Evidence Table H2. CONTINUOUS outcomes for class ANTI-BACTERIAL (ORAL).

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

H.01.01 Clindamycin Vehicle

56 Comedones change (%) Short (6) Percent change: -48 Percent change: -22

Parallel Mod/sev

N=98 0.05

Pustules change (%) Short (6) Percent change: -70 Percent change: -38 0.01

Comedones change (%) Mid (10) Percent change: -55 Percent change: -35 NS

Pustules change (%) Mid (10) Percent change: -78 Percent change: -48 0.01

Comedones change (%) Long (13 Percent change: -48 Percent change: -22 0.05

Pustules change (%) Long (13 Percent change: -80 Percent change: -28 0.01

H.01.02 Clindamycin Tetracycline

265 Comedones (count)

Baseline counts: 38 (Target) / 36 

(Comparator)

Short (4) Percent Change*: -32 Percent Change*: -42

Parallel Mod

È N=48

Overall change/physician (rating) Short (4) Measure: 2 Measure: 2

Pustules (count)

Baseline counts: 27 (Target) / 20 

(Comparator)

Short (4) Percent Change*: -56 Percent Change*: -75

Severity (panzer) Short (4) Measure: 2 Measure: 1

Comedones (count)

Baseline counts: 38 (Target) / 36 

(Comparator)

Mid (8) Percent Change*: -47 Percent Change*: -64

Overall change/physician (rating) Mid (8) Measure: 2 Measure: 2

Pustules (count)

Baseline counts: 27 (Target) / 20 

(Comparator)

Mid (8) Percent Change*: -67 Percent Change*: -90

Severity (panzer) Mid (8) Measure: 2 Measure: 1

H.02.01 Demethylchlortetracycline Placebo

312 Overall change/patient (score) Short (4) Measure: 4 (3.6) Measure: 3 (4.8)

Parallel Mild/mod/sev

È N=66 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 H CONTINUOUS: Page 1 of 15

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

312 Severity change/photo (score)

Count location: Entire face. 

Short (4) Measure: 1 (2.5) Measure: 1 (2.4)

Parallel Mild/mod/sev

È N=66 NS

H.02.02 Demethylchlortetracycline Phenethicillin

312 Overall change/patient (score) Short (4) Measure: 4 (3.6) Measure: 3 (4.8)

Parallel Mild/mod/sev

È N=66 NS

Severity change/photo (score)

Count location: Entire face. 

Short (4) Measure: 1 (2.5) Measure: 1 (3.1) NS

H.03.01 Doxycycline Placebo

273 Total inflammatory [phase i] (count)

Baseline counts: 14 (Target) / 13 

(Comparator)

Short (4) Percent Change*: -36 .001 Percent Change*: 12

Cross-over Mild

Í N=62 NS

Total inflammatory [phase ii] (count)

Baseline counts: 12 (Target) / 12 

(Comparator)

Short (4) Percent Change*: -24 .05 Percent Change*: 02 NS

H.03.02 Doxycycline Fusidic acid cream

1 Total lesions (count)

Count location: Half face. 

Short (6) Raw count: 4 (10.) .001 Raw count: 5 (7.)

Parallel Mild/mod

È N=110 .001 NS*

Total lesions (count) Mid (10) Raw count: 4 (10.) .001 Raw count: 4 (7.) .001 NS*

H.03.03 Doxycycline + placebo Erythromycin stearate + placebo

25 Inflammatory change (%)

Count location: Entire face. 

