Evidence Table C2. CONTINUOUS outcomes for class ANTI-BACTERIAL (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

C.01.01 Clindamycin Vehicle

217 Closed comedones (count)

Baseline counts: 44 (Target) / 39 

(Comparator)

Mid (12) Percent Change*: -25 NS Percent Change*: -31

Parallel Mod

È N=42 NS NS

Open comedones (count)

Baseline counts: 30 (Target) / 13 

(Comparator)

Mid (12) Percent Change*: -34 .01 Percent Change*: 64 NS NS

Papules (count)

Baseline counts: 33 (Target) / 40 

(Comparator)

Mid (12) Percent Change*: -36 .01 Percent Change*: -38 .02 NS

Pustules (count)

Baseline counts: 9 (Target) / 8 (Comparator)

Mid (12) Percent Change*: -22 NS Percent Change*: -13 NS NS

Severity (leeds) Mid (12) Measure: 1 .01 Measure: 1 NS NS

Severity/flash photo (leeds) Mid (12) Measure: 2 .03 Measure: 1 .04 NS

Severity/fluorescent photo-face+nose (leeds) Mid (12) Measure: 1 NS Measure: 1 .001 0.02

Severity/fluorescent photo-nose (leeds) Mid (12) Measure: 1 .001 Measure: 2 NS NS

Severity/fluorescent photography Mid (12) Measure: 1 .002 Measure: 2 NS NS

C.01.01 Clindamycin phosphate (lotion) Placebo

99 Papules (count)

Baseline counts: 21 (Target) / 23 

(Comparator)

Short (6) Percent Change*: -29 Percent Change*: -20

Parallel Mod

Í N=135 0.05

Pustules (count)

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

Short (6) Percent Change*: -46 Percent Change*: -35 NS

Papules (count)

Baseline counts: 21 (Target) / 23 

(Comparator)

Mid (12) Percent Change*: -45 Percent Change*: -24 0.05

Pustules (count)

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

Mid (12) Percent Change*: -62 Percent Change*: -31 0.05

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

33 Inflammatory (count)

Baseline counts: 9 (Target) / 7 (Comparator)

Short (6) Percent Change*: -68 .0001 Percent Change*: -12

Parallel Mild

N=87 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 C CONTINUOUS: Page 1 of 21

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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

33 Inflammatory (count)

Between P-value: compared to tetra.Baseline 

counts: 9 (Target) / 7 (Comparator)

Mid (8) Percent Change*: -72 .0001 Percent Change*: -12

Parallel Mild

N=87 NS 0.0004

C.01.01 Clindamycin hydrochloride Vehicle

20 Papules (count)

Baseline counts: 25 (Target) / 26 

(Comparator)

Short (6) Percent Change*: -64 Percent Change*: -166

Parallel Mod

N=358 0.15

Pustules (count)

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

Short (6) Percent Change*: -61 Percent Change*: -32 0.018

327 Nodules (count)

Baseline counts: 2 (Target) / 0 (Comparator)

Mid (8) Percent Change*: -50 NS Percent Change*: 500

Parallel Mild/mod

N=18 NS NS

Papules (count)

Baseline counts: 32 (Target) / 31 

(Comparator)

Mid (8) Percent Change*: -43 NS Percent Change*: -23 NS NS

20 Papules change (count)

Baseline counts: 25 (Target) / 26 

(Comparator)

Mid (8) Percent change*: -66 Percent change*: -42

Parallel Mod

N=358 0.0022

327 Pustules (count)

Baseline counts: 2 (Target) / 1 (Comparator)

Mid (8) Percent Change*: -56 NS Percent Change*: -86

Parallel Mild/mod

N=18 NS NS

20 Pustules change (count)

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

Mid (8) Percent change*: -62 Percent change*: -43

Parallel Mod

N=358 0.029

C.01.01 Clindamycin phosphate Vehicle

199 Closed comedones (count)

Baseline counts: 6 (Target) / 8 (Comparator)

Short (3) Percent Change*: 00 NS Percent Change*: -17

Parallel Mild/mod

È N=45 NS NS*

Nodes+cysts (count)

Baseline counts: 1 (Target) / 1 (Comparator)

Short (3) Percent Change*: -17 sig Percent Change*: -50 sig NS

Open comedones (count)

Baseline counts: 9 (Target) / 6 (Comparator)

Short (3) Percent Change*: -09 sig Percent Change*: 03 NS NS*

Papules (count)

Between P-value: no P value given.Baseline 

counts: 21 (Target) / 20 (Comparator)

Short (6) Percent Change*: -39 sig Percent Change*: -37 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 C CONTINUOUS: Page 2 of 21

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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

20 Papules (count)

Baseline counts: 26 (Target) / 26 

(Comparator)

Short (6) Percent Change*: -56 Percent Change*: -166

Parallel Mod

N=358 0.15

Pustules (count)

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

Short (6) Percent Change*: -68 Percent Change*: -32 0.018

199 Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Short (6) Percent Change*: -31 sig Percent Change*: -32

Parallel Mild/mod

È N=45 sig NS

20 Papules change (count)

Baseline counts: 26 (Target) / 26 

(Comparator)

Mid (8) Percent change*: -56 Percent change*: -42

Parallel Mod

N=358 0.0022

Pustules change (count)

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

Mid (8) Percent change*: -72 Percent change*: -43 0.029

199 Closed comedones (count)

Baseline counts: 6 (Target) / 8 (Comparator)

Mid (12) Percent Change*: -39 NS Percent Change*: -34

Parallel Mild/mod

È N=45 NS NS

Nodes+cysts (count)

Baseline counts: 1 (Target) / 1 (Comparator)

