{"id":327790,"date":"2021-10-04T02:00:00","date_gmt":"2021-10-04T00:00:00","guid":{"rendered":"https:\/\/medizinonline.com\/miconazole-nitrate-and-ketaconazole-as-equivalent-topical-therapy-options\/"},"modified":"2021-10-04T02:00:00","modified_gmt":"2021-10-04T00:00:00","slug":"miconazole-nitrate-and-ketaconazole-as-equivalent-topical-therapy-options","status":"publish","type":"post","link":"https:\/\/medizinonline.com\/en\/miconazole-nitrate-and-ketaconazole-as-equivalent-topical-therapy-options\/","title":{"rendered":"Miconazole nitrate and ketaconazole as equivalent topical therapy options."},"content":{"rendered":"

The episodic scaling dermatosis leads to a high degree of suffering. Dermatological shampoos containing antifungal substances have been shown to alleviate symptoms in the capillitium area. In a multicenter study, miconazole nitrate 2% and ketoconazole 2% for the treatment of seborrheic dermatitis of the scalp were found to be comparable in terms of both efficacy and tolerability.<\/strong><\/p>\n

<\/p>\n

Seborrheic eczema is a chronic recurrent inflammatory skin disease characterized by scaling, itching and erythematous plaques. Typical predilection sites include the capillitium and face [1\u20133]. The etiopathogenesis is not yet fully understood; a multifactorial structure is assumed. There is evidence that excessive colonization of the scalp with the yeast Malassezia furfur (Pityrosporum ovale)<\/em> due to increased production of the sebaceous glands plays an important role [2,4,5]. Antifungal therapy leading to a reduction in Malassezia colonization on the scalp has been shown to be an effective method of therapy, azole antifungals in particular have been shown to be effective [3,6].<\/p>\n

Comparative study of topical azole-containing antifungal agents.<\/h2>\n

The aim of a study published in the Journal of Dermatological Treatment <\/em>by Buechner et al. consisted in demonstrating the non-inferiority of miconazole nitrate compared to ketoconazole in the topical treatment of seborrheic dermatitis on the scalp [8]. In the randomized-double-blind multicenter comparative study in a parallel-group design, miconazole nitrate 2% shampoo* vs. ketoconazole 2% shampoo were each applied at a dosage of 10 ml, 2\u00d7 weekly, for a treatment period of 4 weeks (n=145, n=129). The severity of the leading symptoms (erythema, scaling and itching) was operationalized using the “Symptom Scale of Seborrheic Dermatitis” (SSSD). The age range of the subjects was 18-70 years, and the inclusion criteria included a baseline score of at least 6 points on the SSSD scale.<\/p>\n

* Content composition of the shampoo containing miconazole nitrate: 2% miconazole nitrate, 0.75% piroctonolamine, 8% urea.<\/em><\/span><\/p>\n

 <\/p>\n

Primary and secondary efficacy endpoints met<\/h2>\n

The demographic characteristics of the two treatment groups at baseline were similar, including mean age (miconazole group: 42.0 years, ketoconazole group: 42.3 years) [8]. Disease severity at baseline also did not differ significantly between the two treatment groups (mean SSSD score 8.3 vs. 8.1).<\/p>\n

The primary endpoint of the study was the reduction in the Symptom Scale of Seborrheic Dermatitis (SSSD) after a treatment period of 4 weeks. To evaluate this efficacy endpoint, individual change in SSSD score was measured from baseline (day 0, assessment 1) to day 28 (assessment 3). Due to the “non-inferiority” design, data analysis was performed in the PP** study population. The null hypothesis of >1 inferiority in the SSSD score of treatment with miconazole compared with ketoconazole was rejected, with a predefined type 1 error rate of 0.025 in the one-sided t test (Table 1) <\/span>. The treatment effects of the two study arms did not differ significantly. The adjusted difference between the miconazole and ketoconazole groups was 0.21 SSSD score points (95% CI: 0.42-0.85).<\/p>\n

** PP study population= “Per-Protocol” study population.<\/em><\/span><\/p>\n

 <\/p>\n

\"\"<\/p>\n

 <\/p>\n

Conclusion<\/h2>\n

Overall, in the present comparative study, all of the interference statistical analyses show non-inferiority of the miconazole-containing treatment compared with the ketoconazole formulation. Secondary efficacy endpoints, including subscores in the SSSD and CGI*** and proportion of responders$ also proved comparable in both treatment groups, underscoring the equivalence of the two treatment options. Both miconazole and ketoconazole were convincingly well tolerated. Most of the drug-related side effects were mild to moderate and limited to mild burning or itching of the scalp.<\/p>\n

*** CGI = Clinical Global Impression
\n$<\/span><\/sup> <\/em>
\n Responders were defined as subjects who achieved an SSSD score of at least 3.<\/span>
\n<\/em>
\n <\/p>\n

