Evidence Table C3: DISCRETE outcomes for class ANTI-BACTERIAL (TOPICAL).

Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

C.01.01 Clindamycin + vehicle Vehicle (oral) + vehicle (topical)

33 Diarrhea Present 1 Present 1

Parallel Mild

N=87

Mid (8)

Overall change/patient Marked improvement 19

Improved 3

No change 7

Worse 0

Marked improvement 0

Improved 1

No change 20

Worse 8

Mid (8)

Overall change/physcian Excellent 17

Good 6

Fair 1

Poor 5

Excellent 0

Good 0

Fair 4

Poor 25

Mid (8)

C.01.01 Clindamycin hydrochloride Vehicle

Diarrhea Diarrhea due to medication 0

Diarrhea 6

No diarrhea 117

Diarrhea due to medication 0

Diarrhea 2

No diarrhea 111

20

Parallel Mod

N=358

Mid (8)

Overall change/patient Worse 2 0.003

No change 26

Improved 68

Markedly improved 27

Worse 11

No change 38

Improved 52

Markedly improved 11

Mid (8)

327 Diarrhea Diarrhea 0 Diarrhea 0

Parallel 

Mild/mod

N=18

Erythema Erythema 3 Erythema 1

Itching Burning /itching 3 Burning/itching 2

Peeling Peeling 3 Peeling 2

Severity/patient Marked improvement 3

Some improvement 3

Slight improvement 

No change 3

Marked improvement 1

Some improvement 

Slight improvement 4

No change 

Mid (8)

C.01.01 Clindamycin phosphate Vehicle

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table C DISCRETE: Page 1 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Diarrhea Diarrhea due to medication 1

Diarrhea 5

No diarrhea 109

Diarrhea due to medication 0

Diarrhea 2

No diarrhea 111

20

Parallel Mod

N=358

Mid (8)

Overall change/patient Worse 3 0.003

No change 13

Improved 76

Markedly improved 22

Worse 11

No change 38

Improved 52

Markedly improved 11

Mid (8)

Overall change/physician Much improved 8

Improved 11

No change 1

Worse 1

Much improved 3

Improved 9

No change 2

Worse 0

199

Parallel 

Mild/mod

N=45

È Mid (12)

Severe side effects Burning 0

Itching 1

Burning 1

Itching 1

Mid (12)

C.01.02 Clindamycin Nicotinamide

305 Overall change/physician Much or moderately better 8 Much or moderately better 8 NS

Parallel Mod

N=76

Í Short (4)

Local side effects Mid (8) Local site reactions 9 Local site reactions 10

Overall change/physician Mid (8) Much or moderately better 19 Much or moderately better 18 NS

C.01.03 Clindamycin (gel) Clindamycin (solution)

Side effects Mild diarrhea 1

Upset stomach 0

Flare-up of acne 2

Skin dryness 3

Mild diarrhea 1

Upset stomach 1

Flare-up of acne 0

Skin dryness 9

267

Parallel Mild

N=60

Í

Overall change/investigator Improved or markedly improved 25

Other 5

Improved or markedly improved 27

Other 3

Mid (12)

Overall change/patient Improved 23

Other 7

Improved 28

Other 2

Mid (12)

C.01.03 Clindamycin (lotion) Clindamycin (solution)

Burning Present 6

Absent 26

Present 3

Absent 31

131

Parallel 

Mod/sev

N=70

È Short (6)

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table C DISCRETE: Page 2 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Dryness Present 13

Absent 19

Present 17

Absent 17

131

Parallel 

Mod/sev

N=70

È Short (6)

Erythema Present 11

Absent 21

Present 17

Absent 17

Short (6)

Itching Present 7

Absent 25

Present 3

Absent 31

Short (6)

Peeling Present 9

Absent 23

Present 5

Absent 29

Short (6)

Burning Present 2

Absent 30

Present 3

Absent 31

Mid (12)

Diarrhea Present 1

Absent 31

Present 2

Absent 32

Mid (12)

