Evidence Table K2. CONTINUOUS outcomes for class RETINOID (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

K.02.01 Isotretinoin Placebo

269 Cysts change (%) Short (4) Percent change: -17 Percent change: 33

Parallel Sev

È N=33 0.001

K.02.02 Isotretinoin Dapsone

276 Chest/back total lesions (count)

Baseline counts: 38 (Target) / 39 

(Comparator)

Short (4) Percent Change*: -53 NS Percent Change*: -33

Parallel Sev

N=40 NS NS*

Face/neck total lesions (count)

Baseline counts: 25 (Target) / 21 

(Comparator)

Short (4) Percent Change*: -64 Percent Change*: -38 NS*

Overall change/patient vas (p-value) Short (4) Measure: 0 .01 Measure: 1 NS

Total severity/photo (leeds) Short (4) Measure: 5 (3.6) NS Measure: 5 (2.4) NS NS*

Chest/back total lesions (count)

Baseline counts: 38 (Target) / 39 

(Comparator)

Mid (8) Percent Change*: -66 NS Percent Change*: -36 NS NS*

Face/neck total lesions (count)

Baseline counts: 25 (Target) / 21 

(Comparator)

Mid (8) Percent Change*: -76 Percent Change*: -43 NS*

Overall change/patient vas (p value) Mid (8) Measure: 0 .001 Measure: 0 .05

Total severity/photo (leeds) Mid (8) Measure: 5 (3.6) .01 Measure: 6 (4.) NS NS*

Chest/back total lesions (count)

Baseline counts: 38 (Target) / 39 

(Comparator)

Long (16 Percent Change*: -89 .01 Percent Change*: -36 NS NS*

Face/neck total lesions (count)

Baseline counts: 25 (Target) / 21 

(Comparator)

Long (16 Percent Change*: -88 .0001 Percent Change*: -57 .05

Overall change/patient vas (p value) Long (16 Measure: 0 .001 Measure: 0 .01

Total severity/photo (leeds) Long (16 Measure: 5 (4.) .01 Measure: 6 (3.6) 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 K 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

276 Post-therapy chest/back total lesions (count)

Baseline counts: 38 (Target) / 39 

(Comparator)

Long (36 Percent Change*: -89 .01 Percent Change*: -33

Parallel Sev

N=40 NS NS*

Post-therapy face/neck total lesions (count)

Baseline counts: 25 (Target) / 21 

(Comparator)

Long (36 Percent Change*: -92 .0001 Percent Change*: -57 0.01

Post-therapy overall change/patient vas (p 

value

Long (36 Measure: 0 .001 Measure: 1 NS

Post-therapy total severity/photo (leeds) Long (36 Measure: 3 (3.6) .0005 Measure: 7 (3.) .01 NS*

K.02.03 Isotretinoin Tetracycline hydrochloride

206 Comedones+pustules (count)

Baseline counts: 27 (Target) / 18 

(Comparator)

Short (4) Percent Change*: -40 Percent Change*: -49

Parallel Sev

Í N=30 NS*

Cysts (count)

Baseline counts: 21 (Target) / 23 

(Comparator)

Short (4) Percent Change*: -25 Percent Change*: -29 NS*

Cysts diameters (mm) Short (4) Measure: 140 (100.) Measure: 135 (80.) NS*

Comedones+pustules (count)

Baseline counts: 27 (Target) / 18 

(Comparator)

Mid (12) Percent Change*: -66 Percent Change*: -38 NS*

Cysts (count)

Baseline counts: 21 (Target) / 23 

(Comparator)

Mid (12) Percent Change*: -53 Percent Change*: -47 NS*

Cysts diameters (mm) Mid (12) Measure: 90 (70.) Measure: 100 (100.) NS*

Post-therapy long term cyst (count)

Baseline counts: 21 (Target) / 23 

(Comparator)

Long (34. Percent Change*: -85 Percent Change*: -73 0.02

Post-therapy comedones+pustules (count)

Baseline counts: 27 (Target) / 18 

(Comparator)

Long (35 Percent Change*: -94 Percent Change*: -60 0.01

Post-therapy cyst diameters (mm) Long (35 Measure: 31 (57.6) Measure: 57 (66.5) 0.01

K.02.05 Isotretinoin Etretinate

 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 K 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

130 Nodulocystic change (%)

Count location: Face unspecified. 

