Evidence Table M2. CONTINUOUS outcomes for class ANTI-ANDROGEN.

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

M.01.01 Cyproterone (topical) Vehicle

141 Face severity (leeds) Mid (8) Measure: 1 (0.02) Measure: 1 (0.08)

Parallel Mild/mod

Í N=45 NS*

Face severity change (leeds) Mid (12) Measure: -1 (0.11) Measure: 0 (0.04) 0.05

Total lesions (count)

Count location: Excluded nose. Baseline 

counts: 36 (Target) / 38 (Comparator)

Mid (12) Percent Change*: -51 Percent Change*: -28 NS*

Total lesions change (count) Mid (12) Percent change*: -75 Percent change*: -40 0.05

M.01.02 Cyproterone + ethinyl estradiol Minocycline hydrochloride

245 Comedones (count/median) Mid (8) Measure: 8 Measure: 10

Parallel Mild/mod

Í N=98

Papules (count/median) Mid (8) Measure: 16 Measure: 14

Pustules (count/median) Mid (8) Measure: 8 Measure: 7

Comedones (count/max range) Long (24 Measure: 63 .01 Measure: 327 .01

Comedones (count/median) Long (24 Measure: 5 .01 Measure: 4 .01

Papules (count/max) Long (24 Measure: 6 .01 Measure: 7 .01

Papules range (count/max) Long (24 Measure: 81 Measure: 307

Pustules (count/max) Long (24 Measure: 48 Measure: 189

Pustules (count/median) Long (24 Measure: 2 .01 Measure: 2 .01

Cyproterone + ethinyl estradiol 

+ placebo

M.01.03 Tetracycline + placebo

137 Face severity change (leeds %) Short (6) Measure: -29 .001 Measure: -25

Parallel 

È N=92 .001

Inflammatory change (%) Mid (8) Percent change: -20 .05 Percent change: -9 .05

Non-inflammatory change (%) Mid (8) Percent change: -37 .01 Percent change: -18 .05

Total severity change (leeds %) Mid (8) Measure: -20 .01 Measure: -22 .05

Face severity change (leeds %) Long (24 Measure: -71 .001 Measure: -72 .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 M CONTINUOUS: Page 1 of 7

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

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

Target Between

 P-value

Comparison

137 Inflammatory change (%)

Between P-value: vs tetracucline alone or 

combined.

Long (24 Percent change: -72 .001 Percent change: -50

Parallel 

È N=92 .001 NS

Non-inflammatory change (%) Long (24 Percent change: -76 NS Percent change: -63 .05

Total severity change (leeds %)

Between P-value: vs tetracucline alone or 

combined.

Long (24 Measure: -75 .001 Measure: -68 .001 NS

Post-therapy facial severity change (leeds 

%)

Long (32 Measure: -72 .001 Measure: -55 .01

Post-therapy inflammatory change (%)

Between P-value: vs cyp/ee + tet.

Long (32 Percent change: -79 .001 Percent change: -60 .05 NS

Post-therapy non-inflammatory change (%) Long (32 Percent change: -81 .01 Percent change: -66 .05

Post-therapy total severity change (leeds %) Long (32 Measure: -75 .001 Measure: -55 NS

Cyproterone + ethinyl estradiol 

(0.035)

M.01.04 Cyproterone (topical)

141 Face severity (leeds) Mid (8) Measure: 1 (0.02) Measure: 1 (0.02)

Parallel Mild/mod

Í N=45 NS*

Total lesions (count)

Baseline counts: 45 (Target) / 36 

(Comparator)

Mid (8) Percent Change*: -45 Percent Change*: -51 NS*

Face severity change (leeds) Mid (12) Measure: -1 (0.12) Measure: -1 (0.11) 0.05

Total lesions change (count)

Count location: Excluded nose. Baseline 

counts: 45 (Target) / 36 (Comparator)

Mid (12) Percent change*: -66 Percent change*: -75 0.05

Cyproterone + ethinyl estradiol 

(0.05)

Cyproterone + ethinyl estradiol 

(0.035)

M.01.05

48 Total lesions change (%)

Between P-value: vs Levonogestrel.

Long (16 Percent change: -51 (52.) Percent change: -61 

Parallel (31.)

È N=133 0.05

117 Comedones severity (cook)

Count location: Face. 

Long (24 Measure: 1 .01 Measure: 2

Parallel Mod/sev

Í N=73 .01 NS

Macules score (cook) Long (24 Measure: 2 .01 Measure: 2 .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 M CONTINUOUS: Page 2 of 7

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

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

Target Between

 P-value

Comparison

117 Papules score (cook)

Count location: Face. 

Long (24 Measure: 2 .01 Measure: 2

Parallel Mod/sev

Í N=73 .01 NS

Severity (cook) Long (24 Measure: 2 .01 Measure: 2 .01 NS

48 Total lesions change (%)

Between P-value: vs Levonogestrel.

Long (24 Percent change: -70 (36.) Percent change: -72 

Parallel (27.)