Mid (12) Percent Change*: -67 sig Percent Change*: -25 sig NS

Open comedones (count)

Baseline counts: 9 (Target) / 6 (Comparator)

Mid (12) Percent Change*: -63 sig Percent Change*: -17 sig NS

Papules (count)

Baseline counts: 21 (Target) / 20 

(Comparator)

Mid (12) Percent Change*: -68 sig Percent Change*: -51 sig NS

Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Mid (12) Percent Change*: -71 sig Percent Change*: -16 sig 0.021

C.01.01 Clindamycin phosphate (gel) Placebo

99 Papules (count)

Baseline counts: 22 (Target) / 23 

(Comparator)

Short (6) Percent Change*: -36 Percent Change*: -20

Parallel Mod

Í N=135 0.05

Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Short (6) Percent Change*: -39 Percent Change*: -35 NS

Papules (count)

Baseline counts: 22 (Target) / 23 

(Comparator)

Mid (12) Percent Change*: -49 Percent Change*: -24 0.05

 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 C CONTINUOUS: Page 3 of 21

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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

99 Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Mid (12) Percent Change*: -59 Percent Change*: -31

Parallel Mod

Í N=135 0.05

C.01.02 Clindamycin Nicotinamide

305 Inflammatory change (%) Short (4) Percent change: -44 (32.) Percent change: -30 

Parallel Mod (37.)

Í N=76 NS

Severity change (allen-smith %) Short (4) Measure: -27 (37.) Measure: -18 (24.) NS

Inflammatory change (%) Mid (8) Percent change: -43 (41.) Percent change: -60 

(41.)

NS

Severity (allen-smith) Mid (8) Measure: 3 (0.33) Measure: 2 (0.39) NS

Severity change (allen-smith %) Mid (8) Measure: -38 (32.) Measure: -52 (32.) NS

C.01.03 Clindamycin phosphate (lotion) Clindamycin phosphate (gel)

99 Papules (count)

Baseline counts: 21 (Target) / 22 

(Comparator)

Short (6) Percent Change*: -29 Percent Change*: -36

Parallel Mod

Í N=135 0.05

Pustules (count)

Baseline counts: 4 (Target) / 5 (Comparator)

Short (6) Percent Change*: -46 Percent Change*: -39 NS

Papules (count)

Baseline counts: 21 (Target) / 22 

(Comparator)

Mid (12) Percent Change*: -45 Percent Change*: -49 0.05

Pustules (count)

Baseline counts: 4 (Target) / 5 (Comparator)

Mid (12) Percent Change*: -62 Percent Change*: -59 0.05

C.01.03 Clindamycin (gel) Clindamycin (solution)

267 Open comedones (count)

Baseline counts: 8 (Target) / 7 (Comparator)

Short (6) Percent Change*: -37 sig Percent Change*: -39

Parallel Mild

Í N=60 sig NS*

Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Short (6) Percent Change*: -53 sig Percent Change*: -48 sig NS*

Open comedones (count)

Baseline counts: 8 (Target) / 7 (Comparator)

Mid (12) Percent Change*: -68 sig Percent Change*: -61 sig NS*

Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Mid (12) Percent Change*: -75 sig Percent Change*: -75 sig NS*

C.01.03 Clindamycin (lotion) Clindamycin (solution)

 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 C CONTINUOUS: Page 4 of 21

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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

131 Closed comedones (count)

Baseline counts: 57 (Target) / 39 

(Comparator)

Short (6) Percent Change*: -19 Percent Change*: 04

Parallel Mod/sev

È N=70

Open comedones (count) 6

Baseline counts: 10 (Target) / 5 (Comparator)

Short (6) Percent Change*: -22 Percent Change*: 14

Papules (count)

Baseline counts: 45 (Target) / 42 

(Comparator)

Short (6) Percent Change*: -12 Percent Change*: 07

Pustules (count)

Baseline counts: 16 (Target) / 25 

(Comparator)

Short (6) Percent Change*: 04 Percent Change*: 04

Severity (goltz) Short (6) Measure: 2 (0.5) Measure: 2 (0.6) NS*

Closed comedones (count)

Baseline counts: 57 (Target) / 39 

(Comparator)

Mid (12) Percent Change*: -50 Percent Change*: -22

Open comedones (count)

Baseline counts: 10 (Target) / 5 (Comparator)

Mid (12) Percent Change*: -61 Percent Change*: -46

Papules (count)

Baseline counts: 45 (Target) / 42 

(Comparator)

Mid (12) Percent Change*: -30 Percent Change*: -28

Pustules (count)

Baseline counts: 16 (Target) / 25 

(Comparator)

Mid (12) Percent Change*: -27 Percent Change*: -24

Severity (goltz) Mid (12) Measure: 2 (0.5) .01 Measure: 2 (0.6) .01 NS*

C.01.03 Clindamycin (solution) Clindamycin (gel)

267 Open comedones (count)

Baseline counts: 7 (Target) / 8 (Comparator)

Short (6) Percent Change*: -39 sig Percent Change*: -37

Parallel Mild

Í N=60 sig NS*

Pustules (count)

Baseline counts: 4 (Target) / 5 (Comparator)

Short (6) Percent Change*: -48 sig Percent Change*: -53 sig NS*

Open comedones (count)

Baseline counts: 7 (Target) / 8 (Comparator)

Mid (12) Percent Change*: -61 sig Percent Change*: -68 sig NS*

Pustules (count)

Baseline counts: 4 (Target) / 5 (Comparator)

Mid (12) Percent Change*: -75 sig Percent Change*: -75 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 C CONTINUOUS: Page 5 of 21

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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