Dryness Present 13

Absent 19

Present 19

Absent 15

Mid (12)

Erythema Present 13

Absent 19

Present 15

Absent 19

Mid (12)

Itching Present 9

Absent 23

Present 4

Absent 30

Mid (12)

Overall change/patient Marked improvement 4

Improved 18

No change 9

Worse 1

Marked improvement 5

Improved 18

No change 7

Worse 4

Mid (12)

Overall change/physician Marked improvement 5

Improved 20

No change 6

Worse 1

Marked improvement 5

Improvement 19

No change 9

Worse 1

Mid (12)

Peeling Present 6

Absent 26

Present 5

Absent 29

Mid (12)

C.01.03 Clindamycin hydrochloride Clindamycin phosphate

Diarrhea Diarrhea due to medication 0

Diarrhea 6

No diarrhea 117

Diarrhea due to medication 1

Diarrhea 5

No diarrhea 109

20

Parallel Mod

N=358

Mid (8)

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table C DISCRETE: Page 3 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Overall change/patient Worse 2 0.003

No change 26

Improved 68

Markedly improved 27

Worse 3

No change 13

Improved 76

Markedly improved 22

20

Parallel Mod

N=358

Mid (8)

C.01.04 Clindamycin Erythromycin

Inter-treatment preference/patient Excellent 63 NS

Other 25

Excellent 75

Other 5

303

Parallel Mod

N=178

Mid (12)

Side effects Dropped out 0

Reduced dose 5

Other 12

None 69

Dropped out 1

Reduced dose 10

Other 12

None 58

Mid (12)

Overall change/patient Excellent + good 24 NS

Other 12

Excellent + good 25

Other 11

326

Parallel 

Mod/sev

N=72

Mid (12)

Overall change/patient Excellent + good 24 NS

Other 12

Excellent + good 25

Other 11

Mid (12)

C.01.04 Clindamycin phosphate Erythromycin

Adverse reactions Erythema/blistering 1

Diarrhea/vomiting 1

Acne exacerbation 1

Erythema/blistering 0

Diarrhea/vomiting 0

Acne exacerbation 0

158

Parallel Mod

N=120

È Mid (8)

C.01.05 Clindamycin Tetracycline

Severity assessment Poor 1 0.02

Fair 13

Good 25

Excellent 5

Poor 11

Fair 10

Good 18

Excellent 4

291

Parallel Mild

N=92

È Mid (8)

Side effects

Between P-value: burning .05

Itch 0 NS

Irritation 0

Diarrhea 1

Vaginitis 1

Itch 1

Irritation 1

Diarrhea 1

Vaginitis 0

Hematuria 0

Mid (8)

Hematuria 1

C.01.05 Clindamycin Tetracycline hydrochloride

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table C DISCRETE: Page 4 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Erythema None 15 NS

Mild 6

Moderate 1

None 19

Mild 8

Moderate 0

261

Parallel 

Mild/mod

N=52

Í Mid (8)

Itching/burn None 22 NS

Mild 1

Moderate 0

None 23

Mild 4

Moderate 0

Mid (8)

Overall improvement (discretized %) Good (67-100%) 10 0.01

Fair (34-66%) 10

Poor (<33%) 2

Good (67-100%) 7

Fair (34-66%) 7

Poor(<33%) 13

Mid (8)

Peeling None 22 NS

Mild 1

None 25

Mild 2

Mid (8)

Side effects Diarrhea 2

Film of yellow discoloration 0

Diarrhea 0

Film of yellow discoloration 26

Mid (8)

C.03.01 Erythromycin Vehicle

Burning-irritation Mild 3

Moderate 0

Severe 0

Mild 5

Moderate 6

Severe 1

184

Parallel Mod

N=175

È Mid (12)

Dryness Mild 3

Moderate 1

Severe 0

Mild 3

Moderate 1

Severe 1

Mid (12)

