Evidence Table E3: DISCRETE outcomes for class RETINOID (TOPICAL).

Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

E.01.01 Adapalene (0.03%) Adapalene (0.1%)

Severe erythema Present 0 NS

Absent 24

Present 1

Absent 23

338

Parallel 

Mild/mod/sev

N=72

È Mid (12)

E.01.02 Adapalene Tretinoin

Burning severity (patient) Very severe 0 0.02

Severe 0

Moderate 5

Slight 0

Very severe 0

Severe 4

Moderate 6

Slight 1

None 4

49

Parallel split 

face Mild/mod

N=15

È Short (2)

None 10

Desquamation severity (invesigator) Very severe 0 0.04

Severe 1

Moderate 5

Slight 7

Very severe 0

Severe 2

Moderate 6

Slight 5

None 2

Short (2)

None 2

Edema severity (invesigator) Very severe 0 NS

Severe 0

Moderate 0

Slight 1

Very severe 0

Severe 0

Moderate 0

Slight 1

None 14

Short (2)

None 14

Erythema severity (invesigator) Very severe 0 NS

Severe 0

Moderate 1

Slight 8

Very severe 0

Severe 0

Moderate 5

Slight 6

None 4

Short (2)

None 6

Papules severity (invesigator) Very severe 0 NS

Severe 1

Moderate 7

Slight 6

Very severe 0

Severe 0

Moderate 7

Slight 7

None 1

Short (2)

None 1

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 1 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Pruritis severity (patient) Very severe 0 0.02

Severe 0

Moderate 2

Slight 7

Very severe 0

Severe 0

Moderate 6

Slight 7

None 2

49

Parallel split 

face Mild/mod

N=15

È Short (2)

None 6

Tightness severity (patient) Very severe 0 0.02

Severe 1

Moderate 1

Slight 9

Very severe 0

Severe 1

Moderate 6

Slight 5

None 3

Short (2)

None 4

Vesicle severity (invesigator) Very severe 0 NS

Severe 0

Moderate 0

Slight 0

Very severe 0

Severe 0

Moderate 0

Slight 0

None 15

Short (2)

None 15

Adverse reations

Between P-value: compare of total 

number of reports

Irritation, erythema, dermatitis 6 0.05

Dry skin 4

Skin discomfort, pruritis 6

Acne flare 3

Irritation, erythema, dermatitis 12

Dry skin 13

Skin discomfort, pruritis 10

Acne flare 2

Infection, herpes 1

Sunburn 1

Total cutaneous 39

63

Parallel 

Mod/sev

N=591

È Mid (12)

Infection, herpes 0

Sunburn 0

total cutaneous 19

Discontinuation due to side effects Acne flare 2

Irritation 2

Dry skin 0

Acne flare 1

Irritation 4

Dry skin 2

Mid (12)

Burning Moderate 5 0.01

Severe 3

Other 129

Moderate 34

Severe 5

Other 95

80

Parallel 

N=268

Short (2)

Dryness Moderate 10

Severe 5

Other 119

Moderate 17

Severe 5

Other 112

Short (2)

Scaling Moderate 17

Severe 5

Other 112

Moderate 26

Severe 11

Other 97

Short (2)

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 2 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Burning Moderate 1 0.01

Severe 0

Other 133

Moderate 9

Severe 2

Other 123

80

Parallel 

N=268

È Mid (12)

Dryness Moderate 4 0.05

Severe 3

Other 127

Moderate 16

Severe 4

Other 114

Mid (12)

Scaling Moderate 9 0.05

Severe 3

Other 122

Moderate 12

Severe 2

Other 115

Mid (12)

Inter-treatment preference Easier to apply 80 0.001

Quickest to apply 58

Best smell 78

Feels the best 77

Easier to apply 20

Quickest to apply 40

Best smell 22

Feels the best 24

Feels less greasy 37

Prefer 38

93

Parallel split 

face Mild/mod

N=100

È Short (4)

Feels less greasy 66

Prefer 68

Intolerannce Short (4) Intolerance 32 Intolerance 70 0.001

Comedones change (count) 75% or greater improvement 14 NS

Less than 75% improvement 97

75% or greater improvement 10

Less than 75% improvement 106

100

Parallel Mod

N=297

Short (4)

