J Clin Aesthet Dermatol. 2025;18(4):41–43.
by Atsuyuki Igarashi, MD; Masatoshi Abe, MD; Yurie Gunji, BA; Osamu Nemoto, MD; Kuniko Kawamura, MD; Mayumi Yokozeki, MD; Atsushi Saito, MD; and Akira Ookawara, MD
Dr. Igrashi is with Igarashi Dermatology Clinic Higashi Gotanda in Tokyo, Japan. Drs. Abe, Nemoto, Kawamura, Yokozeki, Saito, and Ookawara are with Medical Corporation Kojinkai, in Sapporo, Japan. Ms. Gunji is with L’Oreal Dermatological Beauty Products Division in Tokyo, Japan.
FUNDING: This study was sponsored by L’Oreal Japan.
DISCLOSURES: The authors have served as consultants to L’Oreal Japan.
ABSTRACT: Background: Acne is a common inflammatory dermatosis in all parts of the world, including Japan. While effective prescription treatments are available, patients often prefer to try to manage their acne, particularly when it is mild, using over-the-counter (OTC) approaches. Objective: This open-label study evaluated the efficacy and safety of an OTC serum containing a multi-acid complex and niacinamide (niacinamide 2%, lactic acid 1%, hydroxyethylpiperazine ethane sulfuric acid [HEPES] 0.5%, phytic acid 0.2%, and salicylic acid 0.2%) used twice daily for eight weeks in Japanese women aged 16 to 34 years with acne. Methods: An eight-week, split-face, open-label study of multi-acid complex and niacinamide containing dermocosmetic used twice daily in Japanese women aged 16 to 34 years was conducted. Participants had mild-to-moderate inflammatory acne (up to 20 inflammatory lesions on half the face) and assessments included number and severity of acne lesions as well as standard safety assessments. Results: A total of 50 women enrolled, with 46 eligible for evaluation at Week 8. Significant improvements in acne severity, the number of inflammatory lesions, and skin texture as indicated by pore size were observed (P<0.05 for all). In addition, patients’ quality of life significantly improved from baseline to Week 8 (P<0.01). The serum was well tolerated. Four cases of skin discomfort were reported; all were mild in severity and resolved spontaneously. Conclusion: This multi-acid/niacinamide OTC serum effectively improved acne in Japanese women.
Keywords: Acne vulgaris, Asian skin, Japanese, multi-acid complex, over-the-counter, clinical study
Introduction
Acne vulgaris is a common skin condition among Japanese individuals, including adolescent and young adult women, with 64.8 percent of adolescents reporting acne in a recent epidemiological study by Kubota et al.1 In this population, acne can result in depression, diminished overall mental health, and social difficulties. Several topical and systemic medical treatments are approved for acne in Japan, including topical retinoids, benzoyl peroxide, and antibiotics; however, a high proportion (61.2% in the Kubota study) do not seek treatment.1 In addition, medical therapies such as benzoyl peroxide and topical retinoids can be associated with irritation and patients may elect to discontinue treatment before their acne has cleared.2 For these reasons, many patients seek over-the-counter products with both therapeutic and cosmetic activity (ie, dermocosmetics) that are well tolerated and easily obtainable. Among the most effective anti-acne ingredients are hydroxy acids (HAs), with combinations of multiple HAs exerting a synergistic effect and improved therapeutic outcomes compared to a single HA.3,4 It is thought that these acids have a strong comedolytic effect and may target microcomedones to reduce clinical acne lesions.3 The present study evaluated the efficacy and safety of a multi-acid complex and niacinamide containing dermocosmetic in Japanese women with mild acne vulgaris.
Methods
This was an eight-week, open-label study of multi-acid complex and niacinamide containing dermocosmetic (niacinamide 2%, lactic acid 1%, hydroxyethylpiperazine ethane sulfuric acid [HEPES] 0.5%, phytic acid 0.2%, and salicylic acid 0.2%; La Roche Posay Effaclar® Serum, L’Oreal Japan) used twice daily with moisturizer in Japanese women aged 16 to 34 years. This study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice and was reviewed and approved by the NPO Tactics ethical committee. All patients or guardians provided written informed consent to participate as well as photoconsent.
Eligible patients consulted a physician about facial acne and had up to 20 inflammatory lesions on half of the face; noninflammatory lesions could also be present. Women with more severe acne, including cysts or nodules, were excluded, as were those using any systemic or topical prescription acne medication or other topical facial medications. Additional exclusion criteria included the use of supplements specifically for the improvement of the skin’s appearance, use of steroids or immunosuppressive drugs, use of hormonal replacement therapy, and pregnancy or lactation. Patients were instructed to spread 2 to 3 drops of serum twice daily (morning and evening) after moisturizing. The subjects only used study products during this period.
Assessments were performed at baseline, Week 4, and Week 8 and included number and severity of facial acne lesions and a four-point severity determination of inflammatory lesions on half of the face (0–5 lesions=mild, 6–20 lesions=moderate, 21–50 lesions=severe, >50=very severe), and a five-point scale each for post-inflammatory erythema (PIE) and post-inflammatory hyperpigmentation (PIH) scored 0=absent, 1=1–2 lesions, 2=3–5 lesions, 3=6 –10 lesions, 4=>11 lesions. Cutaneous tolerability was assessed, and adverse events were collected. Finally, investigators visually evaluated pores on a nine-point scale that allowed half-point scores (from 0=none to 4=severe/very noticeable pores) and digital photography was performed. Patient-reported outcomes were assessed by quality of life questionnaire (Cardiff Acne Disability Index [CADI]).