C.01.03 Clindamycin (solution) Clindamycin (lotion)

131 Closed comedones (count)

Baseline counts: 39 (Target) / 57 

(Comparator)

Short (6) Percent Change*: 04 Percent Change*: -19

Parallel Mod/sev

È N=70

Open comedones (count)

Baseline counts: 5 (Target) / 10 (Comparator)

Short (6) Percent Change*: 14 Percent Change*: -22

Papules (count)

Baseline counts: 42 (Target) / 45 

(Comparator)

Short (6) Percent Change*: 07 Percent Change*: -12

Pustules (count)

Baseline counts: 25 (Target) / 16 

(Comparator)

Short (6) Percent Change*: 04 Percent Change*: 04

Severity (goltz) Short (6) Measure: 2 (0.6) Measure: 2 (0.5) NS*

Closed comedones (count)

Baseline counts: 39 (Target) / 57 

(Comparator)

Mid (12) Percent Change*: -22 Percent Change*: -50

Open comedones (count)

Baseline counts: 5 (Target) / 10 (Comparator)

Mid (12) Percent Change*: -46 Percent Change*: -61

Papules (count)

Baseline counts: 42 (Target) / 45 

(Comparator)

Mid (12) Percent Change*: -28 Percent Change*: -30

Pustules (count)

Baseline counts: 25 (Target) / 16 

(Comparator)

Mid (12) Percent Change*: -24 Percent Change*: -27

Severity (goltz) Mid (12) Measure: 2 (0.6) .01 Measure: 2 (0.5) .01 NS*

C.01.03 Clindamycin hydrochloride Clindamycin phosphate

20 Papules (count)

Baseline counts: 25 (Target) / 26 

(Comparator)

Short (6) Percent Change*: -64 Percent Change*: -56

Parallel Mod

N=358 0.15

Pustules (count)

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

Short (6) Percent Change*: -61 Percent Change*: -68 0.018

 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 C CONTINUOUS: Page 6 of 21

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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

20 Papules change (count)

Baseline counts: 25 (Target) / 26 

(Comparator)

Mid (8) Percent change*: -66 Percent change*: -56

Parallel Mod

N=358 0.0022

Pustules change (count)

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

Mid (8) Percent change*: -62 Percent change*: -72 0.029

143 Nodules (count)

Baseline counts: 11 (Target) / 9 (Comparator)

Mid (12) Percent Change*: -100 Percent Change*: -78

Parallel split face Sev

È N=42

Papules (count)

Baseline counts: 14 (Target) / 14 

(Comparator)

Mid (12) Percent Change*: 221 Percent Change*: 214

Pustules (count)

Baseline counts: 214 (Target) / 192 

(Comparator)

Mid (12) Percent Change*: -87 Percent Change*: -88

C.01.03 Clindamycin phosphate Clindamycin hydrochloride

20 Papules (count)

Baseline counts: 26 (Target) / 25 

(Comparator)

Short (6) Percent Change*: -56 Percent Change*: -64

Parallel Mod

N=358 0.15

Pustules (count)

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

Short (6) Percent Change*: -68 Percent Change*: -61 0.018

Papules change (count)

Baseline counts: 26 (Target) / 25 

(Comparator)

Mid (8) Percent change*: -56 Percent change*: -66 0.0022

Pustules change (count)

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

Mid (8) Percent change*: -72 Percent change*: -62 0.029

143 Nodules (count)

Baseline counts: 9 (Target) / 11 (Comparator)

Mid (12) Percent Change*: -78 Percent Change*: -100

Parallel split face Sev

È N=42

Papules (count)

Baseline counts: 14 (Target) / 14 

(Comparator)

Mid (12) Percent Change*: 214 Percent Change*: 221 NS

Pustules (count)

Baseline counts: 192 (Target) / 214 

(Comparator)

Mid (12) Percent Change*: -88 Percent Change*: -87

C.01.03 Clindamycin phosphate (gel) Clindamycin phosphate (lotion)

 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 C CONTINUOUS: Page 7 of 21

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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

99 Papules (count)

Baseline counts: 22 (Target) / 21 

(Comparator)

Short (6) Percent Change*: -36 Percent Change*: -29

Parallel Mod

Í N=135 0.05

Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Short (6) Percent Change*: -39 Percent Change*: -46 NS

Papules (count)

Baseline counts: 22 (Target) / 21 

(Comparator)

Mid (12) Percent Change*: -49 Percent Change*: -45 0.05

Pustules (count)

Baseline counts: 5 (Target) / 4 (Comparator)

Mid (12) Percent Change*: -59 Percent Change*: -62 0.05

C.01.04 Clindamycin Erythromycin

326 Closed comedones (count)

Count location: Both sides. Baseline counts: 

28 (Target) / 22 (Comparator)

Short (4) Percent Change*: -24 Percent Change*: -18

Parallel Mod/sev

N=72 NS*

Closed comedones (count) Short (4) Percent Change*: -24 Percent Change*: -18 NS*

303 Inflammatory (count)

Count location: Entire face. Baseline counts: 

20 (Target) / 22 (Comparator)

Short (4) Percent Change*: -40 Percent Change*: -35

Parallel Mod

N=178 Duncan

326 Non-inflammatory (count)

Count location: Both sides. Baseline counts: 

47 (Target) / 58 (Comparator)

Short (4) Percent Change*: -24 Percent Change*: -38

Parallel Mod/sev

N=72 NS NS*

303 Non-inflammatory (count)

Count location: Entire face. Baseline counts: 

56 (Target) / 53 (Comparator)

Short (4) Percent Change*: -37 Percent Change*: -27

Parallel Mod

N=178 Duncan

326 Non-inflammatory (count)

Count location: Both sides. Baseline counts: 

