Efficacy

How To Cure Ringworm Now

Fast Ringworm Cure Ebook By William Oliver

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I found no systematic reviews but five RCTs comparing terbinafine with other oral antifungals in tinea capitis (Table 34.1).

Versus griseofulvin

I found four RCTs. A double-blind RCT2327 compared 140 children from Pakistan, 87% of whom had T. violaceum infection. They were treated with either terbinafine 62-5-250 mg/day by weight for 4 weeks, or with griseofulvin, 125-500 mg/day according to patient's weight, for 8 weeks. Four weeks after the conclusion of the study 93% of the terbinafine group were completely cured, compared with 80% in the griseofulvin group, a statistically non-significant difference. A double-blind RCT study24 30 evaluated 50 children from Lima, Peru, 74% of whom had T. tonsurans infection. Half received terbinafine, 62-5-250 mg/day for 4 weeks, the other half griseofulvin, 125-500 mg/day for 8 weeks; dosage was according to body weight. At the end of week 8, 76% of the terbinafine group and 80% of the griseofulvin group showed complete cure. However, 4 weeks later the 76% cure rate in the terbinafine group was sustained, whereas in the griseofulvin group the cure rate had decreased to 44%. An RCT26 compared ultramicrosized griseofulvin for 8 weeks with terbinafine for 4 weeks, both dosed according to body weight. At the final follow up visit at week 12, 88% of the terbinafine-treated group was mycologically cured, compared with 91% of the griseofulvin-treated group; complete cure was reported in 78% and 74% of patients, respectively. Trichophyton spp. and M. canis responded similarly to terbinafine. A large RCT25 compared griseofulvin suspension 10 mg/kg/day for 8 weeks with terbinafine for 4 weeks. T. tonsurans infection accounted for 65% of the terbinafine group and 73% of the griseofulvin group; 14% of each group had Microsporum spp. infection. At week 24, 4 weeks of terbinafine (complete cure rate: 64%) was at least as effective as 8 weeks of griseofulvin (complete cure rate: 67%). However, the Microsporum spp. infections tended to do better with 8 weeks of griseofulvin than with 4 weeks of terbinafine.

Versus itraconazole

One RCT32 compared 2-week courses of terbinafine, 62-5-250 mg, and itraconazole, 50-200 mg (both according to weight). Twelve weeks after the start of treatment, 78% and 86% patients were completely cured in the terbinafine and itraconazole groups, respectively. T. violaceum was the major pathogen in both groups, and there were no Microsporum spp. infections.

Different terbinafine regimens compared

I found four RCTs (Table 34.1). One RCT33 compared 1, 2 and 4 weeks of terbinafine therapy, 62-5-250 mg according to weight. The cure rate was 74% after 1 week of therapy, 80% after 2 weeks and 86% after 4 weeks. However, this study included no griseofulvin control group; 71% of patients had T. violaceum infections. A second RCT34 compared 1, 2 and 4 weeks of terbinafine, 62-5-250 mg according to weight, in 79 children and three adults with T. tonsurans and M. ferruginieum tinea capitis. At week 12, the complete cure rate was 33-3% in the 1-week therapy group, 42-9% in the 2-week therapy group and 63% in the 4-week group. An RCT35 published in two additional abstracts,36,37 compared 1 and 2 weeks of terbinafine, 62-5-250 mg according to weight. At week 12 of follow up, in Trichophyton spp. infections the complete cure rate was 56% with 1 week of therapy and 86% with 2 weeks, but acceptable cure rates in M. canis infection were achieved only after an additional 4 weeks of treatment. An

Study

Trial design, sample size,

Interventions

Time of follow up, quality

Outcome measures

study population and

of reporting, dropouts

Adverse effects

types of fungus Isolated

and comments

Tanz et al. 1985"

Double-blind, randomised.

