Efficacy

Surprisingly, of the 24 papers that have dealt with this drug, 19 report RCTs (one was an intention-to-treat trial). Of the remaining five, two are definitely CCTs, two were anecdotal reports and I do not have information on the last one. The papers are quite homogeneous. Five of them compared metronidazole with oral tetracycline. One found that azelaic acid was superior and another that permethrin has the same efficacy. Other formulations such as 0-75% lotion, cream and gel have been found to be equivalent. In general, the improvement ranged from 52% to 89% (Table 14.1). In another RCT (not included in Table 14.1), 88 patients successfully treated with oral tetracycline and topical metronidazole, were treated with either 0-76% metronidazole gel or vehicle. Relapses after 6 months of treatment were significantly fewer (23%) with metronidazole than with the vehicle (42%).45

Table 14.1 Trials with topical metronidazole

Reference

Design

Number

Dosage and

Results

Comments

of patients

vehicle, duration

(% improvement)

24

RCT

41

1% cream, 8 wks

64% papules improved

Dryness

v 39% P

25

?

51

1% cream, 8 wks

Improvement vT

26

CCT

33

1% cream/day,

Fewer relapses v oral T

16 wks + 1% every

other day

27

RCT

44?

1% cream ?

Non-significant

improvement v P

28

RCT

34

1% cream, 8 wks

89% lesions v 100% T

Dryness and

stinging

29

RCT

40

0-75% gel, 9 wks

65% lesions v 15% P

No side-effects

30

RCT

59

0-75% gel, 9 wks

Significant improvement vP

No side-effects

31

RCT

50

1% cream, 8 wks

88% v P

32

RCT

97

1% cream, 8 wks

Significant improvement vP

No side-effects

33

RCT

42

1% cream, 8 wks

60% v 23% P

34

RCT

12

0-5% gel, 9 wks

75% v 75% T

4

CCT

50

1% cream, 8 wks

53% v 61% T

No side-effects

35

RCT

40

0-75% gel, 3 mo

35% v 49% E

No statistical

analysis

36

RCT

26

0-75% gel, 6 wks

48% v 17% P

Mediocre

tolerability

37

RCT

6

0-75% gel, 7-10

64% v 64% PE

Dryness in one

wks

patient

38

RCT

85

0.75% gel, 12 wks

52-1% v22-4% P

39

RCT

143a

1% cream, 10 wks

62-5% 1/42-9% P

40

RCT

89

1% cream, 10 wks

53% v 17% P

2% had adverse

effects

41

RCT

69

1% cream, 10 wks

58% v 30% P

Skin reactions in

three patients

42

RCT

100

0-75% gel and

61% v 63%

No difference

cream, 12 wks

43

(ITT)

57

0.75% lotion and

71% v63%

No difference

gel, 12 wks

44

RCT

40

0-75% gel, 15 wks

69-4% v78-5% A

Dryness,

burning, stinging

RCT, randomised clinical trial; CCT, controlled non-randomised clinical trial; IIT, intention-to-treat trial; P, placebo; T, tetracycline; E, erythromycin; A, azithromycin; PE, permethrin. aNumbers of individual groups are not reported.

Table 14.2 Trials with topical azelaic acid

Reference

Type of study

Number of patients

(% improvement)

Comments

46

OS

33

20% cream

Reduction of lesions

47

?

?

20% cream

78% v31% P

48

RCT

114

20% cream,

73% v51% P

17% stopped

12 wks

(5 for irritation)

44

RCT

40

20% cream,

78% v 69%

Stinging

15 wks

metronidazole

RCT, randomised controlled trial; OS, open study P, placebo

RCT, randomised controlled trial; OS, open study P, placebo

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