Efficacy

The AHRQ review included four relevant RCTs15-17 and additional searches provided three others.18-20 Five of the studies were double blind (Table 13.1); only two studies enrolled more than 100 patients.

The largest RCT showed that an acidic soap-free syndet was less irritant than soap and reduced both inflamed lesions (IL) and non-inflamed lesions (NIL) in 120 patients with mild acne who were not taking any other anti-acne medication.16 There were no significant differences between the groups, although the individuals using soap experienced a mean increase in both NIL and IL over 12 weeks and 23/57 experienced irritation, compared with 1/57 in the soap-free group.

Cleansers containing the antibacterial hexachlorophene produced improvement in

Is there any evidence to support the routine use of skin cleansers and/or abrasives in the management of mild-to-moderate acne?

Author Comparators Number Severity Duration Blinding Results Comments

Bettley and Dale 197615

1. Hexachlorophene

2. Trlclosan

34

1/2/3

6/6

0

No significant differences; drug Improved: 21/28 1/22/28; local reaction: 11 1/9

6 LTF; not ITT; crossover study; no wash-out period

Fulghum etat. 198213

1. Sulphur/salicylic acid cleanser with polyethylene granules

2. Sulphur/salicylic acid cleanser

53

1/2

8

0

Both reduced IL and NIL; no significant differences; equal sensitivity

7 LTF; not ITT; split half-face study; no concomitant therapy

Kanof 1971 (Part 2)13

1. Antibacterial soap

2. Soap

51

3

>12

A, P

Flare 13/30 1/22/31

Tetracycline responders; no details on concomitant therapy

Kanof 1971 (Part 1)13

1. Antibacterial soap

2. Soap

86

3

4

A, P

Response 30/44 1/31/42

All tetracycline 250 mg 2 or 3 times dally; no details on concomitant therapy; not ITT

Körting etat. 19951£l

1. Acidic syndet bar

2. Soap

120

1

12

0

1 reduced IL and NIL; 2 Increased IL and NIL; no Intergroup comparison

2-week wash-out; 6 LTF; ITT analysis; Soap 5 dropouts exacerbation; no concomitant therapy

Mlllkan 1976 (A)17

1. Povldone-lodlne cleanser

2. Vehicle

30

1

12-16

A, P

Improved 9/10 1/3/7; Intolerance 1 = 2

13 LTF; not ITT

Mlllkan 1976 (B)17

1. Povldone-lodlne cleanser

2. Vehicle

30

2

12-16

A, P

10/13 v 12/14 Improved; 0 Intolerance

3 LTF; all tetracycline 250 mg 1 or 2 times dally

(Continued)

(Continued)

Table 13.1 (Continued)

Author

Comparators

Number

Severity

Duration

Blinding Results

Comments

Stoughton 1987 (A)20

1. Chlorhexidine gluconate cleanser 4% Benzoyl peroxide 5%

50

2

12

A

No significant differences IL or NIL

3 LTF; not ITT; no concomitant therapy twice-daily application

Stoughton and Leyden 1987 (B)20

1. Chlorhexidine gluconate cleanser 1 -4%

2. Vehicle

110

2

12

A

1 > 2 IL and NIL; dry skin: 3 vl

17 LTF; not ITT; no concomitant therapy twice-daily application

2. No abrasion

50

2

12

A

No Intergroup comparisons: suggestion that abrasion better but no data

2 LTF; not ITT; all patients received 5% benzoyl peroxide; split-face study

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, Intention-to-treat; NIL, non-inflamed lesions; IL, infamed lesions equivalent numbers of patients to triclosan in a 12-week crossover trial with 34 patients,15 although no wash-out period was permitted. Eleven patients experienced local reactions to triclosan and nine to hexachlorophene; hexachlorophene is now not recommended. Chlorhexidine was shown to produce equivalent significant reductions in NIL and IL in 50 patients with moderate acne when compared with 5% benzoyl peroxide at 12 weeks. It also produced significantly greater reductions in IL and NIL than those treated with the vehicle alone in 110 individuals, again at 12 weeks.20

In individuals treated with tetracycline, 500 mg twice daily, additional use of antibacterial soap in a 4-week period offered no benefit over use of normal soap. However, it was shown to significantly reduce the incidence of acne flare in responders to 4-week tetracycline therapy in a 90-day follow up (13/30 flared v22/31).19

After 12-14 weeks' use in a double-blind RCT, povidone-iodine skin cleanser improved 9/10 patients with mild acne, compared with 3/7 in the vehicle group. The results are invalidated however by the high losses to follow up.17 The results in a second group of patients with more severe acne who also received tetracycline, 250 mg once or twice daily, were equivocal (10/13 compared with 12/14).17 Only one case of mild itching was experienced.

The addition of abrasives to a combination of sulphur and salicylic acid in a split-half-face study in 44 patients did not show any difference in either efficacy or tolerability after 8 weeks. The potential for the effects of the active ingredients to mask all other effects must be considered.18 One split-face study evaluated the use of additional abrasion to 5% benzoyl peroxide therapy but there were no intergroup comparisons to validate the authors' claim that the side of the face treated with abrasion showed better results.21

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