Griseofulvin tablet,

Follow up: 6 weeks

Mycological cure rates: griseofulvin group: 57-1% (4/7);

USA (Chicago)

22 children 2-16 years old

500 mg/day, plus

Described as randomised

ketoconazole group: 57-1% (4/7)

Griseofulvin group:

"ketoconazole" placebo tablet

Some description of method of

Clinical cure: In both groups, total severity score decreased

T. tonsurans 57-8% (7/12).

(patients <40 kg: half tablet)

blinding, no ITT analysis

similarly during the course of the study

Ketoconazole group:

for 6 weeks n = 12

Dropouts: 5 In griseofulvin

Complete cure: not reported

T. tonsurans 40% (4/10);

Ketoconazole tablet,

group and 3 In ketoconazole

Adverse effects: 0 In griseofulvin group; ketoconazole group:

Pénicillium spp. 10% (1/10);

200 mg/day, plus

group did not complete the

2 mild abdominal pain, 1 urticaria (concomitantly receiving

Scopulariopsis spp 10%

"griseofulvin" placebo tablet

study

penicillin)

(1/10); unidentified fungus

(patients weighting <40 kg:

Compliance assessed

10% (1/10)

half tablet) for 6 weeks n = 10

Supported by Janssen

Co-treatment: antlseborrhoeic

(ketoconazole)

shampoo

Gan et al. 198721

Unknown blinding,

Griseofulvin tablet or

Follow up: 26 weeks

Mycological cure rates at week 12: griseofulvin group: 96%;

USA (Dallas)

randomised

suspension, 15 mg/kg/day,

Method of randomisation: table

1 reversion to negative between 12 and 26 weeks;

80 children 2-1-11 years old

single dally dose; 2-6 weeks

of random numbers

ketoconazole group: 74%; 6 reversions to negative between

T. tonsurans 70% (42/60);

depending on the patient's

No mention of blinding

12 and 26 weeks

M. canis 11 -6% (7/60);

clinical response to

No ITT analysis

Clinical cure: not reported

T. mentagrophytes 1 -6%

therapy n = 40

Dropouts: 11 of griseofulvin

Complete cure rates at week 8: 92% In griseofulvin group;

(1/60); T. violaceum 1-6%

Ketoconazole tablet or

group and 6 of ketoconazole

59% In ketoconazole group

(1/60); uncertain classification

crushed tablets suspended In

group failed to keep

None reported

15% (9/60)

sucrose syrup, 5 mg/kg/day,

follow up visits

single daily dose 2-6 weeks

Compliance assessed

depending on the patient's

No mention of Industry funding

clinical response to

therapy n = 40

No co-treatment

Study

Trial design, sample size,

Interventions

Time of follow up, quality

Outcome measures

study population and

of reporting, dropouts

Adverse effects

types of fungus Isolated

and comments

Tanz et al. 198813

Double-blind, randomised

Griseofulvin (mlcrosize)

Follow up: 12 weeks

Mycologlcal cure rates at week 12: griseofulvin group: 96%;

USA (Chicago)

48 children 2-16 years old

250 mg tablet (10-20 mg/kg/

Method of randomisation:

ketoconazole group: 89%

T. tonsurans (64%)

day) plus "ketoconazole"

coded list, clear description of

Clinical cure at week 12: Patients In both treatment groups

M. canis (12%)

placebo tablet, single dally

method of blinding

showed significant Improvement in their severity score with

dose, for 12 weeks n = 26

No ITT analysis

no statistically significant differences

Ketoconazole 200 mg tablet

Dropouts: 7 of ketoconazole

Complete cure rates at weeks 12: griseofulvin group: 95.15%;

(3.3-6.6 mg/kg/day) plus

group; 16 of griseofulvin group

ketoconazole group: 72-72%

"griseofulvin" placebo tablet

failed to return for follow up

Adverse effects: griseofulvin group: none reported ;

In a single daily dose for 12

visit

ketoconazole group: 1 with nausea

weeks n = 22

Compliance not assessed

Co-treatment: antiseborrhoelc

Supported by Janssen

shampoos

(ketoconazole)

Martinez-Roig et al.

Double-blind, randomised

Griseofulvin tablet,

Follow up: 6 weeks

Mycological cure rates: not reported

198820 Spain

47 children 2-16 years old

350 mg/day, at 12-hourly

Method of randomisation:

Clinical cure rates at week 6: griseofulvin group: 80% (4/5)

(Barcelona)

with tinea but only 13 affected

intervals for 6 weeks n = 5

computer-generated random

Improved; 20% (1/5) deteriorated; ketoconazole group: 100%

by tinea capitis, all with the

Ketoconazole tablet,

number table

(8/8) improved

inflammatory type

100 mg/day at 12-hourly

Described as double blind

Other outcomes: Mean time to clinical cure (weeks):