È N=133 0.001

66 N=96 Severity change/patient (vas) Long (36 Measure: 5 (2.7) .001 Measure: 5 (2.4) .001 NS

117 Comedones severity (cook)

Count location: Face. 

Long (48 Measure: 1 .01 Measure: 1

Parallel Mod/sev

Í N=73 .01 NS

Macules score (cook) Long (48 Measure: 1 .01 Measure: 1 .01 NS

Papules time (cook) Long (48 Measure: 1 .01 Measure: 1 .01 NS

Severity (cook) Long (48 Measure: 1 .01 Measure: 1 .01 NS

Cyproterone + ethinyl estradiol 

(0.05)

Levonorgestrel + ethinyl 

estradiol (0.030)

M.01.05

48 Total lesions change (%)

Between P-value: vs Levonogestrel.

Long (16 Percent change: -51 (52.) Percent change: -27 

Parallel (52.)

È N=133 0.05

Total lesions change (%) Long (24 Percent change: -70 (36.) Percent change: -35 

(60.)

0.001

Cyproterone (2 mg) + ethinyl 

estradiol

Cyproterone (.05 mg) + ethinyl 

estradiol

M.01.06

237 Face severity (leeds) Mid (8) Measure: 1 .01 Measure: 1

Parallel Mod/sev

N=90 .001

Face severity/photo

Between P-value: vs norethisterone.

Mid (8) Measure: 1 Measure: 1 NS

Macules (count) Mid (8) Raw count: 75 (66.) Percent Change*: 35 NS

Papules (count) Mid (8) Raw count: 27 (37.) NS Percent Change*: -15 NS NS

Total severity (leeds)

Between P-value: vs norethisterone.

Mid (8) Measure: 2 .05 Measure: 2 .05 0.05

Face severity (leeds) Long (26 Measure: 1 .001 Measure: 0 .001 0.001

Face severity/photo Long (26 Measure: 1 Measure: 0 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 M CONTINUOUS: Page 3 of 7

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

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

Target Between

 P-value

Comparison

237 Nodules (count)

Between P-value: "worse than cyproterone 

(50) " P.05.

Long (26 Raw count: 39 (64.) Raw count: 21 (45.)

Parallel Mod/sev

N=90 NS*

Papules (count) Long (26 Raw count: 15 (18.) .005 Percent Change*: -79 .001 NS*

Total severity (leeds)

Between P-value: vs norethisterone.

Long (26 Measure: 1 .001 Measure: 1 .001 0.05

Cyproterone + ethinyl estradiol 

(0.035)

M.01.07 Desogestrel + ethinyl estradiol

87 Comedones change (count/median) Long (16 Measure: -6 Measure: -3

Parallel Mild

Í N=183

Papules change (count/median) Long (16 Measure: -5 Measure: -5

Pustules change (count/median) Long (16 Measure: -3 Measure: -2

Severity (leeds) Long (16 Measure: 1 (0.53) Measure: 0 (0.42) NS*

Severity change (dieben/median) Long (16 Measure: 0 (0.53) Measure: 0 (0.45) NS*

Desogestrel + ethinyl estradiol Cyproterone + ethinyl estradiol 

(.05)

M.01.07

55 Severity [center a] (charoenvisal)

Count location: Face. 

Short (4) Measure: 2 NS Measure: 2

Parallel 

Í N=66 NS NS

Severity [center b] (charoenvisal) Short (4) Measure: 2 NS Measure: 2 NS NS

Severity [center a] (charoenvisal) Mid (12) Measure: 1 NS Measure: 1 .05 NS

Severity [center b] (charoenvisal) Mid (12) Measure: 2 .05 Measure: 2 NS NS

Severity [center a] (charoenvisal) Long (24 Measure: 2 NS Measure: 1 .05 0.05

Severity [center b] (charoenvisal) Long (24 Measure: 1 .01 Measure: 1 .001 NS

Cyproterone + ethinyl estradiol 

(0.035)

Levonorgestrel + ethinyl 

estradiol (0.030)

M.01.08

48 Total lesions change (%) Long (16 Percent change: -61 (31.) Percent change: -27 

Parallel (52.)

È N=133 NS

Total lesions change (%)

Between P-value: vs Levonogestrel.

Long (24 Percent change: -72 (27.) Percent change: -35 

(60.)

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 M CONTINUOUS: Page 4 of 7

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

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

Target Between

 P-value

Comparison

Cyproterone (.05 mg) + ethinyl 

estradiol

Norethisterone + placebo + 

ethinyl estradiol

M.01.09

237 Face severity (leeds)

Between P-value: vs norethisterone.

Mid (8) Measure: 1 .001 Measure: 1

Parallel Mod/sev

N=90 .001 0.05

Face severity/photo Mid (8) Measure: 1 Measure: 1 0.05

Macules (count)

Baseline counts: 43 (Target) / (Comparator)

Mid (8) Percent Change*: 35 Raw count: 56 (64.) NS

Papules (count)

Baseline counts: 27 (Target) / 30 

(Comparator)

Mid (8) Percent Change*: -15 NS Percent Change*: -10 NS NS

Total severity (leeds)

Between P-value: vs norethisterone.

