Clinical and Instrumental Evaluation of a New Topical Non-Corticosteroid
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Journal name: Clinical, Cosmetic and Investigational Dermatology Article Designation: Original Research Year: 2019 Volume: 12 Clinical, Cosmetic and Investigational Dermatology Dovepress Running head verso: Dall’Oglio et al Running head recto: Dall’Oglio et al open access to scientific and medical research DOI: http://dx.doi.org/10.2147/CCID.S186621 Open Access Full Text Article ORIGINAL RESEARCH Clinical and instrumental evaluation of a new topical non-corticosteroid antifungal/anti- inflammatory/antiseborrheic combination cream for the treatment of mild-to-moderate facial seborrheic dermatitis Federica Dall’Oglio1 Purpose: Topical agents play a key role in the management of facial seborrheic dermatitis Francesco Lacarrubba1 (SD) by reducing inflammation and scale production. The aim of this open-label trial was to Maria Luca1 assess the efficacy and tolerability of a new non-corticosteroid, antifungal/anti-inflammatory/ Simona Boscaglia1 antiseborrheic cream containing piroctone olamine, stearyl glycyrrhetinate, and zinc PCA in 2 the treatment of facial SD using clinical and instrumental evaluation. For personal use only. Corinne Granger Twenty adult subjects affected by mild-to-moderate inflamed facial Giuseppe Micali1 Patients and methods: SD were enrolled and instructed to apply the study cream twice daily for 60 days. Efficacy 1 Dermatology Clinic, University of was evaluated at baseline, and at days 15, 30, and 60 by measuring the grade of desquama- Catania, Catania, Italy; 2Innovation and Development, ISDIN SA, Barcelona, tion, erythema, and pruritus using clinical evaluation, erythema-directed digital photography, Spain colorimetry, and subject-completed Visual Analog Scale. Additionally, an Investigator Global Assessment (IGA) was assessed using a 5-point scale: excellent response (>80% improvement); good response (50%–80% improvement); mild response (<50% improvement); no response (no change); worsening. Results: After 15 days, a statistically significant decrease from baseline was found in desquama- tion, erythema, colorimetric scores, and pruritus. At day 60, a significant further improvement for all evaluated parameters was recorded. Moreover, the IGA improved in 90% of patients, with an excellent response in 53% of cases. A good correlation was found between clinical and instrumental evaluations. Clinical, Cosmetic and Investigational Dermatology downloaded from https://www.dovepress.com/ by 54.70.40.11 on 13-Jan-2020 Conclusion: Our results indicate that the study facial cream represents an option to consider when dealing with mild-to-moderate SD, being effective, well-tolerated, and free of significant side effects, as confirmed by clinical and instrumental evaluation. Keywords: seborrheic dermatitis, topical cosmetic, digital photography, colorimeter Introduction Correspondence: Giuseppe Micali Facial seborrheic dermatitis (SD) is a common, chronic, recurrent inflammatory dis- Dermatology Clinic, University of ease clinically characterized by erythema, scaling, and pruritus on sebum-rich areas, Catania, A.O.U. Policlinico -Vittorio including the nasolabial folds, malar regions, glabella, and eyebrows. The external Emanuele, Via Santa Sofia, 78 - 95123 Catania, Italy auditory meatus and the retroauricular areas can also be affected.1–5 Tel +39 095 321 705 The pathogenesis of SD is still unclear, but it seems to be multifactorial, involv- Fax +39 095 378 2425 Email [email protected] ing sebaceous gland function, presence on the skin of yeasts belonging to the submit your manuscript | www.dovepress.com Clinical, Cosmetic and Investigational Dermatology 2019:12 103–108 103 Dovepress © 2019 Dall’Oglio et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms. php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work http://dx.doi.org/10.2147/CCID.S186621 you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). Powered by TCPDF (www.tcpdf.org) 1 / 1 Dall’Oglio et al Dovepress Malassezia (M.) spp. (formerly called Pityrosporum ovale), 60 days. The study was performed in accordance with the and the individual immune response.6–8 ethical principles originating from the Declaration of Helsinki Additional precipitating factors include drug intake (lith- 1996 and Good Clinical Practices. The protocol was approved ium, haloperidol, buspirone, chlorpromazine, methyldopa, by the institutional review board of AOU Policlinico “Vittorio cimetidine), nutritional deficiency (acrodermatitis entero- Emanuele” Hospital, Catania. Written