Ketoconazole group:

intervals for 6 weeks n = 8

No ITT analysis

griseofulvin group: 5; ketoconazole group: 4-2; mean time to

T. mentagrophytes, M. canis,

Co-treatment: manual

Dropouts: none In patients with

negative culture (weeks): griseofulvin group 4-7; ketoconazole

E. floccossum (no distinction

depllatlon In cases of

tinea capitis

group 3-6

between tinea capitis and

inflammatory tinea capitis

Compliance assessed

Complete cure: not reported

tinea corporis)

Supported by Laboratories Dr

Adverse effects: griseofulvin group: one patient with

Griseofulvin group:

Esteve (ketoconazole)

reversible two fold increase In serum alanine

T. mentagrophytes, M. canis,

aminotransferase and aspartate aminotransferase after 3

M. gypseum (no distinction

weeks' treatment; ketoconazole group: none reported

between tinea capitis and tinea

corporis)

Study

Trial design, sample size,

Interventions

Time of follow up, quality

Outcome measures

study population and

of reporting, dropouts

Adverse effects

types of fungus Isolated

and comments

Alvi et al. 199325

Double-blind, randomised

Griseofulvin capsules,

Follow up: 12 weeks.

Mycological cure rates at weeks 12: griseofulvin group:

Pakistan (Karachi,

140 subjects 2-65 years (90%

10-20 kg: 125 mg/day;

Described as randomised

87-75% (43/49); terbinafine group: 92-86% (52/56)

Lahore)

children <12 years old)

20^0 kg: 250 mg/day;

Described as double blind

Clinical cure scores at week 12: griseofulvin group: 0-76;

Duplicate publication

Griseofulvin group:

>40 kg: 500 mg/day) once

No ITT analysis

terbinafine group: 0-46 (where 0 = absent; 1 = mild; 2 =

Haroon et al. 199527

T. violaceurn 89-8% (44/49);

daily for 8 weeks n = 68

Dropouts: 16 patients from the

moderate; 3 = severe)

Pakistan (Lahore,

T. verrucosum 8-2% (4/49);

Terbinafine capsules,

terbinafine group and 19

Complete cure rates at week 12: griseofulvin group: 79-59%

Karachi)

T. tonsurans 2% (1/49)

10-20 kg: 62-5 mg/day;

patients from grlseofulvlne

(39/49); terbinafine group: 92-86% (52/56)

Terbinafine group:

20^0 kg: 125 mg/day; >40

group withdrawn because of

Adverse effects: mostly of uncertain relationship and/or of no

T. violaceurn 86% (48/56);

kg: 250 mg/day) once dally

Irregularities In follow up

relationship to drugs; griseofulvin group: 1 cutaneous

T. verrucosum 5-3% (3/56);

for 4 weeks plus 4 weeks of

No mention of compliance

Infection; 1 cutaneous Infestation; 1 raised hepatic enzymes; 5

T. tonsurans 5-3% (3/56);

placebo n = 72

assessments. Supported by

raised triglycerides; 1 raised uric acid; 1 eoslnophilia; 1

T. rubrum 5-3% (1/5);

No co-treatment

Sandoz (terbinafine)

leucocytosis; 1 granulocytopenia; terbinafine group: 1

M. audouinii 5-3% (1/56)

tonsillitis; 1 cutaneous Infestation; 2 raised hepatic enzymes;

1 raised triglycerides; 3 eoslnophilia

Memlsoglu etal.

Double-blind, randomised,

Griseofulvin (ultramicroslzed),

Follow up: 12 weeks

Mycological cure rates at week 12: griseofulvin group: 91-4%

199926

parallel group

10-20 kg: 125 mg/day;

Described as randomised

(32/35); terbinafine group: 87-5% (28/32)

Turkey (Adana, Izmir,

78 children 2-13 years old

20^0 kg: 250 mg/day;

Described as double blind

Clinical cure scores at week 12: griseofulvin group: 1-2;

Ankara)

Griseofulvin group:

>40 kg: 500 mg/day) for

No ITT analysis

terbinafine group: 1-2; clinical signs and symptoms, Including

T. violaceurn 11-4% (4/35);

8 weeks n = 39

Dropouts: 7 In terbinafine

erythema, oedema, pruritus, hair loss and desquamation

T. rubrum 22-8% (8/35);

Terbinafine, 10-20 kg:

group and 4 In griseofulvin

scored on a scale where 0 = none, 1 = mild, 2 = moderate,

M. canis 48-5% (17/35);

62-5 mg/day; 20-40 kg:

group

3 = severe

T. tonsurans 5-7% (2/35);

125 mg/day; >40 kg:

