Evidence Table D2. CONTINUOUS outcomes for class ANTI-BACTERIAL (TOPICAL)/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

D.01.01 Benzoyl peroxide Vehicle

173 Inflammatory (count)

Count location: Face. Baseline counts: 44 

(Target) / 44 (Comparator)

Short (4) Percent Change*: -43 Percent Change*: -05

Parallel Mild/mod

È N=77 NS

176 Inflammatory change (%)

Count location: Face. 

Short (4) Percent change: -42 Percent change: -39

Parallel Mod/sev

Í N=150 NS

173 Non-inflammatory (count)

Count location: Face. Baseline counts: 48 

(Target) / 49 (Comparator)

Short (4) Percent Change*: -23 .05 Percent Change*: 02

Parallel Mild/mod

È N=77

176 Non-inflammatory change (%)

Count location: Face. 

Short (4) Percent change: -24 Percent change: -4

Parallel Mod/sev

Í N=150 NS

173 Severity (leeds) Short (4) Measure: 1 .01 Measure: 1

Parallel Mild/mod

È N=77 NS 0.01

176 Total lesions change (%) Short (4) Percent change: -25 Percent change: -7

Parallel Mod/sev

Í N=150

241 Total lesions change (%) Short (6) Percent change: -44 Percent change: -3

Parallel Mild/mod

È N=50 0.01

Total lesions change (%) Mid (8) Percent change: -51 Percent change: -18 0.01

173 Inflammatory (count)

Count location: Face. Baseline counts: 44 

(Target) / 44 (Comparator)

N=77 Mid (12) Percent Change*: -52 .01 Percent Change*: 09 NS 0.01

176 Inflammatory change (%)

Count location: Face. 

Mid (12) Percent change: -60 .05 Percent change: -10

Parallel Mod/sev

Í N=150 NS 0.05

173 Non-inflammatory (count)

Count location: Face. Baseline counts: 48 

(Target) / 49 (Comparator)

Mid (12) Percent Change*: -52 .01 Percent Change*: 06

Parallel Mild/mod

È N=77 NS 0.01

176 Non-inflammatory change (%)

Count location: Face. 

Mid (12) Percent change: -30 .02 Percent change: -4

Parallel Mod/sev

Í N=150 NS 0.05

173 Severity (leeds) Mid (12) Measure: 0 .01 Measure: 1

Parallel Mild/mod

È N=77 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 D CONTINUOUS: Page 1 of 7

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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

176 Total lesions change (%)

Count location: Face. 

Mid (12) Percent change: -31 .02 Percent change: -5

Parallel Mod/sev

Í N=150 NS NS

D.01.01 Benzoyl Peroxide (20%) Vehicle

314 Total lesion (count)

Count location: Entire face. Baseline counts: 

19 (Target) / 16 (Comparator)

Short (6) Percent Change*: -58 Percent Change*: -25

Parallel Mod

N=59

Total lesion (count) Mid (12) Percent Change*: -53 Percent Change*: -25

D.01.03 Benzoyl peroxide Gluconolactone

176 Inflammatory change (%)

Count location: Face. 

Short (4) Percent change: -42 Percent change: -49

Parallel Mod/sev

Í N=150 NS

Non-inflammatory change (%) Short (4) Percent change: -24 Percent change: -8 NS

Total lesions change (%) Short (4) Percent change: -25 Percent change: -15

Inflammatory change (%) Mid (12) Percent change: -60 .05 Percent change: -59 .001 0.05

Non-inflammatory change (%) Mid (12) Percent change: -30 .02 Percent change: -17 NS 0.05

Total lesions change (%) Mid (12) Percent change: -31 .02 Percent change: -22 .05 NS

D.01.04 Benzoyl peroxide Salicylic acid

304 Comedones change [phase i] (%)

Count location: Undefined. 

Short (2) Percent change: -20 NS Percent change: -34

Cross-over Mild

È N=30 .01 NS

Comedones change [phase ii] (%) Short (2) Percent change: 10 NS Percent change: -9 .05 NS

D.01.05 Benzoyl peroxide Sulfur + resorcinol

272 Total lesions change (%)

Count location: Left side. 

Long (14 Percent change: -32 Percent change: -16

Parallel 

N=189

D.01.09 Benzoyl peroxide (2.5%) Benzoyl peroxide (10%)

243 Total lesions change (%) Short (6) Percent change: -45 Percent change: -39

Parallel Mild/mod

È N=50 NS

Total lesions change (%) Mid (8) Percent change: -47 Percent change: -45 NS

D.01.09 Benzoyl peroxide (2.5%) Benzoyl peroxide (5%)

242 Total lesions change (%) Short (6) Percent change: -54 Percent change: -47

Parallel Mild/mod

È N=52 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 D CONTINUOUS: Page 2 of 7

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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

242 Total lesions change (%) Mid (8) Percent change: -56 Percent change: -58

Parallel Mild/mod

È N=52 NS

D.01.09 Benzoyl peroxide (acetone) Benzoyl peroxide (alcohol)