Comedones change (count) 75% or greater improvement 36 NS

Less than 75% improvement 75

75% or greater improvement 26

Less than 75% improvement 100

Mid (12)

Dose regime altered Mid (12) Regime altered 25 Regime altered 20

Side effects

Between P-value: for burning and puritis

Discontinuation drug related 8 0.05

Discontinuation probably not drug 

related 4

Skin discomfort 16

Discontinuation drug related 4

Discontinuation probably not drug 

related 2

Skin discomfort 9

Mid (12)

Side effects Erythema 6

Dryness 11

Scaling 8

Immediate burning 2

Erythema 16

Dryness 15

Scaling 19

Immediate burning 19

Persistent burning 12

140

Parallel 

Mild/mod

N=105

Mid (12)

Persistent burning 3

Withdrawal due to side effects Mid (12) Irritation 1 Irritation 3

Severity change Non-inflammatory lesions 31

Total lesions 29

Inflammatory lesions 32

Non-inflammatory lesions 18

Total lesions 18

Inflammatory lesions 32

306

Parallel Mod

N=288

È Mid (12)

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 3 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

E.01.02 Adapalene (0.03%) Tretinoin

Severe erythema Present 0 NS

Absent 24

Present 1

Absent 23

338

Parallel 

Mild/mod/sev

N=72

È Mid (12)

E.01.02 Adapalene (0.1%) Tretinoin

Severe erythema Present 1 NS

Absent 23

Present 1

Absent 23

338

Parallel 

Mild/mod/sev

N=72

È Mid (12)

E.02.01 Isotretinoin Vehicle

Erythema score Grade 0 31

Grade 1 67

Grade 2 27

Grade 3 5

Grade 0 52

Grade 1 67

Grade 2 16

Grade 3 3

Grade 4 0

54

Parallel 

N=313

È Long (14

Grade 4 0

Peeling score Grade 0 38

Grade 1 69

Grade 2 20

Grade 3 3

Grade 0 67

Grade 1 58

Grade 2 12

Grade 3 1

Grade 4 0

Long (14

Grade 4 0

Local reactions I Scaling 7

Stinging 0

Itching 1

Peeling 4

Scaling 3

Stinging 2

Itching 0

Peeling 3

Erythema 1

Burning 0

Soreness 0

Dryness 0

173

Parallel 

Mild/mod

N=77

Mid (12)

Erythema 10

Burning 4

soreness 4

Dryness 3

Local reactions II Mid (12) Roughness 0 Roughness 1

E.02.01 Isotretinoin (0.05%) Vehicle

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 4 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

202 Side effects Erythema (withdraw) 1 Erythema (withdraw) 0 0.05

Parallel 

Mild/mod

N=82

Mid (12)

E.02.01 Isotretinoin (0.1%) Vehicle

202 Side effects Erythema (withdraw) 0 Erythema (withdraw) 0 0.05

Parallel 

Mild/mod

N=82

Mid (12)

E.02.02 Isotretinoin Benzoyl peroxide

Local reactions I Scaling 7

Stinging 0

Itching 1

Peeling 4

Scaling 7

Stinging 1

Itching 3

Peeling 2

Erythema 10

Burning 3

Soreness 3

Dryness 5

173

Parallel 

Mild/mod

N=77

È Mid (12)

Erythema 10

Burning 4

soreness 4

Dryness 3

Local reactions II Mid (12) Roughness 0 Roughness 1

E.02.03 Isotretinoin (0.05%) Isotretinoin (0.1%)

202 Side effects Erythema (withdraw) 1 Erythema (withdraw) 0 0.05

Parallel 

Mild/mod

N=82

Mid (12)

E.02.04 Isotretinoin Tretinoin

90 Irritation Present 7 Present 0

Parallel Mod

N=30

È Mid (12)

Stinging, erythema, desquamation Mid (12) Present 0 Present 10

Comedones change 75% or greater reduction 3 NS

25-75% reduction 2

25% or less reduction 3

75% or greater reduction 3

25-75% reduction 1

25% or less reduction 4

98

Parallel 

N=18

Mid (12)

