A Pilot Study on the Comparative Efficacy and Tolerability of a Novel Dermo-cosmetic Cream with 15% Azelaic Acid for Mild to Moderate Acne: A New Approach to Acne Treatment.
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Abstract
Introduction: Acne is a one of the most frequent skin conditions among teenagers and young adults. It is currently managed with topical retinoids and antibiotics, which can present numerous side effects, thus reducing treatment adherence and effectiveness. We evaluated the efficacy and tolerability of a novel dermo-cosmetic cream (α-AZ) in treating mild to moderate acne.
Methods: Subjects were randomized into three groups: group 1 received α-AZ cream, group 2 was treated with α-AZ combined with an oral acne treatment routine, and group 3 received a topical acne treatment, for 84 days. All treated patients underwent a 28-day maintenance period with α-AZ cream. Total acne and post-inflammatory hyperpigmentation (PIH) scoring, quality of life (QoL), and skin tolerance were all evaluated during the treatment and maintenance periods.
Results: Acne and PIH lesions significantly decreased in group 1 compared to group 3 (p < 0.001), with a reduction in acne of 66.52 ± 2.92% in group 1 versus 52.55 ± 3.90% in group 3. Patients in group 1 achieved nearly clear skin by the end of the treatment. α-AZ cream treatment was well tolerated and all participants experienced an enhanced QoL. Participants expressed high satisfaction. Additional enhancements in all groups were noted during the maintenance phase across all clinical parameters.
Conclusion: The novel dermo-cosmetic α-AZ cream could serve as a valuable new approach to current treatments for mild and moderate acne. It can be used alone, as a once-daily adjuvant to oral acne treatments, or as part of a maintenance regimen.
Trial registration: ISRCTN registry, ISRCTN70142596, registered retrospectively on 11/12/2023.
期刊介绍：
Dermatology and Therapy is an international, open access, peer-reviewed, rapid publication journal (peer review in 2 weeks, published 3–4 weeks from acceptance). The journal is dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of dermatological therapies. Studies relating to diagnosis, pharmacoeconomics, public health and epidemiology, quality of life, and patient care, management, and education are also encouraged.
Areas of focus include, but are not limited to all clinical aspects of dermatology, such as skin pharmacology; skin development and aging; prevention, diagnosis, and management of skin disorders and melanomas; research into dermal structures and pathology; and all areas of aesthetic dermatology, including skin maintenance, dermatological surgery, and lasers.
The journal is of interest to a broad audience of pharmaceutical and healthcare professionals and publishes original research, reviews, case reports/case series, trial protocols, and short communications. Dermatology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an International and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of quality research, which may be considered of insufficient interest by other journals. The journal appeals to a global audience and receives submissions from all over the world.
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