Mid (8) Measure: 2 .05 Measure: 3 NS 0.01

Face severity (leeds) Long (26 Measure: 0 .001 Measure: 1 .001 0.001

Face severity/photo Long (26 Measure: 0 Measure: 1 0.001

Nodules (count) Long (26 Raw count: 21 (45.) Percent Change*: 26 NS*

Papules (count)

Baseline counts: 27 (Target) / 30 

(Comparator)

Long (26 Percent Change*: -79 .001 Percent Change*: -34 NS NS*

Total severity (leeds)

Between P-value: vs norethisterone.

Long (26 Measure: 1 .001 Measure: 2 .05 0.01

M.02.01 Desogestrel + ethinyl estradiol Gestodene + ethinyl estradiol

225 Severity/arm (pillsbury)

Count location: Each side of face. 

Mid (12) Measure: 2 Measure: 2

Parallel Mild/mod

Í N=24

Severity/arm (pillsbury) Long (36 Measure: 1 .05 Measure: 1 .02

Desogestrel + ethinyl estradiol Levonorgestrel + ethinyl 

estradiol

M.02.02

264 Severity (allen-smith) Long (24 Measure: 1 (0.55) .001 Measure: 1 (0.56)

Parallel Mild/mod

È N=33 .01 0.05

M.03.01 Spironolactone Placebo

 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 M CONTINUOUS: Page 5 of 7

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

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

Target Between

 P-value

Comparison

249 Total lesions [phase i+phase ii] (count)

Baseline counts: 38 (Target) / 24 

(Comparator)

Mid (12) Percent Change*: -66 Percent Change*: 05

Cross-over Mild/mod

È N=58 0.001

M.04.06 Inocoterone acetate Vehicle

213 Comedones (count)

Baseline counts: 22 (Target) / 26 

(Comparator)

Short (4) Percent Change*: 05 Percent Change*: -19

Parallel Mod

È N=153 NS

Inflammatory (count)

Baseline counts: 26 (Target) / 27 

(Comparator)

Short (4) Percent Change*: -15 Percent Change*: -11 NS

Comedones (count)

Baseline counts: 22 (Target) / 26 

(Comparator)

Mid (12) Percent Change*: -09 Percent Change*: -12 NS

Inflammatory (count)

Baseline counts: 26 (Target) / 27 

(Comparator)

Mid (12) Percent Change*: -23 Percent Change*: -15 0.019

Comedones (count)

Baseline counts: 22 (Target) / 26 

(Comparator)

Long (16 Percent Change*: -09 Percent Change*: -19 NS

Inflammatory (count)

Baseline counts: 26 (Target) / 27 

(Comparator)

Long (16 Percent Change*: -31 Percent Change*: -15 0.025

Norgestimate + ethinyl estradiol 

+ inactive drug

M.04.09 Placebo

218 Total lesions change (%) Mid (12) Percent change: -33 Percent change: -22

Parallel Mod

È N=257 NS

Total lesions change (%) Long (24 Percent change: -53 

(29.9)

Percent change: -27 

(43.7)

0.0001

280 Comedones change (count)

Count location: Face. Baseline counts: 37 

(Target) / 38 (Comparator)

È N=250 Long (26 Percent change*: 40 Percent change*: 34 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 M CONTINUOUS: Page 6 of 7

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Trial # 

Method 

Continuous Outcome Name (Units)

Definition/Comments

Followup (wks)Comparator

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

Target Between

 P-value

Comparison

218 Comedones change (count)

Baseline counts: 35 (Target) / 30 

(Comparator)

Long (26 Percent change*: 49 Percent change*: 22

Parallel Mod

È N=257 0.0003

Inflammatory (count)

Baseline counts: 19 (Target) / 20 

(Comparator)

Long (26 Percent Change*: -39 Percent Change*: -62 0.0001

280 Inflammatory change (count)

Baseline counts: 19 (Target) / 19 

(Comparator)

È N=250 Long (26 Percent change*: 49 Percent change*: 35 0.02

218 Nodules change (count)

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

È N=257 Long (26 Percent change*: 33 Percent change*: 00 NS

280 Total lesions change (count)

Count location: Face. Baseline counts: 56 

(Target) / 57 (Comparator)

È N=250 Long (26 Percent change*: 43 Percent change*: 34 NS

M.04.10 Quinestradol Placebo

248 Comedones (count)

Count location: Left side. Baseline counts: 32 

(Target) / 28 (Comparator)

Mid (8) Percent Change*: -50 .01 Percent Change*: -29

Parallel Mild/mod

Í N=60 NS NS*

Total lesions (count)

Count location: Left side. 

Mid (8) Raw count: 22 (15.6) .001 Raw count: 27 (18.3) .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 M CONTINUOUS: Page 7 of 7

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