Short (4) Percent change: -20 Percent change: -5

Parallel Sev

N=56

Nodulocystic change/face (%) Short (4) Percent change: -39 Percent change: -19

Nodulocystic change (%) Mid (8) Percent change: -43 Percent change: -8 0.05

Nodulocystic change/face (%) Mid (8) Percent change: -68 Percent change: -20 0.05

Nodulocystic change post-therapy (%) Long (16 Percent change: -69 Percent change: -33 0.05

Nodulocystic change post-treatment/face 

(%)

Long (16 Percent change: -72 Percent change: -29 0.05

K.02.06 Isotretinoin (0.1) Isotretinoin (1.0)

190 Severity/face (king)

Count location: Face unspecified. 

Short (4) Measure: 2 Measure: 2 (1.5)

Parallel Mild/mod/sev

N=48 NS

106 Cystic change (%)

Count location: Designated area of face, chest 

and/or back. 

Short (6) Percent change: -16 Percent change: -44

Parallel Sev

N=16 NS

Cystic diameter change (%) Short (6) Percent change: -20 Percent change: -63 NS

Cheilitis duration (%) Mid (12) Percent change: 11 Percent change: 12

Cystic change (%)

Count location: Designated area of face, chest 

and/or back. 

Mid (12) Percent change: -49 Percent change: -65 NS

Cystic diameter change (%) Mid (12) Percent change: -57 Percent change: -76 NS

Desquamation duration (week) Mid (12) Measure: 7 Measure: 12

Puritus duration (weeks) Mid (12) Measure: 5 Measure: 8

190 Severity/face (king)

Count location: Face unspecified. 

Mid (12) Measure: 1 (0.4) Measure: 1

Parallel Mild/mod/sev

N=48 NS

Severity/face (king) Long (16 Measure: 0 (0.7) Measure: 1 NS

106 Cystic change post-treatment (%)

Count location: Designated area of face, chest 

and/or back. 

Long (20 Percent change: -56 Percent change: -88

Parallel Sev

N=16 NS

Cystic diameter change post-treatment Long (20 Measure: -67 Measure: -91 NS

K.02.06 Isotretinoin (0.5) Isotretinoin (0.1)

 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 K 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

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Short (4) Percent change: -15 Percent change: -28

Parallel Sev

N=150 NS

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Short (4) Percent change: -20 Percent change: -30 0.01

185 Non-inflammatory change (%) Short (4) Percent change: -39 Percent change: -22 

Parallel Mod (72.4)

È N=76

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Mid (12) Percent change: -67 Percent change: -72

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Between P-value: .05 > 1.0.

Mid (12) Percent change: -48 Percent change: -52 0.05

185 Non-inflammatory change (%) Mid (12) Percent change: -73 

(47.7)

Percent change: -66

Parallel Mod

È N=76

Non-inflammatory change (%) Long (16 Percent change: -83 

(34.1)

Percent change: -80

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Long (20 Percent change: -77 Percent change: -77

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Long (20 Percent change: -68 Percent change: -58 0.01

Inflammatory change post therapy/face (%)

Count location: Face unspecified. 

Long (32 Percent change: -90 Percent change: -90 0.01

Inflammatory change/trunk post-therapy 

Count location: Back or chest unspecified. (%)

Long (32 Percent change: -80 Percent change: -88 0.01

185 Post-therapy non-inflammatory change (%) Long (32 Percent change: -91 Percent change: -89 

Parallel Mod (20.1)

È N=76

K.02.06 Isotretinoin (0.5) Isotretinoin (1.0)

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Short (4) Percent change: -15 Percent change: -32

Parallel Sev

N=150 NS

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Short (4) Percent change: -20 Percent change: -5 0.01

Inflammatory change/face (%)

Count location: Face unspecified. 

Mid (12) Percent change: -67 Percent change: -70 0.01

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

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

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

between Target and Comparator arms.

EvidenceTable K 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

320 Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Between P-value: .05 > 1.0.

Mid (12) Percent change: -48 Percent change: -24

Parallel Sev

N=150 0.05

Inflammatory change/face (%)

Count location: Face unspecified. 

Long (20 Percent change: -77 Percent change: -90 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Long (20 Percent change: -68 Percent change: -56 0.01

Inflammatory change post therapy/face (%)

Count location: Face unspecified. 