No mention of compliance

Complete cure rates at week 12: griseofulvin group: M. canis

T. mentagrophytes 5-7% (2/35);

250 mg/day) for 4 weeks plus

assessment

71% (12/17); Trichophyton spp. 78% (14/18); terbinafine

T. verrucosum 5-7% (2/35)

4 weeks of placebo n = 39

No mention of Industry support

group: M. canis 87% (13/15); Trichophyton spp. 73% (11/15)

Terbinafine group:

No co-treatment

Adverse effects: griseofulvin group: 1 elevated aspartate

T. violaceurn 15-6% (5/32);

aminotransferase; 1 elevated triglycerides; 2 anaemia (of

7". rubrum 15-6% (5/32);

uncertain drug relatioshlp); terbinafine group: 1 mild elevated

M. canis 46-8% (15/32);

triglycerides (of uncertain drug relationship)

Table 34.1 (Continued)

Study Trial design, sample size,

Interventions

Time of follow up, quality

Outcome measures

study population and

of reporting, dropouts

Adverse effects

types of fungus Isolated

and comments

T. tonsurans 6-25% (2/32); T. mentagrophytes 3-1% (1/32);

T. tonsurans 6-25% (2/32); T. mentagrophytes 3-1% (1/32);

T. verrucosum 3-1% (1/32); M. audouinii 3-1% (1/32); unidentified 6-25% (2/32)

Cäceres-Rlos et al.

Double-blind, randomised

Griseofulvin (microslzed)

Follow up: 12 weeks

Mycological cure rates at week 12: griseofulvin group: 44%;

200024 Peru (Lima)

50 children 1-14 years old

tablet, 10-20kg; 125mg/day;

Described as "alternately

terbinafine group: 76%

See abstract50

with non-Inflammatory tinea

20-40kg: 250 mg/day;

randomised"

Clinical cure at week 12: Statistically significant differences

capitis

>40 kg:500 mg/day, once a

Described as double blind

between treatment groups at end of week 12

Grlseofulvin group:

day for 8 weeks n = 25

No ITT analysis

Complete cure rates at week 12: griseofulvin group: 44%;

T. tonsurans 84% (21/25);

Terbinafine tablet, 10-20 kg:

Dropouts: one patient withdrew

terbinafine group: 76%

M. canis 16% (4/25)

62-5 mg/day; 20^0 kg:

with viral hepatitis (group not

Adverse effects: minimal side-effects such as gastric upset

Terbinafine group:

125 mg/day; >40 kg:

mentioned)

and nausea reported In both groups in 4% of patients, but It

T. tonsurans 64% (16/25);

250 mg/day) once a day for

No mention of compliance

was not necessary to discontinue therapy

M. canis 36% (9/25)

4 weeks plus 4 weeks of

assessment

placebo n = 25

No mention of Industry support

No co-treatment

Fuller et al. 200125 UK

Open, randomised, parallel

Griseofulvin suspension,

Follow up: 24 weeks

Mycological cure rates at week 24: griseofulvin group: 72%;

(London)

group

10 mg/kg/day, for 8 weeks

Method of randomisation:

terbinafine group: 70%

210 children 2-16 years old

n = 107

computer-generated; patients

Clinical cure rates'. No statistically significant difference In

Griseofulvin group

Terbinafine tablet, <20 kg:

randomised In blocks of four

clinical response between treatment groups at weeks 4, 8, 12

T. tonsurans 73%, other

62-5 mg/day; 20^0 kg:

Described as open

and 24

Trichophyton spp. 10%,

125 mg/day; >40kg: 250 mg/

ITT analysis

Complete cure rates at week 24: griseofulvin group: 67%;

Microsporum spp. 14%

day) for 4 weeks n = 103

Dropouts: 26 patients from

terbinafine group: 64%

Study

Trial design, sample size,

Interventions

Time of follow up, quality

Outcome measures

study population and

of reporting, dropouts

Adverse effects

types of fungus Isolated

and comments

Terbinafine group:

Co-treatment: selenium

terbinafine group; 37 from

Adverse effects: grlseofuvin group: 52 adverse events In 27

T. tonsurans 65%, other

sulphide shampoo, twice

griseofulvin group excluded

patients: abdominal discomfort and vomiting; 1 withdrawn

Trichophyton spp. 19.5%,

weekly for the first 2 weeks of

from ITT analysis

(abdominal pain, headaches and vomiting); terbinafine group

Microsporum spp. 14%

treatment

Compliance assessed by

57 adverse events In 36 patients: pruritus, urticaria and skin

direct questioning

scaling; 4 withdrawn (vomiting, dizziness, urticaria and weight

Supported by Novartls

loss)

(terbinafine)

Löpez-Gömez, etat.