47 (Target) / 58 (Comparator)

Short (4) Percent Change*: -24 Percent Change*: -38

Parallel Mod/sev

N=72 NS NS*

244 Papules change (%) Short (4) Percent change: -28 Percent change: -33

Parallel Mild/mod

È N=120

Pustules change (%) Short (4) Percent change: -37 Percent change: -61

326 Total inflammatory (count)

Count location: Both sides. Baseline counts: 

23 (Target) / 22 (Comparator)

Short (4) Percent Change*: -31 Percent Change*: -22

Parallel Mod/sev

N=72 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 C CONTINUOUS: Page 8 of 21

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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

326 Total inflammatory (count)

Count location: Both sides. Baseline counts: 

23 (Target) / 22 (Comparator)

Short (4) Percent Change*: -31 Percent Change*: -22

Parallel Mod/sev

N=72 NS*

244 Comedones change (%) Mid (8) Percent change: -10 Percent change: -15

Parallel Mild/mod

È N=120

Dryness change (score) Mid (8) Measure: 0 Measure: 0

Dryness change (score) Mid (8) Measure: 0 Measure: 0

Erythema change (score) Mid (8) Measure: 0 Measure: 0

Inflammatory change (%) Mid (8) Percent change: -37 Percent change: -49

Total lesions change (%) Mid (8) Percent change: -27 Percent change: -31

326 Closed comedones (count)

Count location: Both sides. Baseline counts: 

28 (Target) / 22 (Comparator)

Mid (12) Percent Change*: -26 .0006 Percent Change*: 00

Parallel Mod/sev

N=72 NS 0.0213

Closed comedones (count) Mid (12) Percent Change*: -26 .0006 Percent Change*: 00 NS 0.0213

303 Inflammatory (count)

Count location: Entire face. Baseline counts: 

20 (Target) / 22 (Comparator)

Mid (12) Percent Change*: -59 .001 Percent Change*: -62

Parallel Mod

N=178 .001 Duncan

326 Nodes+cysts (count)

Count location: Both sides. Baseline counts: 2 

(Target) / 2 (Comparator)

Mid (12) Percent Change*: -41 NS Percent Change*: -40

Parallel Mod/sev

N=72 NS NS

Nodes+cysts (count) Mid (12) Percent Change*: -41 NS Percent Change*: -40 NS NS

Non-inflammatory (count)

Count location: Both sides. Baseline counts: 

47 (Target) / 58 (Comparator)

Mid (12) Percent Change*: 00 .03 Percent Change*: 00 NS NS

303 Non-inflammatory (count)

Count location: Entire face. Baseline counts: 

56 (Target) / 53 (Comparator)

Mid (12) Percent Change*: -39 .001 Percent Change*: -43

Parallel Mod

N=178 .001 Duncan

326 Non-inflammatory (count)

Count location: Both sides. Baseline counts: 

47 (Target) / 58 (Comparator)

Mid (12) Percent Change*: 00 .03 Percent Change*: 00

Parallel Mod/sev

N=72 NS NS

Open comedones (count)

Count location: Both sides. Baseline counts: 

20 (Target) / 37 (Comparator)

Mid (12) Percent Change*: -55 NS Percent Change*: -52 NS 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 C CONTINUOUS: Page 9 of 21

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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

326 Open comedones (count)

Count location: Both sides. Baseline counts: 

20 (Target) / 37 (Comparator)

Mid (12) Percent Change*: -55 NS Percent Change*: -52

Parallel Mod/sev

N=72 NS NS

Total inflammatory (count)

Count location: Both sides. Baseline counts: 

23 (Target) / 22 (Comparator)

Mid (12) Percent Change*: -01 .0001 Percent Change*: 00 .0001 NS

Total inflammatory (count) Mid (12) Percent Change*: -01 .0001 Percent Change*: 00 .0001 NS

Total lesions (count)

Count location: Both sides. 

Mid (12) Raw count: 37 .003 Raw count: 45 .01 NS

Total lesions (count) Mid (12) Raw count: 37 .003 Raw count: 45 .01 NS

C.01.04 Clindamycin phosphate Erythromycin

158 Comedones (count)

Baseline counts: 34 (Target) / 29 

(Comparator)

Short (4) Percent Change*: -05 Percent Change*: -11

Parallel Mod

È N=120

Cysts change (%) Short (4) Percent change: 0 Percent change: 0

Inflammatory (count) Short (4) Raw count: 18 Raw count: 15

Total lesions change (%) Short (4) Percent change: 50 Percent change: 41

Comedones change (%)

Count location: Face. 

Mid (8) Percent change: 15 Percent change: -15 NS

Cysts change (%) Mid (8) Percent change: 0 Percent change: 0

Inflammatory change (%)

Count location: Face. 

Mid (8) Percent change: -9 Percent change: -39 0.003

Overall change/investigator Mid (8) Measure: 56 Measure: 80 0.012

Total lesions change (%)

Count location: Face. 

Mid (8) Percent change: -9 Percent change: -29

Total lesions change (count)

Baseline counts: 57 (Target) / 53 

(Comparator)

Mid (8) Percent change*: 85 Percent change*: 75 0.0183

C.01.05 Clindamycin Tetracycline

291 Open comedones change (count)

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

Short (6) Percent change*: -30 Percent change*: 70

Parallel Mild

È N=92 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 C CONTINUOUS: Page 10 of 21

ÈÍ
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

291 Papules change (count)

Baseline counts: 13 (Target) / 13 

(Comparator)

Short (6) Percent change*: -61 Percent change*: -60

Parallel Mild

È N=92 NS

Pustules change (count)

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

Short (6) Percent change*: -64 Percent change*: -56 NS

Open comedones change (count)

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

Mid (8) Percent change*: -28 Percent change*: 57 NS

Papules change (count)

Baseline counts: 13 (Target) / 13 

(Comparator)

Mid (8) Percent change*: -71 Percent change*: -63 NS

Pustules change (count ) Mid (8) Measure: -4 Measure: -4 NS

C.01.05 Clindamycin Tetracycline hydrochloride

261 Total lesions (count)

Count location: Both sides. 

