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. 2023 Nov 23;10(2):104–122. doi: 10.1159/000534972

Table 3.

Onychomycosis studies

Study Design Therapy Dosage Sample size Patient demographics (age/sex) Nail involvement Outcomes
Alessandrini et al. (2020) [30] Clinical trial Topical vitamin E and essential oils of lime, oregano, and tea tree Topical solution once daily 20 patients Mean age 45 years; 7 female patients and 13 male patients NR At 3 months post-therapy (6 months therapy), 3/17 patients (17.6%) had complete cure (clinical and mycological exam), 13/17 (76.4%) had clinical improvement, and 1/17 patient remained stable (5.8%). At 6 months post-therapy, 7/14 patients (50%) had complete cure, 6/14 (42.8%) had clinical improvement, and 1/14 (7.1%) remained stable. At 6-month follow-up, 11/14 patients had complete cure (78.5%), 2/14 (14.3%) had improvement, and 1/14 (7.1%) remained stable. 4/6 patients dropped out due to patient-reported complete cure of affected nail (2/6 at 3 months; 2/6 at 6 months).
Goldsmith (1983) [31] Case report Topical vitamin E Topical 400 IU vitamin E once daily (contents of a vitamin capsule) 1 patient 37/M Toenails Complete clinical cure after 6 months of treatment. Recurrence occurred in 2 nails and vitamin E application was restarted in nails with recurrence only. At 6-week follow-up, the nails with recurrence had resolved and all other nails remained clinically resolved.
Campione et al. (2015) [32] Clinical trial Topical tazarotene Topical tazarotene 0.1% gel daily 15 patients 14–70 years; 8 female patients and 7 male patients Toenails After 4 weeks, 6/15 (40%) of patients achieved mycological cure. Complete clinical resolution and negative cultures were achieved by 15/15 patients at week 12 (p < 0.04), and patients remained clinically cured at 6-month follow-up. The most common side effect was mild nail fold erythema. Disk diffusion assay after 48 h of incubation in tazarotene solution showed a central area of inhibition in all fungal cultures.
El-Salam et al. (2020) [33] Clinical trial Topical tazarotene Topical tazarotene 0.1% gel daily; topical tazarotene 0.1% gel once daily; and tioconazole nail paint 28% once daily 40 patients 20–40 years Majority fingernails After 3 months, clinical improvement, as assessed by onychomycosis severity index, was 25% in the tazarotene alone group and 50% in the tazarotene and tioconazole group (p = 0.039). Tazarotene was most effective against Aspergillus niger (negative culture achieved in 3/3 patients). Tazarotene and tioconazole were most effective against A. niger (negative culture achieved in 3/4 patients) and Candida species (negative culture achieved in 7/9 patients). Reported side effects included irritation (10% tazarotene group, 25% combination group) and skin peeling (15% tazarotene group, 30% combination group).
Abd El-Aal et al. (2019) [34] Clinical trial Topical tazarotene Fractional carbon dioxide laser (4 sessions) followed by topical tazarotene; fractional carbon dioxide laser (4 sessions) followed by topical tioconazole 28% 102 patients Mean age 33 years; 72 female patients and 30 male patients Majority fingernails No difference between groups, with 35.3% of the tazarotene group showing complete resolution and 33.3% of the tioconazole group showing complete resolution (p = 0.33). In the tazarotene group, 91.7 and 100% had negative KOH test and culture result after treatment, respectively. In the tioconazole group, 78.3 and 95.5% of patients had negative KOH tests and culture results after treatment, respectively (p < 0.001).
Nasr et al. (2022) [35] Clinical trial Oral acitretin Itraconazole pulse therapy (400 mg/day for 1 week/month); oral acitretin (25 mg/day); combined itraconazole/acitretin therapy (itraconazole 400 mg/day for 1 week/month and oral acitretin 25 mg/day) 135 patients 24–63 years; majority female patients Fingernails and toenails Mycological cure and complete cure were achieved by 51.1 and 20% of the itraconazole group, 28.9 and 28.9% of the acitretin group, and 80.0 and 53.3% in the combined itraconazole/acitretin group (mycological cure p ≤ 0.05 and clinical cure p = 0.007). Cheilitis was reported in 44.4% (20/45) of the oral acitretin group and 57.7% (26/45) of the combined itraconazole/acitretin therapy group.