Evidence Table B3: DISCRETE outcomes for class KERATOLYTIC (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

B.01.01 Azelaic acid Placebo

Local side effects Present 2

Absent 18

Present 1

Absent 19

77

Parallel 

N=40

È

B.01.01 Azelaic acid Vehicle

Burning Present 4

Absent 39

Present 1

Absent 48

187

Parallel Mod

N=92

È Mid (12)

Erythema Present 2

Absent 41

Present 1

Absent 48

Mid (12)

Itching Present 2

Absent 41

Present 0

Absent 49

Mid (12)

Overall change/physician Excellent or good 28 0.05

Other 15

Excellent or good 18

Other 31

Mid (12)

Scaling Present 1

Absent 42

Present 2

Absent 47

Mid (12)

B.03.01 Salicylic acid Placebo

Acne change Greater than match 10

Equal 8

Worse than match 0

Greater than match 0

Equal 8

Worse than match 10

294

Parallel 

Mild/mod

N=30

Í Short (5)

Oiliness change Greater than match 11

Equal 7

Worse than match 0

Greater than match 0

Equal 7

Worse than match 11

Short (5)

Local reactions Skin burning 10

Eyes burning 1

Skin burning 0

Eyes burning 0

Mid (9.5)

Oiliness change Greater with match 5

Equal 6

Worse than match 6

Greater with match 0

Equal 6

Mid (9.5)

Acne change Greater than match 7

Equal 4

Worse than match 0

Greater than match 0

Equal 4

Worse than match 7

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 B DISCRETE: Page 1 of 3

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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

B.05.02 Sulfurated lime Vehicle

Severity change Excellent 9 0.015

Moderate 10

Slight 1

No change 6

Excellent 2

Moderate 5

Slight 2

No change 4

Worse 9

Dropouts 7

101

Parallel Mod

N=59

Mid (10)

Worse 4

Dropouts 0

Komed® (sulfur + salicylic acid 

+ resorcinol)

B.06.01 Placebo

Overall change/physician Komed® - proprietary 6

Komed® better than proprietary 7

Komed® worse than proprietary 4

Komed® - placebo 13

Komed® - proprietary 0

Komed® better than proprietary 0

Komed® worse than proprietary 0

Komed® -placebo 13

Komed® better than proprietary 21

Komed® worse proprietary 0

191

Parallel split 

face 

Mild/mod/sev

N=51

È

Komed® better than proprietary 21

Komed® worse proprietary 0

Komed® (sulfur + salicylic acid 

+ resorcinol)

Proprietary formula (sulfur + 

salicylic acid + re

B.06.02

Overall change/physician Komed® - proprietary 6

Komed® better than proprietary 7

Komed® worse than proprietary 4

Komed® - placebo 13

Komed® - proprietary 6

Komed® better than proprietary 7

Komed® worse than proprietary 4

Komed® -placebo 0

Komed® better than proprietary 0

Komed® worse proprietary 0

191

Parallel split 

face 

Mild/mod/sev

N=51

È

Komed® better than proprietary 21

Komed® worse proprietary 0

B.07.01 Aluminum chloride Vehicle

Overall change Improved 10 NS

No difference 3

Worse 10

Improved 3

No difference 4

Worse 16

165

Parallel split 

face Mild/mod

N=25

È Mid (8)

Aluminum chlorhydroxide + 

sulfur

B.07.02 Vehicle

Overall change/physician Improved 142 0.001

Not improved 59

Improved 76

Not improved 75

228

Parallel 

N=776

Short (5)

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 B DISCRETE: Page 2 of 3

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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

B.07.04 Gluconolactone Vehicle

Local effects Dryness, scaling, burning, stinging, 

redness 11

None 34

Dryness, scaling, burning, stinging, 

redness 5

None 41

176

Parallel 

Mod/sev

N=150

Í

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 B DISCRETE: Page 3 of 3

ÈÍ