Efficacy

The AHRQ systematic review14 examined seven placebo-controlled RCTs in patients with mild-to-severe acne42 53-58 (see Web Table 13.2). Changes in both NIL and IL were consistently significantly superior in the active group. Two RCTs reported mean reductions in lesion counts with 5% benzoyl peroxide: 52% and 60% for IL and 30% and 52% for NIL.42 55 The reductions in the vehicle comparator arms were less than 10% in each case. Four RCTs compared different dosages of benzoyl peroxide48,53,59 and no evidence was located to support a dose-response effect (Table 13.2).

Three RCTs compared topical tretinoin with 5% benzoyl peroxide.49,50,60 Tretinoin was shown to be more effective against NIL up to 12 weeks, but benzoyl peroxide had a greater impact on IL.

Author Comparators Number Severity Duration Blinding Outcomes Comments

Mills etal. 1986(2)55

1. 2.

BP 2-5% BP 5%

53

1/2

8

P, A

Equivalent efficacy and burning, peeling and erythemal

IL: 56% 1/58% reduction

2 LTF; not clear If randomised

Mills etal. 1986(3)55

1. 2.

BP 10% BP 2-5%

50

1/2

8

P, A

Equivalent efficacy but 10% more burning, erythema and peeling IL: 45% 1/47% reduction

No LTF; not clear If randomised

Yong 1979-

1. 2.

BP 2-5% BP 5 %

200

1/2/3

4-18

0

>50% reduction In lesion counts 64/96 1/74/98 (no SSD); erythema 45 1/50; desquamation 22 1/28; Itching/burning 16 v 10; no SSD overall

6 LTF, arms not comparable; Asian population; twice-daily application; Variable duration of treatment

Tretinoin 0-05%/ BP 10%

250

1/2/3

10

0

Overall change greater In 5% combination group; rate of local Intolerance 20% both groups but greater In 10% group; >50% reduction In NIL: 34/47 1/37/45 1/ 33/47 1/ 45/50 1/ 44/50 >50% reduction In IL: 27/36 v 34/42 1/28/41 1/34/44 1/39/49; no SSD between BP concentrations

11 LTF; not ITT; 47 patients needed alterations due to adverse reactions

BP 5%/0-5 g OT BP 5%/1 g OT BP 5%/1 -5 g OT

82

1/2/3

16

A

Patient adequate response: 2/23 1/6/24 1/8/19 1/12/17;

10 BP patients local Intolerance; IL: 56 1/70 1/75% 1/78% reduction

Assume randomised but not stated; previous failure to treatment; 10 LTF; not ITT

Fryand and Jakobsen 1986202

1. 2.

BP 5% (alcohol) BP 5% (water)

48

-

8

P, A

No difference In clinical effect but less Irritation In water-based preparation

Abstract only

Number, number of patients enrolled; severity (1 = mild; 2 = moderate; 3 = severe); duration (weeks); blinding (0 = open; A = assessor; P = patient); LTF, lost to follow up; ITT, Intentlon-to-treat; (N)IL, (non)-lnflamed lesions; SSD, statistically significant difference

Number, number of patients enrolled; severity (1 = mild; 2 = moderate; 3 = severe); duration (weeks); blinding (0 = open; A = assessor; P = patient); LTF, lost to follow up; ITT, Intentlon-to-treat; (N)IL, (non)-lnflamed lesions; SSD, statistically significant difference

Compared with topical 0-05% isotretinoin, 5% benzoyl peroxide had a greater effect on IL at 8 weeks but not 12 weeks and a similar effect on NIL at all time points in 77 patients with mild-to-moderate acne42; 5% benzoyl peroxide has similar efficacy to 20% azelaic acid in mild acne.61

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