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 5 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Inflammatory change (%) 75% or greater reduction 3 NS

25-75% reduction 3

25% or less reduction 2

75% or greater reduction 2

25-75% reduction 3

25% or less reduction 3

98

Parallel 

N=18

Mid (12)

Total lesions change (%) 75% or greater reduction 2 NS

25-75% reduction 5

25% or less reduction 1

75% or greater reduction 2

25-75% reduction 4

25% or less reduction 2

Mid (12)

E.03.01 Motretinide Vehicle

Overall change/physician Worse 2 NS

No change 13

Insufficient 11

Moderate 27

Worse 8

No change 12

Insufficient 9

Moderate 21

Good 17

Excellent 2

60

Parallel 

Mild/mod

N=257

Mid (8)

Good 19

Excellent 3

Reduction in application due to side 

effects

Mid (8) Reduced # application 10 Reduced # application 7 NS

Side effects Pruritis 34 NS

Burning 25

Erythema + desquamation 23

Desquamation to erythema 10

Pruritis 26

Burning 23

Erythema + desquamation 16

Desquamation to erythema 12

Erythema no desquamation. 14

No side effects 30

Local irritation (withdraw) 0

Mid (8)

Erythema no desquamation. 19

No side effects 23

local irritation (withdraw) 0

Total lesions change -1 (worse) 6 NS

0% 1

1-49% 23

50-74% 27

-1(worse) 4

0% 4

1-49% 22

50--74% 23

57-99% 14

100 (eradication) 1

Mid (8)

57-99% 18

100%(eradication) 2

Local reactions Desquamation without erythema 1 NS

Desquamation with erythema 3

Burning 2

Pruritis 4

Desquamation without erythema 2

Desquamation with erythema 4

Burning 4

Pruritis 7

61

Parallel 

N=19

Í Mid (8)

E.03.02 Motretinide (bid) Motretinide (qd)

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 6 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Overall change/physician Excellent 2 NS

Good 6

Moderate 8

Insufficient 2

Excellent 1

Good 8

Moderate 6

Insuffient 2

Unchanged 1

Aggravated 

253

Parallel 

Mod/sev

N=60

È Mid (8)

Unchanged 1

Aggravated 

E.03.03 Motretinide Tretinoin

Burning Present 2 0.05

Withdraw 0

Present 9

Withdraw 2

59

Parallel Mild

N=37

È Mid (8)

Erythema desquamation Mid (8) Present 7 Present 14 0.05

Total lesions Mid (8) Complete 6 Complete 6 NS

Overall change/physician Worse 2 NS

No change 13

Insufficient 11

Moderate 27

Worse 0

No change 3

Insufficient 9

Moderate 11

Good 34

Excellent 13

60

Parallel 

Mild/mod

N=257

Mid (8)

Good 19

Excellent 3

Reduction in application due to side 

effects

Mid (8) Reduced # application 10 Reduced # application 43 NS

Side effects Pruritis 34 NS

Burning 25

Erythema + desquamation 23

Desquamation to erythema 10

Pruritis 62

Burning 69

Erythema + desquamation 76

Desquamation to erythema 0

Erythema no desquamation. 6

No side effects 0

Local irritation (withdraw) 2

Mid (8)

Erythema no desquamation. 19

No side effects 23

local irritation (withdraw) 0

Total lesions change -1 (worse) 6 NS

0% 1

1-49% 23

50-74% 27

-1 (worse) 0

0% 2

1-49% 12

50-74% 19

57-99% 29

100% (eradication) 8

Mid (8)

57-99% 18

100%(eradication) 2

E.03.03 Motretinide (bid) Tretinoin

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 7 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Overall change/physician Excellent 2 NS

Good 6

Moderate 8

Insufficient 2

Excellent 3

Good 9

Moderate 5

Insufficient 1

Unchanged 

Aggravated 1

253

Parallel 

Mod/sev

N=60

È Mid (8)

Unchanged 1

Aggravated 

E.03.03 Motretinide (qd) Tretinoin

Overall change/physician Excellent 1 NS

Good 8

Moderate 6

Insuffient 2

Excellent 3

Good 9

Moderate 5

Insufficient 1

Unchanged 

Aggravated 1

253

Parallel 

Mod/sev

N=60

È Mid (8)