Short (6) Percent change: 16 .001 Percent change: 15

Parallel Mod

È N=56 .001 NS

Severity (kligman) Short (6) Measure: 1 Measure: 1

H.03.04 Doxycycline Minocycline

311 Severity change (smit) Mid (12) Measure: 22 (10.) Measure: 23 (15.)

Parallel Mild/mod

N=18 NS

H.03.04 Doxycycline + placebo Minocycline + placebo

257 Closed comedones (count)

Baseline counts: 21 (Target) / 18 

(Comparator)

Short (4) Percent Change*: -12 Percent Change*: -17

Parallel Mod/sev

N=79 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 H CONTINUOUS: Page 2 of 15

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

257 Open comedones (count)

Baseline counts: 24 (Target) / 24 

(Comparator)

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

Parallel Mod/sev

N=79 NS*

Papules (count)

Baseline counts: 31 (Target) / 35 

(Comparator)

Short (4) Percent Change*: -45 Percent Change*: -37 NS*

Pustules (count)

Baseline counts: 13 (Target) / 20 

(Comparator)

Short (4) Percent Change*: -46 Percent Change*: -50 NS*

Total lesions (count)

Baseline counts: 90 (Target) / 98 

(Comparator)

Short (4) Percent Change*: -31 Percent Change*: -34 NS*

Closed comedones (count)

Baseline counts: 21 (Target) / 18 

(Comparator)

Mid (12) Percent Change*: -41 Percent Change*: -44 NS*

Open comedones (count)

Baseline counts: 24 (Target) / 24 

(Comparator)

Mid (12) Percent Change*: -38 Percent Change*: -29 NS*

Papules (count)

Baseline counts: 31 (Target) / 35 

(Comparator)

Mid (12) Percent Change*: -61 Percent Change*: -67 NS*

Pustules (count)

Baseline counts: 13 (Target) / 20 

(Comparator)

Mid (12) Percent Change*: -62 Percent Change*: -60 NS*

Total lesions (count)

Baseline counts: 90 (Target) / 98 

(Comparator)

Mid (12) Percent Change*: -44 Percent Change*: -49 NS*

H.03.04 Doxycyline Minocyline

155 Cysts change (%)

Count location: Neck anterior to sternomastoid 

muscles and face, e. 

Mid (12) Percent change: -89 Percent change: -81

Parallel Mild/mod/sev

N=43 NS

Nodules change (%) Mid (12) Percent change: -73 Percent change: -72 NS

Papules changes (%) Mid (12) Percent change: -67 Percent change: -67 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 H CONTINUOUS: Page 3 of 15

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

155 Pustules change (%)

Count location: Neck anterior to sternomastoid 

muscles and face, e. 

Mid (12) Percent change: -84 Percent change: -82

Parallel Mild/mod/sev

N=43 NS

Severity change (% Wright) Mid (12) Measure: -66 Measure: -68 NS

Total lesions (%) Mid (12) Percent change: -59 Percent change: -59 NS

H.04.02 Erythromycin (stearate) Erythromycin (base)

24 Papules (count)

Count location: Face. 

Short (2) Raw count: 13 (7.21) .001 Raw count: 21 (9.6)

Parallel Mod

È N=40 .001 0.01

H.04.03 Erythromycin + placebo Tetracycline + placebo

125 Closed comedones change (%) Short (4) Percent change: -7 Percent change: -24

Parallel Mild/mod

È N=178 0.05

Papules change (%) Short (4) Percent change: -39 Percent change: -34 NS

Pustules change (%) Short (4) Percent change: -57 Percent change: -50 NS

Closed comedones change (%) Mid (12) Percent change: -17 Percent change: -36 NS

Open comedones change (%) Mid (12) Percent change: -26 Percent change: -31 NS

Papules change (%) Mid (12) Percent change: -60 Percent change: -62 NS

Pustules change (%) Mid (12) Percent change: -73 Percent change: -65 NS

H.04.03 Erythromycin acistrate Tetracycline

36 Back severity (harcup/median)

Count location: Back. 

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

Parallel Mod/sev

È N=60 .05 NS

Chest severity (harcup/median)

Count location: Chest. 

Mid (12) Measure: 2 .05 Measure: 1 .05 NS

Face/neck severity (harcup/median)

Count location: Face/neck. 