Double-blind, randomised

Itraconazole 100 mg/day for

Follow up: 14 weeks

Mycological cure rates at week 14: Itraconzole group: 76-47%

199422 Spain (Madrid)

34 children <12 years; 1 adult

6 weeks n = 18

Described as randomised

(13/17);griseofulvin group: 78-57% (11/14)

Itraconazole group: M. canis

Griseofulvin (ultramicroslzed)

Described as double blind

Clinical cure at week 14: Total combined symptom severity

88-8% (16/18); T.

500 mg/day for 6 weeks

No ITT analysis

score decreased by 9% in the Itraconazole group and by 7%

mentagrophytes 5-5% (1/18);

n= 17

Dropouts: 1 In itraconazole

In the griseofulvin group

T. tonsurans 5-5% (1/18)

No co-treatment

group; 2 patients In

Complete cure rates at week 14: Itraconazole group: 88-23%

Griseofulvin group: M. canis

griseofulvin group because of

(15/17); griseofulvin group: 88-23% (15/17)

94-1% (16/17); T. vioiaceum

adverse events

Adverse effects: griseofulvin group: nausea; Intense stomach

5-9% (1/17)

No mention of compliance

ache with severe vomiting; Itraconazole group: none reported

assessment

Supported by Janssen

(Itraconazole)

Jahangir et ai. 199852

Double-blind, randomised

Itraconazole, <20 kg:

Follow up: 12 weeks

Mycological cure rates at week 12: Itraconazole group:

Pakistan (Lahore)

60 children any age; >10 kg

50 mg; 20^0 kg: 100 mg;

Described as randomised

85-7%; terbinafine group: 77-8%

Itraconazole group:

>40 kg: 200 mg - supposed

Described as double blind

Clinical cure at week 12: mean sum score of clinical signs

T. vioiaceum 82-1% (23/28);

daily - for 2 weeks n = 30

No ITT analysis

reduced by 83-7% In the itroconazole group and by 84-9% in

T. tonsurans 7-1% (2/28);

Terbinafine, <20 kg: 62-5 mg;

Dropouts: 2 In itraconazole

the terbinafine group

T. mentagrophytes 7-1% (2/28);

20-40 kg: 125 mg; >40 kg:

group; 3 in terbinafine group

Complete cure rates at week 12: Itraconazole group: 85-7%;

T. verrucosum 3-6% (1/28)

200-250 mg - supposed

because of Irregular follow up

all failures (n = 4) had T. vioiaceum tinea capitis; terbinafine

Study

Trial design, sample size,

Interventions

Time of follow up, quality

Outcome measures

study population and

of reporting, dropouts

Adverse effects

types of fungus Isolated

and comments

Terbinafine group:

dally - for 2 weeks n = 30

unrelated to therapy

group: 77-8% all failures (n = 6) has T violaceum tinea capitis

T. violaceum 88-8% (24/27);

No co-treatment

No mention of compliance

Adverse effects: itraconazole group: 2 urticaria; terbinafine

T. tonsurans 3 7% (1/27);

assessment

group: 2 fever, body aches and vertigo

T. mentagrophytes 3-7% (1/27);

No mention of industry support

T. verrucosum 3-7% (1/27)

Haroon et al. 1996"

Double-blind, randomised

Terbinafine, 10-20 kg:

Follow up: 12 weeks

Mycological cure rates at week 12: 1-week terbinafine:

Pakistan (Lahore,

161 patients; 156 (96-3%)

62-5 mg/day; 20^0 kg:

Described as randomised

49-1%; 2-week terbinafine: 19-6%; 4-week group 19-3%

Karachi)

were children <12 years old

125 mg/day; >40 kg:

