Efficacy of combination therapy with ethylmethylhydroxypyridine malate and aminophenylbutyric acid in patients with papulopustular rosacea

Ayupova K.R., Yusupova L.A.

Kazan State Medical Academy – Branch of the Russian Medical Academy of Continuous Professional Education, Kazan, Russia

Background: Rosacea is a chronic, recurring, inflammatory skin disease of the face, in whose pathogenesis oxidative stress, neurogenic-vascular dysregulation, and psychosomatic disorders play a key role.
Objective: Evaluation of the clinical efficacy of combination therapy with ethylmethylhydroxypyridine malate and aminophenylbutyric acid (EmAa) in patients with papulopustular rosacea (PPR) based on the dynamics of the RDS and IGA indices, and determination of the impact of therapy on quality of life, anxiety levels, sleep parameters, and the antioxidant system.
Materials and methods: Forty-nine patients with PPR were examined and randomized into two groups: Group 1 (n=25) received traditional therapy (doxycycline 100 mg/day orally and 15% azelaic acid gel topically twice a day); Group 2 (n=24) received traditional therapy in combination with EmAa (ethyl methylhydroxypyridine malate 100 mg and aminophenylbutyric acid 250 mg orally 3 times a day for 4 weeks). The control group consisted of 20 healthy individuals. Primary efficacy criteria: the RDS index and the IGA scale; secondary ones: DLQI, PSQI, HARS, biochemical markers of the antioxidant system (LPO, SOD, HO, NRF2). 
Results: Therapy including EmAa provided significantly higher clinical efficacy: the RDS index decreased from 13.92±1.346 to 1.61±1.198 points, IGA – by 3.8 times (p<0.001). Against the background of achieving remission, a significant improvement in quality of life was noted (DLQI decreased by 4.2 times), normalization of sleep architecture (PSQI from 9.19±1.029 to 3.75±0.946 points) and a reduction in anxiety according to the HARS scale (from 24.03±0.145 to 5.29±0.137 points). Biochemical monitoring revealed a decrease in the LPO level to control values, restoration of SOD and HO activity, and normalization of NRF2 concentration (p<0.001). 
Conclusion: Combination therapy with EmAa demonstrated high clinical efficacy in PPR, providing sustained remission. The achieved clinical results were accompanied by restoration of quality of life, normalization of psychosomatic status, and correction of oxidative stress, which pathogenetically justifies the inclusion of these medications in the treatment regimen for patients with papulopustular rosacea.

For citations: Ayupova K.R., Yusupova L.A. Efficacy of combination therapy with ethylmethylhydroxypyridine malate and aminophenylbutyric acid in patients with papulopustular rosacea. Pharmateca. 2026;33(5):122-129. (In Russ.). DOI: https://dx.doi.org/10.18565/pharmateca.2026.5.122-129

Authors’ contribution: All authors made an equivalent contribution to the preparation of the publication.
Conflicts of interest: The authors confirm that they have no conflicts of interest to declare.
Funding: The study was conducted without any sponsorship.
Ethical Approval: The study was approved by the ethics committee.
Patient Consent for Publication: All patients provided informed consent for the publication of their data.
Authors’ Data Sharing Statement: The data supporting the findings of this study are available upon request from the corresponding author after approval from the principal investigator.
Дополнительная информация: This work was conducted as part of a dissertation: «Clinical and pathogenetic approaches to improving the effectiveness of therapy for patients with papulopustular rosacea».

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About the Authors

Kamila R. Ayupova, Applicant at the Department of Dermatovenereology and Cosmetology, Kazan State Medical Academy –Branch of the Russian Medical Academy of Continuous Professional Education, Kazan, Russia; skinderma@rambler.ru, ORCID: https://orcid.org/0000-0002-2179-1214, eLibrary SPIN: 3811-5710 (corresponding author)
Luiza A. Yusupova, Dr. Sci. (Med.), Professor, Head of the Department of Dermatovenereology and Cosmetology, Kazan State Medical Academy – Branch of the Russian Medical Academy of Continuous Professional Education. Kazan, Russia; yuluizadoc@hotmail.com, ORCID:
https://orcid.org/0000-0001-8937-2158, eLibrary SPIN: 5743-6872

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