Mid (12) Measure: 2 Measure: 1 .05

Back severity (harcup/median)

Count location: Back. 

Long (24 Measure: 2 .05 Measure: 2 .05 NS

Chest severity (harcup/median)

Count location: Chest. 

Long (24 Measure: 1 .05 Measure: 1 .05 NS

Face/neck severity (harcup/median)

Count location: Face/neck. 

Long (24 Measure: 1 .05 Measure: 1 .05 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 H CONTINUOUS: Page 4 of 15

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

H.05.01 Minocycline Placebo

161 Severity (witkowski) Short (5) Measure: -40 .05 Measure: -16

Cross-over 

È N=43 NS

Severity change [phase ii] (group %) Short (5) Measure: -43 .05 Measure: -24 NS

H.05.02 Minocycline Clindamycin

268 Inflammatory (count)

Count location: Face + or - other. Baseline 

counts: 80 (Target) / 80 (Comparator)

Short (4) Percent Change*: -23 Percent Change*: -30

Parallel Mod/sev

È N=80 NS*

Non-inflammatory (count)

Count location: Face + or - other. Baseline 

counts: 62 (Target) / 60 (Comparator)

Short (4) Percent Change*: -27 Percent Change*: -25 NS*

Overall assessment (vas)

Count location: Face + or - other. 

Short (4) Measure: 27 (20.) Measure: 29 (20.) NS

Inflammatory (count)

Count location: Face + or - other. Baseline 

counts: 80 (Target) / 80 (Comparator)

Mid (12) Percent Change*: -44 .0001 Percent Change*: -31 .0001 NS

Non-inflammatory (count)

Count location: Face + or - other. Baseline 

counts: 62 (Target) / 60 (Comparator)

Mid (12) Percent Change*: -40 .0002 Percent Change*: -33 .0002 NS

Overall assessment (vas)

Count location: Face + or - other. 

Mid (12) Measure: 15 (10.) .0001 Measure: 18 (20.) .0001 NS

Minocycline + placebo Clindamycin phosphate + 

placebo

H.05.02

307 Inflammatory (count) Short (4) Raw count: 38 (5.) Raw count: 35 (5.)

Parallel Mod/sev

È N=64 #Error

Non-inflammatory (count)

Count location: Face. 

Short (4) Raw count: 51 (4.1) NS Raw count: 46 (4.) NS NS

Severity (leeds) Short (4) Measure: 1 (0.6) Measure: 1 (0.5) NS

H.05.04 Minocycline Tetracycline

171 Severity reduction (cumulative %) Short (6) Measure: 52 Measure: 28

Cross-over Mod/sev

N=104 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 H CONTINUOUS: Page 5 of 15

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

298 Severity/investigator (samuelson) Short (6) Measure: 4 (2.3) Measure: 4 (1.66)

Parallel Mod/sev

È N=62 NS

Severity/patient (samuleson) Short (6) Measure: 4 (2.2) Measure: 4 (1.55) NS

171 Severity reduction (cumulative %) Mid (12) Measure: 75 Measure: 70

Cross-over Mod/sev

N=104 NS

298 Severity/investigator (samuelson) Mid (12) Measure: 3 (1.99) Measure: 3 (2.2)

Parallel Mod/sev

È N=62 NS

Severity/patient (samuelson) Mid (12) Measure: 3 (1.9) Measure: 3 (1.98) NS

72 Comedones (count)

Count location: Right. Baseline counts: 35 

(Target) / 30 (Comparator)

N=100 Long (19 Percent Change*: -42 Percent Change*: -36

Cysts (count)

Count location: Right. Baseline counts: 1 

(Target) / 1 (Comparator)

Long (19 Percent Change*: -62 Percent Change*: -57

Papules (count)

Count location: Right. Baseline counts: 16 

(Target) / 11 (Comparator)

Long (19 Percent Change*: -48 Percent Change*: -41

Pustules (count)

Count location: Right. Baseline counts: 9 

(Target) / 14 (Comparator)

Long (19 Percent Change*: -60 Percent Change*: -72

171 Severity reduction (cumulative %) Long (24 Measure: 100 Measure: 100

Cross-over Mod/sev

N=104 NS

Time to severity reduction (days) Long (24 Measure: 63 Measure: 78 NS

Oxytetracycline (oral) + vehicle Benzoyl peroxide + placebo 

(oral)

H.06.02

255 Back severity (leeds)

Count location: Back. 