Short (6) Raw count: 7 Raw count: 13

Parallel Mild/mod

Í N=52

Total lesions (count) Mid (8) Raw count: 6 Raw count: 14

C.01.06 Clindamycin Benzoyl Peroxide

329 Comedones (count)

Count location: Unspecified. Baseline counts: 

61 (Target) / 43 (Comparator)

Short (6) Percent Change*: -02 Percent Change*: -19

Parallel Mod

N=79

Cysts (count)

Count location: Unspecified. 

Short (6) Raw count: 1 Raw count: 3

Irritancy (score)

Between P-value: C < B.

Short (6) Measure: 0 Measure: 1 NS

Papules (count)

Count location: Unspecified. Baseline counts: 

21 (Target) / 16 (Comparator)

Short (6) Percent Change*: -38 Percent Change*: -19

Pustules (count)

Count location: Unspecified. Baseline counts: 

8 (Target) / 8 (Comparator)

Short (6) Percent Change*: -25 Percent Change*: -63

Severity change (michaelsson %)

Count location: Unspecified. 

Short (6) Measure: -36 Measure: -42

 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 C CONTINUOUS: Page 11 of 21

ÈÍ
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

329 Comedones (count)

Count location: Unspecified. Baseline counts: 

61 (Target) / 43 (Comparator)

Mid (10) Percent Change*: -15 Percent Change*: -19

Parallel Mod

N=79

Cysts (count)

Count location: Unspecified. 

Mid (10) Raw count: 0 Raw count: 1

Irritancy (score)

Between P-value: C < B.

Mid (10) Measure: 0 Measure: 1 NS

Papules (count)

Count location: Unspecified. Baseline counts: 

21 (Target) / 16 (Comparator)

Mid (10) Percent Change*: -45 Percent Change*: -59

Pustules (count)

Count location: Unspecified. Baseline counts: 

8 (Target) / 8 (Comparator)

Mid (10) Percent Change*: -44 Percent Change*: -72

Severity change (michaelsson %)

Count location: Unspecified. 

Mid (10) Measure: -47 Measure: -59 0.05

C.01.06 Clindamycin phosphate Benzoyl peroxide

324 Local reactions/Oiliness Short (1. Measure: 1 (1.2) Measure: 1 (1.2)

Parallel Mod

È N=60 0.05

Inflammatory change (%) Short (4) Percent change: -26 (6.6) .01 Percent change: -28 

(6.4)

.01 NS

Local reactions/Dryness Short (4) Measure: 1 (2.7) Measure: 1 (2.7) 0.05

Local reactions/Erythema Short (4) Measure: 1 Measure: 1 NS

Local reactions/Oiliness Short (4) Measure: 1 (2.7) Measure: 1 (2.7) 0.05

Local reactions/Peeling Short (4) Measure: 0 (3.1) Measure: 1 (3.1) 0.05

Non-inflammatory change (%) Short (4) Percent change: -29 (12.) .002 Percent change: -32 

(18.)

.001 NS

Total lesions change (%) Short (4) Percent change: -27 (16.) .001 Percent change: -31 

(23.)

.001 NS

Inflammatory change (%) Mid (12) Percent change: -28 (7.6) .006 Percent change: -52 

(11.)

.02 NS

Local reactions/Dryness Mid (12) Measure: 1 (1.2) Measure: 2 (1.2) NS

Local reactions/Erythema Mid (12) Measure: 1 Measure: 1 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 C CONTINUOUS: Page 12 of 21

ÈÍ
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

324 Local reactions/Peeling Mid (12) Measure: 1 (2.4) Measure: 1 (2.4)

Parallel Mod

È N=60 0.05

Non-inflammatory change (%) Mid (12) Percent change: -37 (16.) .002 Percent change: -63 

(35.)

.001 0.001

Total lesions change (%) Mid (12) Percent change: -34 (21.) .001 Percent change: -60 

(44.)

.001 NS

C.02.03 Clindamycin + Benzoyl Peroxide Benzoyl Peroxide

329 Comedones (count)

Count location: Unspecified. Baseline counts: 

47 (Target) / 43 (Comparator)

Short (6) Percent Change*: -32 Percent Change*: -19

Parallel Mod

N=79

Cysts (count)

Count location: Unspecified. 

Short (6) Raw count: 1 Raw count: 3

Irritancy (score)

Between P-value: C + B < B.

Short (6) Measure: 0 Measure: 1 NS

Papules (count)

Count location: Unspecified. Baseline counts: 

19 (Target) / 16 (Comparator)

Short (6) Percent Change*: -32 Percent Change*: -19

Pustules (count)

Count location: Unspecified. Baseline counts: 

10 (Target) / 8 (Comparator)

Short (6) Percent Change*: -60 Percent Change*: -63

Severity change (Michaelsson %)

Count location: Unspecified. 

Short (6) Measure: -50 Measure: -42

Comedones (count)

Count location: Unspecified. Baseline counts: 

47 (Target) / 43 (Comparator)

Mid (10) Percent Change*: -47 Percent Change*: -19

Cysts (count)

Count location: Unspecified. 