Unchanged 1

Aggravated 

E.04.01 Retinyl beta-glucuronide Vehicle

145 Adverse reaction Any 0 Any 0

Parallel 

Mild/mod

N=29

È Long (18

Non-responders Long (18 Non-responders 1 Non-responders 4

E.04.02 Retinyl beta-glucuronide Tretinoin

Adverse reaction Erythema, drying, peeling, 

cracking 0

Erythema, drying, peeling, cracking 

5

146

Parallel 

Mild/mod

N=15

È Long (28

Non-responders Long (28 Non-responders 1 Non-responders 0

E.05.01 Tretinoin Polyoprepolymer-2

Side effects Peeling 18 NS

Burning 14

Erythema 14

Tightness 34

Peeling 6

Burning 7

Erythema 9

Tightness 20

Itching 7

Dryness 7

219

Parallel 

Mild/mod

N=344

È Short (4)

Itching 16

Dryness 26

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 8 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Overall change/physician Excellent 25 NS

Fair to good 60

Excellent 10

Fair to good 30

219

Parallel 

Mild/mod

N=344

È Mid (12)

Side effects Peeling 9 NS

Burning 8

Erythema 9

Tightness 24

Peeling 2

Burning 1

Erythema 2

Tightness 13

Itching 4

Dryness 2

Mid (12)

Itching 15

Dryness 18

E.05.01 Tretinoin Vehicle

Overall change/physician Worse 0 0.0005

No change 3

Insufficient 9

Moderate 11

Worse 8

No change 12

Insufficient 9

Moderate 21

Good 17

Excellent 2

60

Parallel 

Mild/mod

N=257

Mid (8)

Good 34

Excellent 13

Reduction in application due to side 

effects

Mid (8) Reduced # application 43 Reduced # application 7 0.0005

Side effects Pruritis 62 0.005

Burning 69

Erythema + desquamation 76

Desquamation to erythema 0

Pruritis 26

Burning 23

Erythema + desquamation 16

Desquamation to erythema 12

Erythema no desquamation. 14

No side effects 30

Local irritation (withdraw) 0

Mid (8)

Erythema no desquamation. 6

No side effects 0

local irritation (withdraw) 2

Total lesions change -1 (worse) 0 0.0005

0% 2

1-49% 12

50-74% 19

-1(worse) 4

0% 4

1-49% 22

50--74% 23

57-99% 14

100 (eradication) 1

Mid (8)

57-99% 29

100% (eradication) 8

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 9 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Comedones severity Marked 12

Moderate 11

Slight 3

None 4

Marked 0

Moderate 2

Slight 17

None 8

Worse 0

270

Parallel 

N=61

Í Mid (8)

Worse 0

Improvement in papules Marked 2

Moderate 12

Slight 7

None 5

Marked 0

Moderate 0

Slight 7

None 20

Worse 0

Mid (8)

Worse 0

Improvement on pustules Marked 3

Moderate 4

Slight 12

None 5

Marked 0

Moderate 0

Slight 5

None 19

Worse 3

Mid (8)

Worse 2

Overall change Excellent 8

Good 9

Fair 7

Poor 3

Excellent 0

Good 0

Fair 7

Poor 20

Mid (8)

E.05.01 Tretinoin (0.02%) Vehicle

Side effects

Between P-value: with respect to placebo

58 Erythema/peeling 58 Erythema/peeling 31 0.001

Parallel Sev

N=256

Í Short (2)

Side effects Mid (8) Erythema/peeling 14 Erythema/peeling 4

E.05.01 Tretinoin (0.025%) Vehicle

Clinical assessment Marked improvement 10

Improved 11

Slight improvement 1

No change 0

Marked improvement 0

Improved 0

Slight improvement 1

No change 17

Worse 1

198

Parallel 

N=60

È Mid (12)

Worse 0

Side effects Soreness, erythema, irritation 

(withdraw) 0

Soreness, erythema, irritation 7

None 15

Soreness, erythema, irritation 

(withdraw) 0

Soreness, erythema, irritation 0

None 20

Mid (12)