Mid (12) Measure: 0 (0.19) .02 Measure: 0 (0.41)

Parallel Mod

N=69 NS NS

Chest severity (leeds)

Count location: Chest. 

Mid (12) Measure: 0 (0.13) NS Measure: 0 (0.4) NS NS

Face severity (leeds)

Count location: Face. 

Mid (12) Measure: 0 .001 Measure: 1 .001 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 H CONTINUOUS: Page 6 of 15

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

255 Inflammatory (count)

Baseline counts: 62 (Target) / 57 

(Comparator)

Mid (12) Percent Change*: -23 NS Percent Change*: -42

Parallel Mod

N=69 .001 NS

Non-inflammatory (count)

Count location: Face. 

Mid (12) Raw count: 61 .02 Raw count: 31 .001 NS

Oxytetracycline (oral) + vehicle Tetracycline (topical) + placebo 

(oral)

H.06.05

255 Back severity (leeds)

Count location: Back. 

Mid (12) Measure: 0 (0.19) .02 Measure: 0 (0.47)

Parallel Mod

N=69 NS NS

Chest severity (leeds)

Count location: Chest. 

Mid (12) Measure: 0 (0.13) NS Measure: 0 (0.26) NS NS

Face severity (leeds)

Count location: Face. 

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

Inflammatory (count)

Baseline counts: 62 (Target) / 65 

(Comparator)

Mid (12) Percent Change*: -23 NS Percent Change*: -35 .02 NS

Non-inflammatory (count)

Count location: Face. 

Mid (12) Raw count: 61 .02 Raw count: 43 .003 NS

Oxytetracycline Trimethoprim + 

sulfamethoxazole

H.06.06

152 Severity (leeds)

Count location: Entire face chest & back. 

Mid (12) Measure: 4 (2.6) Measure: 3 (3.3)

Parallel Mild/mod/sev

È N=16 NS

H.06.07 Oxytetracycline Trimethoprim

128 Active papules (sqrt count)

Count location: Face(unspecified). 

Short (4) Percent Change*: -38 .01 Percent Change*: -46

Parallel Mild

È N=45 .01 NS

Active pustules (sqrt count)

Count location: Face (unspecified. 

Short (4) Percent Change*: -49 .01 Percent Change*: -15 .01 NS

Back severity (log leeds)

Count location: Back. 

Short (4) Measure: 0 (0.08) .01 Measure: 0 (0.08) .01 NS

Chest severity (log leeds)

Count location: Chest. 

Short (4) Measure: 0 (0.08) .01 Measure: 0 (0.08) .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 H CONTINUOUS: Page 7 of 15

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

128 Face severity (log leeds)

Count location: Face(unspecified). 

Short (4) Measure: 0 (0.08) .01 Measure: 0 (0.08)

Parallel Mild

È N=45 .01 NS

Less active papules (sqrt count) Short (4) Percent Change*: -26 .01 Percent Change*: -13 .01 NS

Less active pustules (sqrt count)

Count location: Face (unspecified. 

Short (4) Percent Change*: -30 .01 Percent Change*: -35 .01 NS

Active papules (sqrt count)

Count location: Face(unspecified). 

Mid (8) Percent Change*: -47 .01 Percent Change*: -61 .01 NS

Active pustules (sqrt count) Mid (8) Percent Change*: -72 .01 Percent Change*: -63 .01 NS

Back severity (log leeds)

Count location: Back. 