Mid (10) Raw count: 1 Raw count: 1

Irritancy (score)

Between P-value: C + B < B.

Mid (10) Measure: 0 Measure: 1 NS

Papules (count)

Count location: Unspecified. Baseline counts: 

19 (Target) / 16 (Comparator)

Mid (10) Percent Change*: -63 Percent Change*: -59

 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 C CONTINUOUS: Page 13 of 21

ÈÍ
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

329 Pustules (count)

Count location: Unspecified. Baseline counts: 

10 (Target) / 8 (Comparator)

Mid (10) Percent Change*: -79 Percent Change*: -72

Parallel Mod

N=79

Severity change (michaelsson %)

Count location: Unspecified. 

Mid (10) Measure: -65 Measure: -59 0.05

C.03.01 Erythromycin Vehicle

274 Closed comedones (count)

Baseline counts: 8 (Target) / 3 (Comparator)

Short (4) Percent Change*: -121 Percent Change*: -133

Parallel Mild/mod

È N=187 NS

89 Closed comedones change (%)

Count location: Face. 

Short (4) Percent change: -10 Percent change: -20

Parallel Mod/sev

N=253 NS

205 Inflammatory (count)

Baseline counts: 25 (Target) / 24 

(Comparator)

Short (4) Percent Change*: -21 Percent Change*: -09

Parallel Mild/mod

È N=225 0.004

274 Open comedones (count)

Baseline counts: 17 (Target) / 15 

(Comparator)

N=187 Short (4) Percent Change*: -133 Percent Change*: -127 NS

89 Open comedones change (%)

Count location: Face. 

Short (4) Percent change: -22 Percent change: -18

Parallel Mod/sev

N=253 NS

274 Papules (count)

Baseline counts: 16 (Target) / 16 

(Comparator)

Short (4) Percent Change*: -129 Percent Change*: -113

Parallel Mild/mod

È N=187 0.05

89 Papules change (%)

Count location: Face. 

Short (4) Percent change: -45 Percent change: -23

Parallel Mod/sev

N=253 NS

285 Papules change (%)

Count location: Face unspecified. 

N=26 Short (4) Percent change: -55 Percent change: -27 0.01

274 Pustules (count)

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

Short (4) Percent Change*: -137 Percent Change*: -142

Parallel Mild/mod

È N=187 NS

89 Pustules change (%)

Count location: Face. 

Short (4) Percent change: -52 Percent change: -24

Parallel Mod/sev

N=253 NS

285 Pustules change (%)

Count location: Face unspecified. 

N=26 Short (4) Percent change: -11 Percent change: -67

 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 C CONTINUOUS: Page 14 of 21

ÈÍ
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

205 Severity (cook ) Short (4) Measure: 3 (1.) Measure: 4 (1.)

Parallel Mild/mod

È N=225 0.003

89 Total lesions change (%)

Count location: Face. 

Short (4) Percent change: -30 Percent change: -20

Parallel Mod/sev

N=253 NS

184 Inflammatory (group count)

Count location: Entire (with estimate). 

Short (6) Percent Change*: -99 Percent Change*: -99

Parallel Mod

È N=175 0.029

157 Severity change (plewig) Short (6) Measure: -2 (0.7) Measure: -1 (0.6)

Parallel split face 

Mod/sev

N=29 NS*

274 Closed comedones (count)

Baseline counts: 8 (Target) / 3 (Comparator)

Mid (8) Percent Change*: -122 Percent Change*: -185

Parallel Mild/mod

È N=187 NS

Open comedones (count)

Baseline counts: 17 (Target) / 15 

(Comparator)

Mid (8) Percent Change*: -144 Percent Change*: -131 0.01

Papules (count)

Baseline counts: 16 (Target) / 16 

(Comparator)

Mid (8) Percent Change*: -139 Percent Change*: -126 0.05

Pustules (count)

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

Mid (8) Percent Change*: -149 Percent Change*: -132 0.05

89 Closed comedones change (%)

Count location: Face. 

Mid (12) Percent change: -25 Percent change: -20

Parallel Mod/sev

N=253 NS

205 Inflammatory (count)

Baseline counts: 25 (Target) / 24 

(Comparator)

Mid (12) Percent Change*: -46 Percent Change*: -19

Parallel Mild/mod

È N=225 0.001

184 Inflammatory (group count)

Count location: Entire (with estimate). 

Mid (12) Percent Change*: -99 Percent Change*: -99

Parallel Mod

N=175 0.001

89 Open comedones change (%)

Count location: Face. 

Mid (12) Percent change: -30 Percent change: -20

Parallel Mod/sev

N=253 NS

285 Papules change (%)

Count location: Face unspecified. 

N=26 Mid (12) Percent change: -71 Percent change: -43 0.01

89 Papules change (%)

Count location: Face. 

N=253 Mid (12) Percent change: -55 Percent change: -45 0.025

 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 C CONTINUOUS: Page 15 of 21

ÈÍ
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

285 Pustules change (%)

Count location: Face unspecified. 

Mid (12) Percent change: -78 Percent change: -53

Parallel Mod/sev

N=26

89 Pustules change (%)

Count location: Face. 

N=253 Mid (12) Percent change: -64 Percent change: -50 NS

205 Severity change (cook %) Mid (12) Measure: -40 (33.) Measure: -22 (36.)

Parallel Mild/mod

È N=225 NS*

89 Total lesions change (%)

Count location: Face. 

Mid (12) Percent change: -40 Percent change: -30

Parallel Mod/sev

N=253 0.01

C.03.01 Erythromycin (topical) Placebo

39 Inflammatory (counts)

Count location: Unspecified. Between P-value: 

E<BP.

