Evidence Table B2. CONTINUOUS outcomes for class KERATOLYTIC (TOPICAL).

Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

Data Type: Mean (SD) Within P Data Type: Mean (SD) Within P

Target Between

 P-value

Comparison

B.01.01 Azelaic acid Placebo

77 Inflammatory change (%) Mid (12) Percent change: -50 Percent change: -10

Parallel 

È N=40 0.001

Non-inflammatory change (%) Mid (12) Percent change: -50 Percent change: -25 0.027

B.01.01 Azelaic acid Vehicle

187 Comedones change (%) Mid (12) Percent change: -56 Percent change: 0

Parallel Mod

È N=92 0.05

Inflammatory (count/median) Mid (12) Measure: 7 Measure: 16 0.05

B.01.02 Azelaic acid Benzoyl peroxide

52 Inflammatory (count/median) Short (4) Measure: 11 sig Measure: 9

Parallel Mild

N=309 sig

Overall change/physician (%) Short (4) Percent change: 28 Percent change: 32

Inflammatory (count)

Baseline counts: 19 (Target) / 18 

Percent Change*: -63 Percent Change*: -78

Overall change/physician (%) Percent change: 47 Percent change: 50

Good/excellent response (%) Percent change: 70 Percent change: 74

Inflammatory (count/median)

Acne change (% face)

Parallel Mild/mod

Í N=30

Face oiliness change (% face)

Acne change (% face)

Face oiliness change (% face)

Inflammatory (count)

Baseline counts: 32 (Target) / 32 

Percent Change*: -09 Percent Change*: -03

Parallel Mild/mod

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

and COMPARATOR: "Percent change"- an outcome derived from individual final and baseline measures; "Percent change*"- we calculated a group-based percentage change; "Change" - raw difference from baseline; 

"Change*" - calculated change; "Measure" - an outcome measure with no baseline comparison. SD: standard deviation. WITHIN P: P-value with respect to baseline in one arm. BETWEEN P-VALUE: comparison 

between Target and Comparator arms.

EvidenceTable B CONTINUOUS: Page 1 of 4

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

Data Type: Mean (SD) Within P Data Type: Mean (SD) Within P

Target Between

 P-value

Comparison

95 Non-inflammatory (count)

Baseline counts: 50 (Target) / 50 

Percent Change*: -28 Percent Change*: -18

Parallel Mild/mod

Overall change/patient (scale)

Total lesions (count)

Baseline counts: 83 (Target) / 83 

Percent Change*: -18 Percent Change*: -10

Inflammatory (count)

Baseline counts: 32 (Target) / 32 

Percent Change*: -28 Percent Change*: -09

Non-inflammatory (count)

Baseline counts: 50 (Target) / 50 

Percent Change*: -46 Percent Change*: -26

Overall change/patient (scale)

Total lesions (count)

Baseline counts: 83 (Target) / 83 

Percent Change*: -40 Percent Change*: -16

Count location: Face. 

Comedones (count)

Count location: Face. Baseline counts: 50 

(Target) / 50 (Comparator)

Short (4) Percent Change*: -30 NS Percent Change*: -26 NS

Erythema

Count location: Face. 

Short (4) Measure: 2 NS Measure: 3 NS NS

Papules (count)

Count location: Face. Baseline counts: 29 

(Target) / 41 (Comparator)

Short (4) Percent Change*: -31 .01 Percent Change*: -38 .01 NS

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

and COMPARATOR: "Percent change"- an outcome derived from individual final and baseline measures; "Percent change*"- we calculated a group-based percentage change; "Change" - raw difference from baseline; 

"Change*" - calculated change; "Measure" - an outcome measure with no baseline comparison. SD: standard deviation. WITHIN P: P-value with respect to baseline in one arm. BETWEEN P-VALUE: comparison 

between Target and Comparator arms.

EvidenceTable B CONTINUOUS: Page 2 of 4

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments Data Type: Mean (SD) Within P Data Type: Mean (SD) Within P

Target Between

 P-value

Comparison

101 Peeling

Count location: Face. 

Short (4) Measure: 1 NS Measure: 1

Parallel Mod

N=59 NS NS

Pustules (count)

Count location: Face. Baseline counts: 13 

(Target) / 13 (Comparator)

Short (4) Percent Change*: -62 .03 Percent Change*: -40 .03 NS

Comedones (count)

Count location: Face. Baseline counts: 50 

(Target) / 50 (Comparator)

Mid (10) Percent Change*: -30 .01 Percent Change*: -24 NS

Erythema

Count location: Face. 

Mid (10) Measure: 2 NS Measure: 3 NS NS

Papules (count)

Count location: Face. Baseline counts: 29 

(Target) / 41 (Comparator)

Mid (10) Percent Change*: 75 .01 Percent Change*: -44 .01 0.05

Peeling

Count location: Face. 

Mid (10) Measure: 1 NS Measure: 1 NS NS

Pustules (count)

Count location: Face. Baseline counts: 13 

(Target) / 13 (Comparator)

Mid (10) Percent Change*: -57 .03 Percent Change*: -40 .03 NS

B.07.04 Gluconolactone Vehicle

176 Inflammatory change (%)

Count location: Face. 

Short (4) Percent change: -49 Percent change: -39

Parallel Mod/sev

Í N=150 NS

Non-inflammatory change (%) Short (4) Percent change: -8 Percent change: -4 NS

Total lesions change (%) Short (4) Percent change: -15 Percent change: -7

Inflammatory change (%) Mid (12) Percent change: -59 .001 Percent change: -10 NS 0.05

Non-inflammatory change (%) Mid (12) Percent change: -17 NS Percent change: -4 NS

Total lesions change (%) Mid (12) Percent change: -22 .05 Percent change: -5 NS NS

Glycolic acid + soybean liposome

Closed comedones (count)

Parallel split face 

È N=40

Open comedones (count)

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

and COMPARATOR: "Percent change"- an outcome derived from individual final and baseline measures; "Percent change*"- we calculated a group-based percentage change; "Change" - raw difference from baseline; 

"Change*" - calculated change; "Measure" - an outcome measure with no baseline comparison. SD: standard deviation. WITHIN P: P-value with respect to baseline in one arm. BETWEEN P-VALUE: comparison 

between Target and Comparator arms.

EvidenceTable B CONTINUOUS: Page 3 of 4

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

Within P Within P

Target Between

 P-value

Comparison

246 Papules (count) Short (4) Raw count: 20 .005 Raw count: 29

Parallel split face 

Mild/mod

È N=40 .005 0.01

Closed comedones change (%) Mid (12) Percent change: -53 Percent change: -39 0.01

Open comedones change (%) Mid (12) Percent change: -65 Percent change: -50 0.01

Papules change (%) Mid (12) Percent change: -67 Percent change: -51

Pustules change (%) Mid (12) Percent change: -86 Percent change: -57 0.01

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

and COMPARATOR: "Percent change"- an outcome derived from individual final and baseline measures; "Percent change*"- we calculated a group-based percentage change; "Change" - raw difference from baseline; 

"Change*" - calculated change; "Measure" - an outcome measure with no baseline comparison. SD: standard deviation. WITHIN P: P-value with respect to baseline in one arm. BETWEEN P-VALUE: comparison 

between Target and Comparator arms.

EvidenceTable B CONTINUOUS: Page 4 of 4

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