Mid (8) Measure: 0 (0.08) .01 Measure: 0 (0.08) .01 NS

Chest severity (log leeds)

Count location: Chest. 

Mid (8) Measure: 0 (0.08) .01 Measure: 0 (0.08) .01 NS

Face severity (log leeds)

Count location: Face(unspecified). 

Mid (8) Measure: 0 (0.08) .01 Measure: 0 (0.08) .01 NS

Less active papules (sqrt count) Mid (8) Percent Change*: -36 .01 Percent Change*: -27 .01 NS

Less active pustules (sqrt count)

Count location: Face (unspecified. 

Mid (8) Percent Change*: -26 .01 Percent Change*: -24 .01 NS

Trimethoprim + 

sulpamethoxazole

H.07.01 Vehicle

160 Severity change (witkowski %) [phase 1] Short (5) Measure: -62 .001 Measure: -9

Cross-over 

È N=42 NS

Severity change [phase 2] (witkowski %) Short (5) Measure: -43 .001 Measure: 35 NS

Placebo (topical) + tetracycline 

hydrochloride (or

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

23 Severity change (cook)

Count location: Entire face-(photos). 

Short (6) Measure: -1 (1.1) Measure: 0 (1.)

Parallel Mod

È N=75 0.05

Severity change (cook)) Long (13 Measure: -2 (1.2) Measure: -1 (1.2) 0.05

H.08.01 Tetracycline Placebo

201 Severity change (pillsbury modified) Short (6) Measure: -1 (0.3) Measure: 0 (0.3)

Parallel 

È N=51 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 H CONTINUOUS: Page 8 of 15

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

201 Severity change (pillsbury modified) Mid (12) Measure: -2 (0.3) Measure: 0 (0.3)

Parallel 

È N=51 0.001

Tetracycline (oral) + vehicle 

(topical)

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

10 Severity (anderson)

Count location: Butterfly. 

Short (6) Measure: 4 NS Measure: 4

Parallel Mod

N=60 NS NS

H.08.01 Tetracycline + Placebo Placebo

136 Papules (count)

Count location: Face above jawline. Between 

P-value: T > P.Baseline counts: 22 (Target) / 

11 (Comparator)

Short (6) Percent Change*: -59 Percent Change*: 24

Parallel Mod/sev

N=305 0.05

Pustules (count)

Count location: Face above jawline. Baseline 

counts: 5 (Target) / 4 (Comparator)

Short (6) Percent Change*: -60 Percent Change*: -40 NS

Papules (count)

Count location: Face above jawline. Between 

P-value: T > P.Baseline counts: 22 (Target) / 

11 (Comparator)

Mid (8) Percent Change*: -63 Percent Change*: 07 0.05

Pustules (count)

Count location: Face above jawline. Between 

P-value: T > P.Baseline counts: 5 (Target) / 4 

(Comparator)

Mid (8) Percent Change*: -68 Percent Change*: -37 0.05

H.08.01 Tetracycline + vehicle Vehicle (oral) + vehicle (topical)

33 Inflammatory (count)

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

Short (6) Percent Change*: -51 .0001 Percent Change*: -12

Parallel Mild

N=87 NS*

Inflammatory (count)

Between P-value: compared to clinda.Baseline 

counts: 6 (Target) / 7 (Comparator)

Mid (8) Percent Change*: -57 .0001 Percent Change*: -12 NS 0.0004

Tetracycline hydrochloride 

(oral) + placebo

H.08.01 Placebo + placebo

313 Severity (cook)

Count location: Face. Between P-value: with 

respect to topical.

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

Parallel Mild/mod

È N=149 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 H CONTINUOUS: Page 9 of 15

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

313 Severity (cook)

Count location: Face. Between P-value: with 

respect to topical.