Short (4) Measure: 12 (9.) Measure: 19 (14.)

Parallel Mild/mod/sev

N=94 0.01

Non-inflammatory (count)

Count location: Unspecified. Between P-value: 

E<BP.Baseline counts: 33 (Target) / 32 

(Comparator)

Short (4) Percent Change*: -08 Percent Change*: -05 NS*

Severity (Leeds)

Count location: Unspecified. 

Short (4) Measure: 1 (0.33) Measure: 1 (0.38) 0.01

Total Lesions (count)

Count location: Unspecified. Between P-value: 

E>P.Baseline counts: 61 (Target) / 59 

(Comparator)

Short (4) Percent Change*: -16 Percent Change*: 02 0.01

Inflammatory (count)

Count location: Unspecified. Between P-value: 

E>P.Baseline counts: 20 (Target) / 20 

(Comparator)

Mid (8) Percent Change*: -34 Percent Change*: -17 0.01

Non-inflammatory (count)

Count location: Unspecified. Between P-value: 

E<BP.Baseline counts: 33 (Target) / 32 

(Comparator)

Mid (8) Percent Change*: -10 Percent Change*: -02 NS*

Severity (Leeds)

Count location: Unspecified. 

Mid (8) Measure: 1 (0.27) Measure: 1 (0.32) 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 C CONTINUOUS: Page 16 of 21

ÈÍ
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

39 Total Lesions (count)

Count location: Unspecified. Between P-value: 

E>P.Baseline counts: 61 (Target) / 59 

(Comparator)

Mid (8) Percent Change*: -20 Percent Change*: 00

Parallel Mild/mod/sev

N=94 0.01

C.03.025 Erythromycin (topical) Benzoyl Peroxide

39 Inflammatory (counts)

Count location: Unspecified. Between P-value: 

E<BP.

Short (4) Measure: 12 (9.) Measure: 13 (9.)

Parallel Mild/mod/sev

N=94 0.01

Non-inflammatory (count)

Count location: Unspecified. Between P-value: 

E<BP.Baseline counts: 33 (Target) / 33 

(Comparator)

Short (4) Percent Change*: -08 Percent Change*: -24 NS*

Severity (Leeds)

Count location: Unspecified. 

Short (4) Measure: 1 (0.33) Measure: 1 (0.27) 0.01

Total Lesions (count)

Count location: Unspecified. Between P-value: 

E>P.Baseline counts: 61 (Target) / 63 

(Comparator)

Short (4) Percent Change*: -16 Percent Change*: -24 0.01

Inflammatory (count)

Count location: Unspecified. Between P-value: 

E>P.Baseline counts: 20 (Target) / 20 

(Comparator)

Mid (8) Percent Change*: -34 Percent Change*: -39 0.01

Non-inflammatory (count)

Count location: Unspecified. Between P-value: 

E<BP.Baseline counts: 33 (Target) / 33 

(Comparator)

Mid (8) Percent Change*: -10 Percent Change*: -29 NS*

Severity (Leeds)

Count location: Unspecified. 

Mid (8) Measure: 1 (0.27) Measure: 0 (0.33) 0.001

Total Lesions (count)

Count location: Unspecified. Between P-value: 

E>P.Baseline counts: 61 (Target) / 63 

(Comparator)

Mid (8) Percent Change*: -20 Percent Change*: -31 0.01

C.04.01 Fusiden Vehicle

 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 C CONTINUOUS: Page 17 of 21

ÈÍ
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

151 Comedones (count)

Count location: 5 cm diameter. Baseline 

counts: 7 (Target) / 8 (Comparator)

Short (6) Percent Change*: -16 Percent Change*: -31

Parallel Mild/mod

N=79 NS

Inflammatory (count)

Count location: 5 cm diameter. Baseline 

counts: 11 (Target) / 10 (Comparator)

Short (6) Percent Change*: -62 Percent Change*: -36 0.001

C.04.01 Fusidic acid Placebo

315 Inflammatory change (%) Short (4) Percent change: -13 (18.) Percent change: -20 

Parallel (12.)

N=56 NS

Non-inflammatory change (%) Short (4) Percent change: 0 (20.) Percent change: 17 

(20.)

NS

Severity change (leeds) Short (4) Measure: -20 (12.) Measure: -25 (10.) NS

Inflammatory change (%) Mid (12) Percent change: -19 (25.) Percent change: -28 

(18.)

NS

Non-inflammatory change (%) Mid (12) Percent change: -12 (20.) Percent change: 17 

(30.)

NS

Severity change (leeds) Mid (12) Measure: -37 (15.) Measure: -30 (15.) NS

C.05.005 Meclocycline Vehicle

194 Inflammatory change (median %)

Count location: Face. 

Short (5) Measure: -49 Measure: -26

Parallel Mod/sev

N=134 0.001

Comedones (count)

Count location: Face. Baseline counts: 88 

(Target) / 90 (Comparator)

Mid (11) Percent Change*: -32 Percent Change*: -100

Inflammatory change (median %)

Count location: Face. 

