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Ktz4.0

Ketoconazole (Nizoral) – Forschung

Überwiegend Mechanismus / Beobachtung

6 begutachtete Studien

Was die Evidenz sagt

Überwiegend Mechanismus / Beobachtung

Die meisten Studien zu Ketoconazole (Nizoral) sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.

Die meiste Evidenz stammt aus mittelwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 1998–2015.

Basierend auf 6 Studien · 1 Meta-Analyse · 1 RCT

Konfidenz

Mittlere Konfidenz

Nach Outcome

Seborrheic dermatitis & dandruff
Überwiegend Mechanismus / Beobachtung3 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung3 Studien
Hair & scalp
Zu wenige bewertete Studien2 Studien
Liver health
Zu wenige bewertete Studien2 Studien
Therapeutic & clinical
Zu wenige bewertete Studien1 Studie

Ältere Forschungsbasis

Neueste Studie von 2015 · Neueste Meta-Analyse: 2013

199820062015

1Systematische Übersicht2015

Ketoconazole and ciclopirox are more effective than placebo for seborrhoeic dermatitis, with fewer symptoms persisting after treatment.

Okokon, Verbeek, Ruotsalainen, Ojo, Bakhoya · Cochrane Database of Systematic Reviews (2015)

Cochrane systematic review of 51 studies (9,052 participants) of topical antifungals for seborrhoeic dermatitis
Topical ketoconazole was more effective than placebo at clearing seborrhoeic dermatitis
Adverse events were generally mild and similar to placebo for topical use

Quelle ansehen

2RCT2007

Once-daily ketoconazole gel 2% was significantly more effective than vehicle for moderate to severe seborrheic dermatitis.

Swinyer, Decroix, Langner, Quiring, Blockhuys · Cutis (2007)

Three randomized, double-blind, vehicle-controlled phase 3 studies in over 900 subjects
Once-daily ketoconazole gel 2% produced significantly more effectively-treated subjects than vehicle (P < .001)
Confirmed topical ketoconazole's efficacy in moderate-to-severe seborrheic dermatitis

3Meta-Analyse2013

Ketoconazole-associated hepatotoxicity was common, and off-label use was associated with a higher incidence — highlighting the systemic liver risk.

Yan, Nie, Tao, Zhan, Zhang · Biomedical and Environmental Sciences (2013)

Systematic review and meta-analysis of 204 eligible studies of ketoconazole-associated hepatotoxicity
Liver injury was a common adverse effect with systemic (oral) ketoconazole
Off-label and higher-dose use carried elevated hepatotoxicity risk

Quelle ansehen

4Übersicht2015

Post-marketing reports of drug-related hepatotoxicity, endocrine dysregulation and drug interactions resulted in market withdrawal of oral ketoconazole in some countries and strict relabeling in others.

Gupta, Daigle, Foley · Expert Opinion on Drug Safety (2015)

Drug-safety review of oral ketoconazole, the first FDA-approved broad-spectrum oral antifungal (1981)
Summarizes hepatotoxicity, adrenal/endocrine dysregulation, and serious CYP3A4 drug interactions
These risks drove the 2013 FDA/EMA restriction of systemic ketoconazole

Quelle ansehen

5Beobachtungsstudie1998

Hair density and size and proportion of anagen follicles were improved almost similarly by both KCZ and minoxidil regimens ... there may be a significant action of KCZ upon the course of androgenic alopecia.

Piérard-Franchimont, De Doncker, Cauwenbergh, Piérard · Dermatology (1998)

Compared 2% ketoconazole shampoo with an unmedicated shampoo, with or without 2% minoxidil, in androgenic alopecia (no randomization stated)
Ketoconazole improved hair density, hair size, and the proportion of anagen follicles — almost similarly to the minoxidil regimen
Supports a Malassezia-driven inflammatory contribution to pattern hair loss that ketoconazole dampens

Quelle ansehen

6Open-Label2002

In an open, randomized study, hair growth was observed in all groups; the best results came from finasteride plus minoxidil, with finasteride-containing groups (including finasteride plus topical ketoconazole) showing statistically significant improvement (p<0.05).

Khandpur, Suman, Reddy · The Journal of Dermatology (2002)

Open, randomized, parallel-group study of 100 men with androgenetic alopecia
Compared oral finasteride, topical 2% minoxidil, and topical 2% ketoconazole shampoo, alone and in combination
Hair growth occurred in all groups; ketoconazole was used as an adjunct rather than a stand-alone treatment

Quelle ansehen

In der Forschungsbibliothek ansehen

Ketoconazole (Nizoral) – Forschung

Überwiegend Mechanismus / Beobachtung

Topical antifungals for seborrhoeic dermatitis.

Ketoconazole gel 2% in the treatment of moderate to severe seborrheic dermatitis.

Ketoconazole associated hepatotoxicity: a systematic review and meta-analysis.

Drug safety assessment of oral formulations of ketoconazole.

Ketoconazole shampoo: effect of long-term use in androgenic alopecia.

Comparative efficacy of various treatment regimens for androgenetic alopecia in men.