Long (32 Percent change: -90 Percent change: -95 0.01

Inflammatory change/trunk post-therapy 

Count location: Back or chest unspecified. (%)

Long (32 Percent change: -80 Percent change: -78 0.01

K.02.06 Isotretinoin (1.0) Isotretinoin (0.1)

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Short (4) Percent change: -32 Percent change: -28

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Short (4) Percent change: -5 Percent change: -30 NS

185 Non-inflammatory change (%) Short (4) Percent change: -48 

(38.7)

Percent change: -22 

Parallel Mod (72.4)

È N=76

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Mid (12) Percent change: -70 Percent change: -72

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Between P-value: 1.0 < 0.5.

Mid (12) Percent change: -24 Percent change: -52 NS

185 Non-inflammatory change (%) Mid (12) Percent change: -81 (35.) Percent change: -66

Parallel Mod

È N=76

Non-inflammatory change (%) Long (16 Percent change: -88 

(15.4)

Percent change: -80

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Long (20 Percent change: -90 Percent change: -77

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Long (20 Percent change: -56 Percent change: -58 0.01

Inflammatory change post therapy/face (%)

Count location: Face unspecified. 

Long (32 Percent change: -95 Percent change: -90 0.01

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

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

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

between Target and Comparator arms.

EvidenceTable K 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

320 Inflammatory change/trunk post-therapy 

Count location: Back or chest unspecified. (%)

Long (32 Percent change: -78 Percent change: -88

Parallel Sev

N=150 0.01

185 Post-therapy non-inflammatory change (%) Long (32 Percent change: -94 

(14.7)

Percent change: -89 

Parallel Mod (20.1)

È N=76

K.02.06 Isotretinoin (1.0) Isotretinoin (0.5)

332 Comedones (median)

Count location: Unspecified. 

Short (4) Measure: 100 Measure: 120

Parallel Mild/mod/sev

N=58

Infiltrates (median) Short (4) Measure: 7 Measure: 5

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Short (4) Percent change: -32 Percent change: -15

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Short (4) Percent change: -5 Percent change: -20 NS

185 Non-inflammatory change (%) Short (4) Percent change: -48 

(38.7)

Percent change: -39

Parallel Mod

È N=76

332 Papules (median)

Count location: Unspecified. 

Short (4) Measure: 30 Measure: 36

Parallel Mild/mod/sev

N=58

Pustules (median) Short (4) Measure: 8 Measure: 10 NS

Comedones (median) Mid (12) Measure: 82 Measure: 47 NS

Infiltrates (median) Mid (12) Measure: 7 Measure: 5 NS

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Mid (12) Percent change: -70 Percent change: -67

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Between P-value: 1.0 < 0.5.

Mid (12) Percent change: -24 Percent change: -48 NS

185 Non-inflammatory change (%) Mid (12) Percent change: -81 (35.) Percent change: -73 

Parallel Mod (47.7)

È N=76

332 Papules (median)

Count location: Unspecified. 

Mid (12) Measure: 22 Measure: 18

Parallel Mild/mod/sev

"Signifi

cant"

N=58

Pustules (median) Mid (12) Measure: 6 Measure: 4 NS

Side effects (number) Mid (12) Measure: 6 Measure: 5 0.002

185 Non-inflammatory change (%) Long (16 Percent change: -88 

(15.4)

Percent change: -83 

Parallel Mod (34.1)

È N=76

 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 K 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

320 Inflammatory change/face (%)

Count location: Face unspecified. 

Long (20 Percent change: -90 Percent change: -77

Parallel Sev

N=150 0.01

Inflammatory change/trunk (%)

Count location: Back or chest unspecified. 

Long (20 Percent change: -56 Percent change: -68 0.01

Inflammatory change post therapy/face (%)

Count location: Face unspecified. 

Long (32 Percent change: -95 Percent change: -90 0.01

Inflammatory change/trunk post-therapy 

Count location: Back or chest unspecified. (%)

Long (32 Percent change: -78 Percent change: -80 0.01

185 Post-therapy non-inflammatory change (%) Long (32 Percent change: -94 

(14.7)

Percent change: -91

Parallel Mod

È N=76

 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 K CONTINUOUS: Page 7 of 7

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