221 Comedones change (%) Mid (8) Percent change: -62 Percent change: -57

Parallel Mod

Í N=147 NS

Papules change (%) Mid (8) Percent change: -56 Percent change: -56 0.02

Pustules change (%) Mid (8) Percent change: -80 Percent change: -79 NS

D.01.09 Benzoyl peroxide (lotion) Benzoyl peroxide (gel)

76 Inflammatory (count)

Count location: Face (unspecified). Baseline 

counts: 32 (Target) / 28 (Comparator)

Short (4) Percent Change*: -22 .02 Percent Change*: -32

Parallel Mod

N=48 .01 NS*

Non-inflammatory (count)

Count location: Face (unspecified). Baseline 

counts: 57 (Target) / 58 (Comparator)

Short (4) Percent Change*: -32 .01 Percent Change*: -17 .01 NS*

Overall change/patient (% improvement)

Count location: Vas. 

Short (4) Measure: 19 (4.) Measure: 22 (8.) NS*

Severity (pillsbury)

Count location: Face (unspecified). 

Short (4) Measure: 2 (1.1) .05 Measure: 2 (1.1) .05 NS*

Inflammatory (count)

Count location: Face (unspecified). Baseline 

counts: 32 (Target) / 28 (Comparator)

Mid (8) Percent Change*: -28 .01 Percent Change*: -39 NS*

Non-inflammatory (count)

Count location: Face(unspecified). Baseline 

counts: 57 (Target) / 58 (Comparator)

Mid (8) Percent Change*: -39 .001 Percent Change*: -28 .001 NS*

Overall change/patient (% improvement)

Count location: Vas. 

Mid (8) Measure: 28 (10.) Measure: 32 (20.) NS*

Severity (pillsbury)

Count location: Face (unspecified). 

Mid (8) Measure: 2 (0.5) .01 Measure: 2 (0.5) .01 NS*

D.01.09 Benzoyl peroxide (water) Benzoyl peroxide (alcohol)

118 Closed comedones change (%) Short (4) Percent change: -77 Percent change: -76

Parallel split face 

N=49 NS

Cysts change (%) Short (4) Percent change: -100 Percent change: -100 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 D CONTINUOUS: Page 3 of 7

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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

118 Open comedones change (%) Short (4) Percent change: -95 Percent change: -100

Parallel split face 

N=49 NS

Papules change (%) Short (4) Percent change: -70 Percent change: -73 NS

Pustules change (%) Short (4) Percent change: -92 Percent change: -100 NS

Closed comedones change (%) Mid (8) Percent change: -88 Percent change: -90 NS

Cysts change (%) Mid (8) Percent change: -100 Percent change: -100 NS

Open comedones change (%) Mid (8) Percent change: -100 Percent change: -100 NS

Papules change (%) Mid (8) Percent change: -80 Percent change: -82 NS

Pustules change (%) Mid (8) Percent change: -100 Percent change: -100 NS

D.05.01 Benzoyl peroxide + erythromycin Placebo

310 Comedones (count)

Baseline counts: 7 (Target) / 6 (Comparator)

Short (4) Percent Change*: -50 .004 Percent Change*: -18

Parallel Mild/mod

È N=92 .001 NS

Inflammatory (count)

Baseline counts: 21 (Target) / 18 

(Comparator)

Short (4) Percent Change*: -43 .001 Percent Change*: -19 .003 0.008

Total lesions (count)

Baseline counts: 28 (Target) / 29 

(Comparator)

Short (4) Percent Change*: -44 .001 Percent Change*: -31 .001 NS

Comedones (count)

Baseline counts: 7 (Target) / 6 (Comparator)

Mid (12) Percent Change*: -46 .06 Percent Change*: 00 .001 NS

Inflammatory (count)

Baseline counts: 21 (Target) / 18 

(Comparator)

Mid (12) Percent Change*: -53 .001 Percent Change*: -26 .02 0.01

Total lesions (count)

Baseline counts: 28 (Target) / 29 

(Comparator)

Mid (12) Percent Change*: -51 .001 Percent Change*: -32 .001 NS

D.05.02 Erythromycin + benzoyl peroxide Clindamycin phosphate

260 Comedones (count)

Count location: Face. 

Short (4) Raw count: 17 (42.) Raw count: 26 (42.)

Parallel Mild/mod

È N=205 0.001

Inflammatory (count) Short (4) Raw count: 12 (7.) Raw count: 13 (7.) NS*

Comedones (count) Mid (10) Raw count: 14 (42.) Raw count: 24 (42.) 0.001

 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 D CONTINUOUS: Page 4 of 7

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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

260 Inflammatory (count)

Count location: Face. 

Mid (10) Raw count: 9 (29.) Raw count: 16 (29.)