Described as double blind

Clinical improvement at week 12: 1-week group: 83%; 2-week

T. violaceum 71-4% (115/161);

250 mg/day) once dally

No ITT analysis

group: 85%; 4-week group: 86%

T. tonsurans 14-9% (24/161);

for 1 week plus 3 weeks of

Dropouts: no mention of

Complete cure rates at week 12: 1-week group: 49-1%

T. verrucosum 4-3% (7/161);

placebo n = 53

withdrawals or dropouts

(26/53); 2-week group: 60-8% (31/51); 4-week group: 66-7%

M. audouinii4-3% (7/161);

for 2 weeks plus 2 weeks of

No mention of compliance

(38/57)

M. canis 2-5% (4/161);

placebo n = 51

assessment. Supported by

Adverse effects: 1-week group: 1 headache; 5 raised hepatic

T. schoenleinii 1-8% (3/161);

for 4 weeks n = 57

Sandoz (terbinafine)

enzymes; 3 raised triglycerides; 1 eosinophils, 1

T. mentagrophytes 0-6% (1/161)

No co-treatment

leucocytosis; 2-week group: 2 raised hepatic enzymes;

1 eoslnophilia; 4-week group: 2 raised hepatic enzymes;

2 raised triglycerides; 3 eoslnophilia and 1 leucocytosis

Kullavanijaya et al.

Single-blind, randomised

Terbinafine 62-5-250 mg

Follow up: 20 weeks.

Overall cure rates (complete cure and mycological cure) at

199754 Thailand

86 children >7 years old; 3

according to body weight -

Described as randomised.

week 12: 44-4% In the 1-week group; 57-1% in the 2-week

(Bangkok)

adults T. tonsurans,

supposed once dally -

Described as single blind but

group; 77-8% In the 4-week group; no further improvement In

M. ferruginosum, 7 patients (of

for 1 week n = 27

no mention of which one

the cure rates noted at week 20 (data not shown)

the three groups) had kerlon,

(completed the study)

(patients or observers)

Clinical cure: not reported

among these patients, 3 had

for 2 weeks n = 28

No ITT analysis

Adverse effects: none reported

M. ferrugineum Infection, 3 had

(completed the study)

Dropouts: 7 children were lost

mixed infection and 1 had

for 4 weeks n = 27

to follow up and excluded

T. tonsurans infection

(completed the study)

No mention of compliance

Table 34.1 (Continued)

Study

Trial design, sample size,

Interventions

Time of follow up, quality

Outcome measures

study population and

of reporting, dropouts

Adverse effects

types of fungus Isolated

and comments

No co-treatment

assessment. Supported by

Sandoz (terbinafine)

Talarico Filho et al.

Single-blind, randomised

Terbinafine 10-20 kg:

Follow up: 12 weeks.

Mycologlcal cure rates at week 12: 1-week group: 48-6%;

199833 Brazil (Sao

132 children 1-14 years old

62-5 mg/day; 20-40 kg:

Described as randomised.

2-week group: 60-5%; 4-week group: 69-7%

3aulo, Parana)

1-week group: M. canis 77-1%

125 mg/day; >40 kg:

Patients blinding (single blind).

Clinical cure rates at week 12: 1-week group: 54-3%; 2-week

(27/35); T. rubrum 8-6% (3/35);

250 mg/day once dally

No ITT analysis.

group: 60-5%; 4-week group: 84-8%

T. tonsurans 88-6% (3/35);

for 1 week plus 3 weeks of

Dropouts: only 107 patients

Complete cure rates at week 12: 1-week group: 45-7%;

T. mentagrophytes 2-8% (1/35);

placebo n = 42

completed the study (no

2-week group: 52-63%; 4-week group: 78-78%

T. schoenleinii 2-8% (1/35)

for 2 weeks plus 2 weeks of

mention In which group).

Adverse effects: 1-week group: 1 mild pruritus, 1 mild

2-week group: M. canis 73-3%

placebo n = 44

No mention of compliance

constipation; 2-week group: 1 mild headache, 2 moderate

(28/38); T. rubrum?-9% (3/38);

for 4 weeks n = 46

assessment. Supported by

nausea; 4-week group: 1 mild urticaria, 1 labial oedema, 1

T. tonsurans 18-5% (7/38)

No co-treatment

Sandoz (terbinafine)

mild constipation , 1 moderate loss of appetite, 1 mild

4-week group: M. canis 55-9%

diarrhoea, 1 mild nausea, 1 moderate partial loss of taste

19/34; T. rubrum 5-9% (2/34);

(recovery within 8 weeks)

T. tonsurans 26-5% (9/34);

T. mentagrophytes 5-9% (2/34);

T. schoenleinii2-9% (1/34);

M. gypseum 2-9% (1/34)

Hamm et al. 199935

Double-blind, randomised

Terbinafine 10-20 kg:

Follow up: 12 weeks.