Quantitative variables were analyzed using the per-protocol population; missing values were not imputed and subjects with missing values were excluded from the analysis. Safety analyses also did not impute missing values. Descriptive statistics were analyzed for efficacy assessments, patient questionnaire results, and safety variables. Significance was analyzed by Bonferroni’s multiple comparison test with a significance level of P<0.05. IBM SPSS Statistics 19 (IBM Japan LTD.) and Excel Statistics 2012 (Social Information Service Co., LTD.) were used in significance test.
Results
A total of 50 women participated in the study, of which three dropped out prior to use of study product. One additional patient did not apply the study product for nine days due to COVID-19 infection and was discontinued and 46 women had eight-week evaluations. The mean age of the population was 23.0 ± 6.0 years (range: 16–34 years).
The mean acne severity score was 1.7 at baseline and 1.4 at Week 8 (P<0.05). Inflammatory lesion counts were reduced from 11.2±7.2 at baseline to 8.4±4.9 by Week 8 (P<0.01); non-inflammatory lesions were 7.3±4.7 at baseline and 8.7±5.5 at Week 8 (P=NS); and total lesion counts decreased from 18.5±9.1 to 17.1±6.2 (P=NS). PIE and PIH were not significantly different at baseline and Week 8.
The mean scores for pore evaluation was 3.0±0.8 at baseline and decreased significantly to 1.9±0.7 at Week 8 (P<0.01).In addition, quality of life was significantly improved, as indicated by a reduction of mean CADI score from 4.5±1.9 at baseline to 2.5±2.1 at Week 8 (P<0.01); CADI has been shown to be responsive to change, but the minimal important clinical difference is not known. Figure 1 shows representative patient photos.
Four cases of skin discomfort (irritation, itch, redness, and swelling) occurred during the study; all were judged mild in intensity and resolved without intervention. These were considered to be transient events associated with cosmetics normally used by the patients. Investigator reports indicated patients had no symptoms that were highly worsened. Cutaneous tolerability was excellent overall. A small amount of skin irritation was present at baseline (mean dryness score 0.6, mean desquamation/scaling score 0.4). By Week 8, dryness scores had significantly improved from 0.4±0.6 to 0.1±0.3 (P<0.01). There were no significant changes in other assessments of cutaneous tolerability.
Discussion
According to the results of this study, the evaluated multi-acid complex and niacinamide containing dermocosmetic serum reduced inflammation, had a beneficial impact on acne, and improved the skin appearance as indicated by pore size. It is important for clinicians to be aware of dermocosmetics that are effective in mild forms of acne. In general, acne treatment in Japan is primarily driven by prescription medication use, but the authors acknowledge that contingency plans should be in place for patients who are unable or do not wish to use prescription medication. Such strategies will likely also be useful for patients who have frequent, mild recurrences of acne. The multi-acid complex and niacinamide containing dermocosmetic serum combines hydroxy acids with niacinamide and was formulated for use in milder forms of acne. Using the different acids in combination provides a synergistic effect, including comedolytic actions and potentially reducing microcomedone formation by keeping pores unclogged.3,5–9 As reported by Queille-Roussel et al,3 a triple-acid serum also had a beneficial effect as a maintenance regimen, with 90 percent of patients and 86 percent of dermatologists reporting acne improved during two months of therapy with serum after anti-acne medications.
Limitations. The primary limitation was the open-label design; however, utilization of split-face methodology may have helped to offset that somewhat.
Conclusion
Overall, this study indicates that a multi-acid complex and niacinamide containing acne dermocosmetic serum is effective and well-tolerated, and can improve clinical benefits in the milder forms of acne. This serum should be part of the management protocol for patients with acne-prone skin as a non-medicated alternative.
Acknowledgments
The authors wish to thank Dr. Delphine Kerob, MD, Scientific Director of La Roche-Posay Laboratoire Dermatologique, for her assistance in designing the study, analyzing results, and reviewing the manuscript. The authors also thank Valerie Sanders of Sanders Medical Writing for editorial support.
References
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- Moradi Tuchayi S, Alexander TM, Nadkarni A, et al. Interventions to increase adherence to acne treatment. Patient Prefer Adherence. 2016;10:2091–2096.
- Quielle-Roussel C, LeFloc’h C, Le Dantec G, et al. Ultra-concentrated tri-acid complex serum as maintenance therapy in adult female acne. J Eur Acad Dermatol Venereol. 2023;37(7):e840-e841.
- Ma X, Guo J, Bouffard F, et al. Therapeutic mechanisms of α-/β-hydroxy acid complex on skin sebum balance and acne via network pharmacology. Biochem Mol Biol. 2022;7(2):25–34.
- Khammari A, Demessant-Flavigny A, Kerob D, et al. A salicylic acid-based dermocosmetic is effective as an adjunct to benzoyl peroxide for mild to moderate acne and as monotherapy in maintenance post benzoyl peroxide. J Drugs Dermatol. 2023;22(12):1172–1177.
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- Tanno O, Ota Y, Kitamura N, et al. Nicotinamide increases biosynthesis of ceramides as well as other stratum corneum lipids to improve the epidermal permeability barrier. Br J Dermatol. 2000;143(3):524–531.
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