Parallel Mild/mod

È N=205 0.001

Overall change (score) Mid (10) Measure: 2 (1.7) Measure: 2 (1.7) NS*

Overall change (score) Mid (10) Measure: 3 (3.8) Measure: 2 (3.8) NS*

D.05.04 Benzoyl peroxide + erythromycin Zinc + erythromycin

62 Clinical assessment/physician (score) Short (6) Measure: 4 (0.9) Measure: 3 (1.1)

Parallel Mod

Í N=72 0.001

Comedones change (median %) Short (6) Measure: -76 Measure: -48 NS

Inflammatory change (count/median) Short (6) Measure: -35 Measure: -18 0.005

Clinical assessment/physician (score) Mid (10) Measure: 4 (0.7) Measure: 3 (1.1) 0.001

Comedones change (median %) Mid (10) Measure: -87 Measure: -60 NS

Inflammatory change (count/median) Mid (10) Measure: -53 Measure: -27 0.005

D.06.01 Meclocycline + benzoyl peroxide Benzoyl peroxide

30 Comedones (count)

Count location: Face. Baseline counts: 9 

(Target) / 10 (Comparator)

Short (6) Percent Change*: -11 Percent Change*: -58

Parallel Mod

È N=102

Papules (count)

Count location: Face. Baseline counts: 21 

(Target) / 21 (Comparator)

Short (6) Percent Change*: -38 Percent Change*: -48

Pustules (count)

Count location: Face. Baseline counts: 7 

(Target) / 9 (Comparator)

Short (6) Percent Change*: -17 Percent Change*: -56

Comedones (count)

Count location: Face. Baseline counts: 9 

(Target) / 10 (Comparator)

Mid (10) Percent Change*: -44 Percent Change*: -68 0.05

Papules (count)

Count location: Face. Baseline counts: 21 

(Target) / 21 (Comparator)

Mid (10) Percent Change*: -43 Percent Change*: -62 NS

Pustules (count)

Count location: Face. Baseline counts: 7 

(Target) / 9 (Comparator)

Mid (10) Percent Change*: -23 Percent Change*: -58 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 D CONTINUOUS: Page 5 of 7

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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

D.08.01 Benzoyl peroxide + miconazole Benzoyl peroxide

111 Comedones (count)

Baseline counts: 61 (Target) / 53 

(Comparator)

Short (4) Percent Change*: -41 sig Percent Change*: -49

Parallel Mod/sev

Í N=52 sig NS

Irritation Short (4) Measure: 0 (0.5) Measure: 1 (0.43) 0.01

Irritation [Females] Short (4) Measure: 0 (0.42) Measure: 1 (0.28) 0.001

Irritation [Male] Short (4) Measure: 0 (0.57) Measure: 1 (0.5) NS

Papules (count)

Baseline counts: 10 (Target) / 8 (Comparator)

Short (4) Percent Change*: -51 sig Percent Change*: -63 sig NS

Pustules (count)

Baseline counts: 4 (Target) / 4 (Comparator)

Short (4) Percent Change*: -65 sig Percent Change*: -79 sig NS

Total lesions (count)

Baseline counts: 73 (Target) / 63 

(Comparator)

Short (4) Percent Change*: -44 sig Percent Change*: -52 sig NS

231 Comedones change (geometric mean)

Count location: Face. 

Mid (8) Measure: -62 (28.) Measure: -54 (63.)

Parallel Mild/mod/sev

È N=20 NS

Inflammatory change (geometric mean) Mid (8) Measure: -79 (15.) Measure: -98 (60.) NS

111 Comedones (count)

Baseline counts: 61 (Target) / 53 

(Comparator)

Mid (12) Percent Change*: -65 sig Percent Change*: -72

Parallel Mod/sev

Í N=52 sig NS

Irritation Mid (12) Measure: 0 (0.32) Measure: 0 (0.46) NS

Irritation [Female] Mid (12) Measure: 0 (0.28) Measure: 0 (0.49) NS

Irritation [Male] Mid (12) Measure: 0 (0.34) Measure: 0 (0.42) NS

Papules (count)

Baseline counts: 10 (Target) / 8 (Comparator)

Mid (12) Percent Change*: -69 sig Percent Change*: -69 sig NS

Pustules (count)

Baseline counts: 4 (Target) / 4 (Comparator)

Mid (12) Percent Change*: -81 sig Percent Change*: -84 sig NS

Total lesions (count)

Baseline counts: 73 (Target) / 63 

(Comparator)

Mid (12) Percent Change*: -66 sig Percent Change*: -73 sig NS

Total lesions change (%) Mid (12) Percent change: -63 

(27.1)

sig Percent change: -69 

(18.7)

sig 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 D CONTINUOUS: Page 6 of 7

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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

111 Total lesions change [female] (%)

Between P-value: vs men.

Mid (12) Percent change: -74 

(15.9)

Percent change: -73 

Parallel Mod/sev (13.9)

Í N=52 0.02

Total lesions change [male] (%)

Between P-value: vs women.

Mid (12) Percent change: -50 

(30.7)

Percent change: -66 

(21.7)

0.02

D.08.01 Miconazole + benzoyl peroxide Benzoyl peroxide

85 Comedones (count)

Count location: Entire face. Baseline counts: 

36 (Target) / 36 (Comparator)

Mid (8) Percent Change*: -75 Percent Change*: -61

Parallel Mod

È N=105 0.001

Comedones (count) Mid (12) Percent Change*: -92 Percent Change*: -69 0.001

 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 D CONTINUOUS: Page 7 of 7

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