 <\/p>\n

Literature:<\/p>\n

    \n
  1. Aschoff R, Kempter W, Meurer M. [Seborrheic dermatitis]. Dermatologist 2011; 62: 297-307.<\/li>\n
  2. Hay RJ. Malassezia, dandruff and seborrheic dermatitis: an overview. Br J Dermatol 2011; 165: 2-8.<\/li>\n
  3. Naldi L, Rebora A. Clinical practice. Seborrheic dermatitis. N Engl J Med. 2009; 360: 387-396.<\/li>\n
  4. DeAngelis YM, et al: Three etiologic facets of dandruff and seborrheic dermatitis: Malassezia fungi, sebaceous lipids, and individual sensitivity. J Investig Dermatol Symp Proc 2005; 10: 295-297.<\/li>\n
  5. Tajima M, et al: Molecular analysis of Malassezia micro\ufb02ora in seborrheic dermatitis patients: comparison with other diseases and healthy subjects. J Invest Dermatol 2008; 128: 345-351.<\/li>\n
  6. Gupta AK, Nicol K, Batra R: Role of antifungal agents in the treatment of seborrheic dermatitis. Am J Clin Dermatol 2004; 5: 417-422.<\/li>\n
  7. Quatresooz P, et al: Novelties in the multifaceted miconazole effects on skin disorders. Expert Opin Pharmacother 2008; 9: 1927-1934.<\/li>\n
  8. Buechner SA: Multicenter, double-blind, parallel group study investigating the non-inferiority of efficacy and safety of a 2% miconazole nitrate shampoo in comparison with a 2% ketoconazole shampoo in the treatment of seborrheic dermatitis of the scalp. Journal of Dermatological Treatment 2013; Early online 1-6.<\/li>\n<\/ol>\n

     <\/p>\n

    DERMATOLOGY PRACTICE 2021; 31(4): 30<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

    The episodic scaling dermatosis leads to a high degree of suffering. Dermatological shampoos containing antifungal substances have been shown to alleviate symptoms in the capillitium area. In a multicenter study,…<\/p>\n","protected":false},"author":7,"featured_media":110826,"comment_status":"closed","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"pmpro_default_level":"","cat_1_feature_home_top":false,"cat_2_editor_pick":false,"csco_eyebrow_text":"Seborrheic dermatitis ","footnotes":""},"category":[11331,11340,11508,11548,11503],"tags":[16348,13544,19322,16455,19317],"powerkit_post_featured":[],"class_list":["post-327790","post","type-post","status-publish","format-standard","has-post-thumbnail","category-allergology-and-clinical-immunology","category-dermatology-and-venereology","category-education","category-rx-en","category-studies","tag-dermatosis-en","tag-eczema-en","tag-miconazole","tag-shampoo-en","tag-shed","pmpro-has-access"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-05-17 17:59:32","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"wpml_current_locale":"en_US","wpml_translations":{"fr_FR":{"locale":"fr_FR","id":327804,"slug":"le-nitrate-de-miconazole-et-le-ketaconazole-des-options-de-traitement-topique-equivalentes","post_title":"Le nitrate de miconazole et le k\u00e9taconazole, des options de traitement topique \u00e9quivalentes","href":"https:\/\/medizinonline.com\/fr\/le-nitrate-de-miconazole-et-le-ketaconazole-des-options-de-traitement-topique-equivalentes\/"},"it_IT":{"locale":"it_IT","id":327818,"slug":"miconazolo-nitrato-e-ketaconazolo-come-opzioni-terapeutiche-topiche-equivalenti","post_title":"Miconazolo nitrato e ketaconazolo come opzioni terapeutiche topiche equivalenti","href":"https:\/\/medizinonline.com\/it\/miconazolo-nitrato-e-ketaconazolo-come-opzioni-terapeutiche-topiche-equivalenti\/"},"pt_PT":{"locale":"pt_PT","id":327827,"slug":"nitrato-de-miconazol-e-ketaconazol-como-opcoes-de-terapia-topica-equivalente","post_title":"Nitrato de miconazol e ketaconazol como op\u00e7\u00f5es de terapia t\u00f3pica equivalente","href":"https:\/\/medizinonline.com\/pt-pt\/nitrato-de-miconazol-e-ketaconazol-como-opcoes-de-terapia-topica-equivalente\/"},"es_ES":{"locale":"es_ES","id":327829,"slug":"el-nitrato-de-miconazol-y-el-ketaconazol-como-opciones-terapeuticas-topicas-equivalentes","post_title":"El nitrato de miconazol y el ketaconazol como opciones terap\u00e9uticas t\u00f3picas equivalentes","href":"https:\/\/medizinonline.com\/es\/el-nitrato-de-miconazol-y-el-ketaconazol-como-opciones-terapeuticas-topicas-equivalentes\/"}},"_links":{"self":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/327790","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/users\/7"}],"replies":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/comments?post=327790"}],"version-history":[{"count":0,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/posts\/327790\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media\/110826"}],"wp:attachment":[{"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/media?parent=327790"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/category?post=327790"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/tags?post=327790"},{"taxonomy":"powerkit_post_featured","embeddable":true,"href":"https:\/\/medizinonline.com\/en\/wp-json\/wp\/v2\/powerkit_post_featured?post=327790"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}