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

Parallel Mild/mod

È N=149 NS NS

Tetracycline (oral) + Placebo 

(lotion)

Clindamycin (lotion) + Placebo 

(oral)

H.08.02

318 Overall change/patient (stoughton) Short (6) Measure: 2 Measure: 2

Parallel Mod

N=50 0.014

Papules (count)

Count location: Face unspecified. Baseline 

counts: 18 (Target) / 17 (Comparator)

Short (6) Percent Change*: -36 Percent Change*: -67 0.01

H.08.02 Tetracycline + Placebo Clindamycin + Placebo

136 Papules (count)

Count location: Face above jawline. Between 

P-value: T > P.Baseline counts: 22 (Target) / 

23 (Comparator)

Short (6) Percent Change*: -59 Percent Change*: -62

Parallel Mod/sev

N=305 0.05

Pustules (count)

Count location: Face above jawline. Baseline 

counts: 5 (Target) / 5 (Comparator)

Short (6) Percent Change*: -60 Percent Change*: -67 NS

Papules (count)

Count location: Face above jawline. Between 

P-value: T > P.Baseline counts: 22 (Target) / 

23 (Comparator)

Mid (8) Percent Change*: -63 Percent Change*: -68 0.05

Pustules (count)

Count location: Face above jawline. Between 

P-value: T > P.Baseline counts: 5 (Target) / 5 

(Comparator)

Mid (8) Percent Change*: -68 Percent Change*: -76 0.05

H.08.02 Tetracycline + vehicle Clindamycin + vehicle

33 Inflammatory (count)

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

Short (6) Percent Change*: -51 .0001 Percent Change*: -68

Parallel Mild

N=87 .0001 NS*

Inflammatory (count)

Between P-value: compared to clinda.Baseline 

counts: 6 (Target) / 9 (Comparator)

Mid (8) Percent Change*: -57 .0001 Percent Change*: -72 .0001 0.0004

 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 H CONTINUOUS: Page 10 of 15

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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

Tetracycline + vehicle Clindamycin phosphate + 

placebo

H.08.02

29 Nodules (count)

Count location: Entire face. Baseline counts: 1 

(Target) / 1 (Comparator)

Short (4) Percent Change*: -22 Percent Change*: -58

Parallel Mod

È N=20 NS*

Papules (count)

Count location: Entire face. Baseline counts: 

27 (Target) / 21 (Comparator)

Short (4) Percent Change*: -51 Percent Change*: -39 NS*

Pustules (count)

Count location: Entire face. Baseline counts: 7 

(Target) / 5 (Comparator)

Short (4) Percent Change*: -66 Percent Change*: -22 NS*

Nodules (count)

Count location: Entire face. Baseline counts: 1 

(Target) / 1 (Comparator)

Mid (8) Percent Change*: -78 Percent Change*: -67 NS*

Papules (count)

Count location: Entire face. Baseline counts: 

27 (Target) / 21 (Comparator)

Mid (8) Percent Change*: -76 Percent Change*: -70 NS*

Pustules (count)

Count location: Entire face. Baseline counts: 7 

(Target) / 5 (Comparator)

Mid (8) Percent Change*: -69 Percent Change*: -70 NS*

Tetracycline hydrochloride + 

placebo

H.08.02 Clindamycin + placebo

186 Closed comedones (count) Short (6) Raw count: 4 (4.) Raw count: 6 (14.)

Parallel Mod

Í N=44 NS*

Nodules (count) Short (6) Raw count: 1 (0.3) Raw count: 1 (2.) NS*

Open comedones (count) Short (6) Raw count: 5 (4.) Raw count: 7 (18.) NS*

Papules (count) Short (6) Raw count: 6 (4.) Raw count: 7 (9.) NS*

Pustules (count) Short (6) Raw count: 6 (4.) Raw count: 7 (8.) NS*

Closed comedones (count) Mid (12) Raw count: 3 (4.) Raw count: 3 (8.) NS*

Nodules (count) Mid (12) Raw count: 0 (0.2) Raw count: 1 (0.8) NS*

Open comedones (count) Mid (12) Raw count: 4 (4.) Raw count: 4 (8.) NS*

Pustules (count) Mid (12) Raw count: 4 (4.) Raw count: 2 (4.) 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 H CONTINUOUS: Page 11 of 15

