, Thiboutot D, Popp G, Gooderham M, Lynde C, Del Rosso J, et al. Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019;80(6):1691-1699. d oi: 10.1016/j.jaad.2019.02.044
- Del Rosso JQ. Truncal acne vulgaris: the relative roles of topical and systemic antibiotic therapy. J Drugs Dermatol. 2007;6:148-151
- General characteristics of the drug Akliv. Drug registration certificate-No.(001233)-(RG-RU) dated 09/19/2022
Supplementary files
![](/img/style/loading.gif)