Mycologycal cure rates: 86-9% (20/23) Trichophyton spp.

and abstracts36'37

35 children; mean age 9-3

62-5 mg/day; 20-40 kg:

No description of

Infections treated successfully with 1 or 2 weeks' terbinafine;

Germany (Warzburg,

years

125 mg/day; >40 kg:

randomisation process.

8-3% (1/12) patients with M. canis with short-course treatment

Marnberg)

1-week group: M. canis 43-7%

250 mg/day once daily

Described as double blind but

Clinical cure scores: symptoms score decreased from 12-9 to

(7/16); T. tonsurans 37-5%

for 1 week n = 16

no description of blinding

3-8 In Trichophyton infections and from 12-1 to 8-0 In

(6/16); T. violaceum 6-25%

for 2 weeks n = 19

between land 2 weeks groups

Microsporum infections In the 1-week group; from 11-3 to 0-6

(1/16); T. mentagrophytes

No co-treatment

No ITT analysis

in Trichophyton Infections and from 15-2 to 11-4 In

12-5% (2/16)

Microsporum infections In the 2-week group

Table 34.1 (Continued)

Study Trial design, sample size, study population and types of fungus Isolated

Interventions

Time of follow up, quality of reporting, dropouts and comments

Outcome measures Adverse effects

2-week group: M. canis 26-3%

Dropouts: no mention of

Complete cure rates: 1-week group: Trichophyton spp. 44-4%

(5/19)

T. tonsurans 31 -5%

withdrawals or dropouts.

(4/9); Microsporum spp. 0% (0/5); 2-week group:

(6/19)

T. vioiaceum 26-3%

No mention of compliance

Trichophyton spp. 64-28% (9/14); Microsporum spp. 0% (0/7);

(5/19)

T. mentagrophytes 5-3%

assessment. Supported by

additional 4 weeks treatment: Trichophyton spp. 33-3% (1/3);

(1/19)

T. soudanense 5-3%

Novartls (terblnaflne)

Microsporum spp. 33-3% (2/6)

(1/19)

T. verrucosum 5-3%

Adverse effects: 1-week group: 1 abdominal pain (mild to

(1/19)

moderate), 1 abdominal pain and epistaxis (mild to

moderate), 1 lack of appetite, headache and facial oedema

(severe), 1 coughing and fever (mild to moderate); 2-week

group: 1 abdominal pain, 1 abdominal pain and fatigue, 1

nausea, dyspepsia and headache, 1 fever; 4-week group: 1

lack of appetite and gastroenteritis

Solomon etat. 199 743 Open, randomised

Fluconazole tablets or

Follow up: 4 months

Mycological cure rates at month 4: 25% In the 1 -5 mg/kg/day

USA (New York) 41 children 2-15 years old

suspension:

Described as randomised

group; 60% In the 3 mg/kg/day group; 89% In the

Non-Inflammatory, T. tonsurans

1 -5 mg/kg/day for 20 days

Described as open-label

6 mg/kg/day group

100%

n = 8 (completed the study)

study

Clinical cure: Clinical Improvement noted on average by the

3 mg/kg/day for 20 days

No Intentlon-to-treat analysis

17th day in the 1-5 mg/kg/day group, the 16th day In the

n = 10 (completed the study)

Dropouts: 14 patients were lost

3 mg/kg/day group and the 12th day in the 6 mg/kg/day

6 mg/kg/day for 20 days

to follow up

group

n = 9 (completed the study)

No mention of compliance

Complete cure rates: not reported

No co-treatment

assessment. No mention as

Adverse effects: none reported

supported by Industry

ITT = ¡ntentlon-to-tract

ITT = ¡ntentlon-to-tract

RCT38 of 107 children with mainly M. canis tinea capitis compared 1, 2 and 4 weeks of terbinafine, 125-250 mg/day according to weight. At week 12, the mycological cure rate was 49% with only 1 week of therapy, 61% with 2 weeks and 70% with 4 weeks.

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