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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

Tetracycline hydrochloride + 

placebo (topical)

H.08.03 Erythromycin + placebo (oral)

279 Closed comedones change (count)

Baseline counts: 26 (Target) / 22 

(Comparator)

Short (4) Percent change*: -16 NS Percent change*: -31

Parallel Mod/sev

È N=54 .05 NS

Comedones change (count)

Baseline counts: 26 (Target) / 26 

(Comparator)

Short (4) Percent change*: -29 NS Percent change*: -34 .01 NS

Inflammatory change (count)

Baseline counts: 30 (Target) / 32 

(Comparator)

Short (4) Percent change*: -59 .001 Percent change*: -66 .001 NS*

Open comedone change (count)

Baseline counts: 13 (Target) / 5 (Comparator)

Short (4) Percent change*: -27 NS Percent change*: -47 NS NS

Papules change (count)

Baseline counts: 24 (Target) / 26 

(Comparator)

Short (4) Percent change*: -57 .001 Percent change*: -66 .001 NS*

Pustules change (count)

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

Short (4) Percent change*: -66 .01 Percent change*: -62 .001 NS*

Closed comedone change (count)

Baseline counts: 26 (Target) / 22 

(Comparator)

Mid (12) Percent change*: -31 .05 Percent change*: -48 .001 NS

Comedones change (count)

Baseline counts: 26 (Target) / 26 

(Comparator)

Mid (12) Percent change*: -58 .05 Percent change*: -51 .001 NS

Inflammatory change (count)

Baseline counts: 30 (Target) / 32 

(Comparator)

Mid (12) Percent change*: -45 .001 Percent change*: -65 .001 NS*

Open comedone change (count)

Baseline counts: 13 (Target) / 5 (Comparator)

Mid (12) Percent change*: -56 NS Percent change*: -67 .01 NS

Papules change (count)

Baseline counts: 24 (Target) / 26 

(Comparator)

Mid (12) Percent change*: -42 .001 Percent change*: -63 .001 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 H CONTINUOUS: Page 12 of 15

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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

279 Pustules change (count)

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

Mid (12) Percent change*: -55 .01 Percent change*: -70

Parallel Mod/sev

È N=54 .01 NS*

Placebo (topical) + tetracycline 

hydrochloride (or

Tetracycline hydrochloride 

(topical) + placebo (or

H.08.04

23 Severity change (cook)

Count location: Entire face-(photos). 

Short (6) Measure: -1 (1.1) Measure: -1 (0.85)

Parallel Mod

È N=75 0.05

Severity change (cook)) Long (13 Measure: -2 (1.2) Measure: -1 (1.4) 0.05

Tetracycline (oral) + vehicle 

(topical)

Tetracycline (topical) + placebo 

(oral)

H.08.04

10 Severity (anderson)

Count location: Butterfly. 

Short (6) Measure: 4 NS Measure: 3

Parallel Mod

N=60 NS NS

Tetracycline hydrochloride 

(oral) + placebo

Tetracycline hydrochloride 

(topical) + placebo

H.08.04

313 Severity (cook)

Count location: Face. Between P-value: with 

respect to topical.