informed consent was pathica due to zinc deficiency), neurological and degenerative obtained from each patient before study procedures were disorders (Parkinson’s disease), immunosuppression (HIV started, which included consent to use their images. and non-HIV related), genetic disorders (trisomy 21), as well as environmental factors (cold, low humidity, excessive sun Inclusion/exclusion criteria exposure), physical and psychological stress, and unhealthy Inclusion criteria included a wash-out period of at least 2 lifestyle (alcohol consumption).1,2 weeks for topical antimycotic/corticosteroid treatments, and The therapeutic approach should be selected according 1 month for oral antifungals/corticosteroids or hormonal to SD severity and the patient’s immune status and compli- therapy. Exclusion criteria were: severe underlying disease, ance. For mild-to-moderate facial SD, topical drugs play a concurrent exposure to sunlight and/or artificial ultraviolet key role in the management by reducing erythema and scale sources, pregnancy, and breastfeeding. No other topical production. These include corticosteroids and antifungals.9–14 products or drugs were allowed, except for standard daily The clinical efficacy of current therapeutic agents is widely care products, including mild cleansers, noncomedogenic demonstrated,9–11 although their prolonged use may cause moisturizers, make-up, and SPF 50+ sunscreens. some adverse effects, including skin atrophy, striae, telangi- ectasia, folliculitis, hypopigmentation, and tachyphylaxis in Methodology the case of corticosteroids, irritant contact dermatitis from Patients were instructed to apply the non-corticosteroid facial the use of antifungals, and limitations due to the off-label cream containing piroctone olamine, stearyl glycyrrhetinate use of metronidazole, benzoyl peroxide, lithium succinate/ and zinc PCA, twice daily (at morning and at bedtime) for For personal use only. lithium gluconate, pimecrolimus, and tacrolimus. 8 weeks. In order to reduce potential evaluator bias, all sub- The therapeutic efficacy of topical treatments is gener- jects were assessed by an investigator not directly involved ally based on clinical evaluation of erythema and/or scaling in the study at baseline (T0), and at day 15 (T1), 30 (T2), severity. Erythema-directed digital photography and colo- and 60 (T3). rimetry are noninvasive instrumental techniques that help determine treatment outcome more precisely than simple Study endpoints clinical inspection or standard photography, providing a more The primary end point was efficacy evaluation at day 15 (T1), accurate evaluation of erythema severity.15–21 30 (T2), and 60 (T3) of all clinical parameters (erythema, The aim of this open-label trial was to assess the effi- desquamation, and pruritus) including global assessment; cacy and tolerability of a new topical non-corticosteroid, the secondary endpoint was the evaluation of tolerability and antifungal/anti-inflammatory/antiseborrheic facial cream cosmetic acceptability. in the treatment of mild-to-moderate SD by clinical assess- Clinical, Cosmetic and Investigational Dermatology downloaded from https://www.dovepress.com/ by 54.70.40.11 on 13-Jan-2020 ment and by erythema-directed photography and colorimetry Clinical and instrumental evaluation evaluation. criteria All clinical and instrumental evaluations were carried out at Patients and methods T0, T1, T2, and T3. Study design Desquamation was rated by clinical evaluation using a This was an open-label, prospective clinical trial. 5-point scale: 4 = severe (many large adherent white flakes); 3 = moderate (several small loose white flakes); 2= mild (few Setting and study period small loose white flakes); 1= very mild (very few small loose From September 2017 to March 2018 a total of 20 adult white flakes); 0= no desquamation. subjects (15M/5F; age range 19–55 years) affected by mild- Erythema was evaluated using: 1) VISIA-CR imaging to-moderate facial SD were enrolled at the Department of system equipped with RBX technology (Canfield, Parsippany, Dermatology of the University of Catania. Study duration was NJ, USA), to provide digital images of the face highlighting 104 submit your manuscript | www.dovepress.com Clinical, Cosmetic and Investigational Dermatology 2019:12 Dovepress Powered by TCPDF (www.tcpdf.org) 1 / 1 Dovepress Dall’Oglio et al red areas corresponding to erythema/inflammatory lesions, cases) completed the study, and three subjects were lost to scored on a 5-point scale (4 = severe erythema; 3 = moderate follow-up for personal reasons. erythema; 2 =