Exudate Mid (12) Moderate 1 Moderate 0

Eye irritation Mid (12) Present 2 Present 0

Herpes simplex Mid (12) Mild 1 Mild 0

Oiliness Mid (12) Mild 1 Mild 1

Overall change/physician Excellent 31 0.001

Good 21

Partially improved 17

Not improved 10

Excellent 8

Good 12

Partially improved 25

Not improved 23

Worse 7

Mid (12)

Worse 2

Pruritis Mild 2

Not stated 1

Mild 9

Not stated 

Mid (12)

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table C DISCRETE: Page 5 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Redness Mild 4

Moderate 0

Severe 1

Mild 6

Moderate 3

Severe 0

184

Parallel Mod

N=175

È Mid (12)

Scaling Mild 4

Moderate 2

Severe 0

Mild 3

Moderate 4

Severe 1

Mid (12)

Side effects Any (continued) 15

Any (withdraw) 2

Any (continued) 17

Any (withdraw) 4

Mid (12)

Erythema None 84

Mild 18

Moderate 2

Moderate severe 1

None 82

Mild 18

Moderate 2

Moderate severe 1

Severe 0

205

Parallel 

Mild/mod

N=225

Mid (12)

Severe 0

Peeling None 95

Mild 8

Moderate 2

Moderate severe 0

None 96

Mild 5

Moderate 2

Moderate severe 0

Severe 0

Mid (12)

Severe 0

Lesions change Any change less than 0 51 NS

50% or less change 21

Any change less than 0 40

50% or less change 14

277

Parallel split 

face Mild/mod

N=73

Mid (8)

C.04.01 Fusiden Vehicle

Side effects Mild itching 1

Diffuse exanthema 0

None 35

Mild itching 0

Diffuse exanthema 1

None 33

151

Parallel 

Mild/mod

N=79

Short (3)

C.05.01 Meclocycline Benzoyl peroxide

Skin discoloration Present 2

Absent 31

Present 1

Absent 35

30

Parallel Mod

N=102

È Mid (10)

C.06.01 Metronidazole Placebo

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table C DISCRETE: Page 6 of 7

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Local irritation Present 2

Absent 46

Present 1

Absent 47

328

Parallel 

Mild/mod

N=96

È

Side effects Redness 0

Dryness 0

Redness 0

Dryness 0

Mid (8)

Tetracycline (topical) + placebo 

(oral)

C.08.01 Vehicle (topical) + placebo (oral)

Severity change > 1 unit decrease 14 NS

< 1 unit decrease 3

No change 2

> 1 unit decrease 6

< 1 unit decrease 4

No change 7

10

Parallel Mod

N=60

Mid (8)

Tetracycline (topical) + placebo 

(oral)

C.08.03 Benzoyl peroxide + placebo (oral)

Side effects Severe facial reaction 0

GI symptoms 2

Vaginal candidiasis 0

Severe facial reaction 1

GI symptoms 2

Vaginal candidiasis 1

255

Parallel Mod

N=69

Mid (12)

C.09.02 Triclosan Phisohex

Overall change/patient

Between P-value: Where pt & doctor 

agreed, pref was for triclosan, p. 05

Worse 6 NS

No change 2

Some improvement 11

Marked improvement 12

Worse 3

No change 11

Some change 11

Marked improvement 6

Not answered 2

21

Cross-over 

Mild/mod/sev

N=34

Short (6)

Not answered 2

Overall change/physician

Between P-value: Where pt & doctor 

agreed, pref was for triclosan, p. 05

No change 7 NS

Some improvement 16

Marked improvement 6

Not answered 4

No change 10

Some improvement 15

Marked improvement 6

Not answered 2

Short (6)

Side effects Local drying/scaling/itching 11

Erythema/soreness (withdraw) 2

Local drying/scaling/itching 9

Erythema/soreness (withdraw) 3

Short (6)

TRIAL: -presence of positive or negative methodological features (see Summary Table). "Mild/mod," etc., -our assessment of entry severity of study patients. "P"- to parallel study, "S"-split face design. BETWEEN 

P-VALUE: comparison between Target and Comparator arms.

Evidence Table C DISCRETE: Page 7 of 7

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