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

Parallel Mild/mod

È N=149 .05 NS

Severity (cook) Mid (12) Measure: 2 .05 Measure: 2 .05 NS

H.08.05 Tetracycline + placebo Azelaic acid + placebo

22 Face severity (leeds) Short (4) Measure: 1 Measure: 2

Parallel Mod/sev

Í N=45 NS

Non-inflammatory (count) Short (4) Raw count: 41 Raw count: 44 NS

Total inflammatory (count)

Baseline counts: 43 (Target) / 44 

(Comparator)

Short (4) Percent Change*: -35 Percent Change*: -14 NS

Total lesions (count)

Baseline counts: 130 (Target) / 128 

(Comparator)

Short (4) Percent Change*: -28 Percent Change*: -16 NS

Total severity (leeds) Short (4) Measure: 2 Measure: 4 NS

Face severity (leeds) Mid (8) Measure: 1 NS Measure: 1 NS NS

Non-inflammatory (count/median) Mid (8) Measure: 30 sig Measure: 42 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 H CONTINUOUS: Page 13 of 15

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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

22 Total inflammatory (count)

Baseline counts: 43 (Target) / 44 

(Comparator)

Mid (8) Percent Change*: -49 sig Percent Change*: -32

Parallel Mod/sev

Í N=45 sig NS

Total lesions (count/median) Mid (8) Measure: 90 Measure: 88 NS

Total severity (leeds) Mid (8) Measure: 1 sig Measure: 4 NS NS

Face severity (leeds) Long (24 Measure: 0 Measure: 1 NS

Inflammatory (count) Long (24 Raw count: 12 Raw count: 28 NS

Non-inflammatory (count) Long (24 Raw count: 22 Raw count: 28 NS

Total lesions (count)

Baseline counts: 130 (Target) / 128 

(Comparator)

Long (24 Percent Change*: -54 Percent Change*: -41 0.05

Total severity (leeds) Long (24 Measure: 1 .001 Measure: 2 .01 0.05

H.08.05 Tetracycline hydrochloride Azelaic acid + placebo

166 Total lesions (count/median) Long (20 Measure: 5 sig Measure: 6

Parallel Mild/mod

È N=333 sig NS

Tetracycline hydrochloride + 

placebo

H.08.05 Azelaic acid + placebo

167 Nodes+cysts (count/median)

Count location: Half face. 

Mid (12) Measure: 5 Measure: 6

Parallel Mod/sev

È N=261 NS

Inflammatory (count/median) Long (24 Measure: 3 Measure: 2 NS

Nodes+cysts (count/median) Long (24 Measure: 3 Measure: 2 NS

Tetracycline + vehicle Meclocycline sulfosalicylate + 

placebo

H.08.06

164 Closed comedones change (%) Short (4) Percent change: -70 Percent change: -36

Parallel Mild/mod

È N=60 NS

Cysts change (%) Short (4) Percent change: -80 Percent change: -76 NS

Open comedones change (%) Short (4) Percent change: -29 Percent change: 62 0.02

Papules change (%) Short (4) Percent change: -64 Percent change: -28 NS

Pustules change (%) Short (4) Percent change: -57 Percent change: -41 NS

Total lesions change (%) Short (4) Percent change: -67 Percent change: -49 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 H CONTINUOUS: Page 14 of 15

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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

164 Closed comedones change (%) Mid (8) Percent change: -83 Percent change: -60

Parallel Mild/mod

È N=60 NS

Cysts change (%) Mid (8) Percent change: -85 Percent change: -92 NS

Open comedones change (%) Mid (8) Percent change: -74 Percent change: 21 0.04

Papules change (%) Mid (8) Percent change: -63 Percent change: -77 NS

Pustules change (%) Mid (8) Percent change: -80 Percent change: -63 NS

Total lesions change (%) Mid (8) Percent change: -77 Percent change: -76 NS

H.09.02 Phenethicillin Placebo

312 Overall change/patient (score) Short (4) Measure: 3 (4.8) Measure: 3 (4.8)

Parallel Mild/mod/sev

È N=66 NS

Severity change/photo (score)

Count location: Entire face. 

Short (4) Measure: 1 (3.1) Measure: 1 (2.4) 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 H CONTINUOUS: Page 15 of 15

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