Mid (11) Measure: -57 Measure: -22 0.001

C.05.01 Meclocycline Benzoyl peroxide

30 Comedones (count)

Count location: Face. Baseline counts: 12 

(Target) / 10 (Comparator)

Short (6) Percent Change*: -26 Percent Change*: -58

Parallel Mod

È N=102

 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 C CONTINUOUS: Page 18 of 21

ÈÍ
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

30 Papules (count)

Count location: Face. Baseline counts: 21 

(Target) / 21 (Comparator)

Short (6) Percent Change*: -24 Percent Change*: -48

Parallel Mod

È N=102

Pustules (count)

Count location: Face. Baseline counts: 9 

(Target) / 9 (Comparator)

Short (6) Percent Change*: -28 Percent Change*: -56

Comedones (count)

Count location: Face. Baseline counts: 12 

(Target) / 10 (Comparator)

Mid (10) Percent Change*: -30 Percent Change*: -68 0.01

Papules (count)

Count location: Face. Baseline counts: 21 

(Target) / 21 (Comparator)

Mid (10) Percent Change*: -33 Percent Change*: -62 NS

Pustules (count)

Count location: Face. Baseline counts: 9 

(Target) / 9 (Comparator)

Mid (10) Percent Change*: -34 Percent Change*: -58 NS

C.06.01 Metronidazole Placebo

328 Inflammatory (count)

Baseline counts: 24 (Target) / 23 

(Comparator)

Short (4) Percent Change*: -06 NS Percent Change*: -03

Parallel Mild/mod

È N=96 NS

Non-inflammatory (count)

Baseline counts: 6 (Target) / 8 (Comparator)

Short (4) Percent Change*: 146 NS Percent Change*: 03 NS NS

Inflammatory (count)

Baseline counts: 24 (Target) / 23 

(Comparator)

Mid (12) Percent Change*: -32 NS Percent Change*: -25 NS NS

Non-inflammatory (count)

Baseline counts: 6 (Target) / 8 (Comparator)

Mid (12) Percent Change*: -18 NS Percent Change*: -36 NS NS

Tetracycline (topical) + placebo 

(oral)

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

10 Severity (anderson)

Count location: Butterfly. 

Short (6) Measure: 3 NS Measure: 4

Parallel Mod

N=60 NS NS

Tetracycline hydrochloride 

(topical) + placebo (or

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

 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 C CONTINUOUS: Page 19 of 21

ÈÍ
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

23 Severity change (cook)

Count location: Entire face-(photos). 

Short (6) Measure: -1 (0.85) Measure: 0 (1.)

Parallel Mod

È N=75 0.05

Severity change (cook)) Long (13 Measure: -1 (1.4) Measure: -1 (1.2) 0.05

Tetracycline hydrochloride 

(topical) + placebo

C.08.01 Placebo + placebo

313 Severity (cook)

Count location: Face. Between P-value: with 

respect to oral.

Short (4) Measure: 3 .05 Measure: 4

Parallel Mild/mod

È N=149 NS NS

Severity (cook)

Count location: Face. Between P-value: with 

respect to oral.

Mid (12) Measure: 2 .05 Measure: 3 NS NS

Tetracycline (topical) + placebo 

(oral)

Benzoyl peroxide + placebo 

(oral)

C.08.03

255 Back severity (leeds)

Count location: Back. 

Mid (12) Measure: 0 (0.47) NS Measure: 0 (0.41)

Parallel Mod

N=69 NS NS

Chest severity (leeds)

Count location: Chest. 

Mid (12) Measure: 0 (0.26) NS Measure: 0 (0.4) NS NS

Face severity (leeds)

Count location: Face. 

Mid (12) Measure: 0 .01 Measure: 1 .001 NS

Inflammatory (count)

Baseline counts: 65 (Target) / 57 

(Comparator)

Mid (12) Percent Change*: -35 .02 Percent Change*: -42 .001 NS

Non-inflammatory (count) Mid (12) Raw count: 43 .003 Raw count: 31 .001 NS

C.09.01 Triclosan Vehicle

114 Inflammatory (adjusted count)

Count location: Entire face. 

Short (4) Raw count: 14 (11.) Raw count: 16 (11.)

Parallel Mild/mod

Í N=72 NS

Inflammatory (score) Short (4) Measure: 2 Measure: 2 NS

Non-inflammatory (count) Short (4) Raw count: 37 (11.) Raw count: 43 (11.) NS 0.05

Overall change/patient (vas) Short (4) Measure: 2 Measure: 1

 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 C CONTINUOUS: Page 20 of 21

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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

114 Inflammatory (count)

Count location: Entire face. Between P-value: 

with respect to vehicle.

Mid (8) Raw count: 11 (11.) Raw count: 16 (11.)

Parallel Mild/mod

Í N=72 0.05

Inflammatory (score)

Count location: Entire face. 

Mid (8) Measure: 1 Measure: 2 NS

Non-inflammatory (count) Mid (8) Raw count: 34 (11.) .05 Raw count: 41 (11.) NS 0.01

Overall change/patient (vas) Mid (8) Measure: 3 Measure: 2

C.09.03 Triclosan + propylene phenoxetol Vehicle

114 Inflammatory (adjusted count)

Count location: Entire face. 

Short (4) Raw count: 14 (9.) Raw count: 16 (11.)

Parallel Mild/mod

Í N=72 NS

Inflammatory (score) Short (4) Measure: 2 Measure: 2 NS

Non-inflammatory (count) Short (4) Raw count: 35 (9.) .01 Raw count: 43 (11.) NS NS*

Overall change/patient (vas) Short (4) Measure: 2 Measure: 1

Inflammatory (count)

Count location: Entire face. Between P-value: 

with respect to vehicle.

Mid (8) Raw count: 12 (9.) Raw count: 16 (11.) 0.05

Inflammatory (score)

Count location: Entire face. 

Mid (8) Measure: 1 Measure: 2 NS

Non-inflammatory (count) Mid (8) Raw count: 34 (9.) .05 Raw count: 41 (11.) NS 0.005

Overall change/patient (vas) Mid (8) Measure: 3 Measure: 2

 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 C CONTINUOUS: Page 21 of 21

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