E.05.01 Tretinoin (0.05%) Vehicle

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 10 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

58 Side effects Erythema/peeling 70 Erythema/peeling 31 0.001

Parallel Sev

N=256

Í Short (2)

Side effects Mid (8) Erythema/peeling 16 Erythema/peeling 4

Clinical assessment Marked improvement 3

Improved 11

Slight improvement 3

No change 0

Marked improvement 0

Improved 0

Slight improvement 1

No change 17

Worse 1

198

Parallel 

N=60

È Mid (12)

Worse 0

Side effects Soreness, erythema, irritation 

(withdraw) 1

Soreness, erythema, irritation 10

None 6

Soreness, erythema, irritation 

(withdraw) 0

Soreness, erythema, irritation 0

None 20

Mid (12)

E.05.01 Tretinoin (ethanol) Vehicle

Adverse effect Itching 9

Tightness 15

Burning 10

Erythema 28

Itching 4

Tightness 10

Burning 3

Erythema 13

Peeling 4

Dryness 8

220

Parallel 

Mild/mod

N=215

Short (4)

Peeling 26

Dryness 19

Any adverse outcome Skin/appendage adverse reaction 

13

Short (4) Skin/appendage adverse reaction 2

Adverse effects Itching 7

Tightness 9

Burning 7

Erythema 15

Itching 0

Tightness 6

Burning 1

Erythema 5

Peeling 2

Dryness 5

Mid (12)

Peeling 15

Dryness 15

Dry skin

Between P-value: .05 vs.tretinoin 

(polyolprepolymer-2), .05 vs. vehicle

Mid (12) Present 6 Present 0

Eruption Mid (12) Present 9 Present 2 NS

Other skin symptoms Severe (withdraw) 2

Stinging 1

Severe (withdraw) 0

Stinging 0

Mid (12)

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 11 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

220 Systemic adverse effects Any adverse event 29 Any adverse event 25 NS

Parallel 

Mild/mod

N=215

Mid (12)

E.05.01 Tretinoin (polyoprepolymer-2) Vehicle

Adverse effect Itching 11

Tightness 13

Burning 6

Erythema 16

Itching 4

Tightness 10

Burning 3

Erythema 13

Peeling 4

Dryness 8

220

Parallel 

Mild/mod

N=215

Short (4)

Peeling 12

Dryness 10

Any adverse outcome Skin/appendage adverse reaction 

11

Short (4) Skin/appendage adverse reaction 2

Adverse effects Itching 4

Tightness 6

Burning 3

Erythema 7

Itching 0

Tightness 6

Burning 1

Erythema 5

Peeling 2

Dryness 5

Mid (12)

Peeling 5

Dryness 6

Dry skin

Between P-value: vs. tretinoin(ethanol)

Mid (12) Present 1 Present 0 0.05

Eruption Mid (12) Present 8 Present 2 NS

Other skin symptoms Severe (withdraw) 0

Stinging 3

Severe (withdraw) 0

Stinging 0

Mid (12)

Systemic adverse effects Mid (12) Any adverse event 30 Any adverse event 25 NS

E.05.01 Tretinoin + polyoprepolymer-2 Polyoprepolymer-2

Side effects Peeling 26 NS

Burning 20

Erythema 20

Tightness 40

Peeling 6

Burning 7

Erythema 9

Tightness 20

Itching 7

Dryness 7

219

Parallel 

Mild/mod

N=344

È Short (4)

Itching 15

Dryness 26

Overall change/physician Excellent 29 NS

Fair to good 52

Excellent 10

Fair to good 30

Mid (12)

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 12 of 15

ÈÍ
Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Side effects Peeling 10 NS

Burning 8

Erythema 8

Tightness 18

Peeling 2

Burning 1

Erythema 2

Tightness 13

Itching 4

Dryness 2

219

Parallel 

Mild/mod

N=344

È Mid (12)

Itching 9

Dryness 15

E.05.02 Tretinoin Benzoyl peroxide

Side effects Erythema and irritation 1

Slight stinging 1

Erythema and soreness 1

Soreness 1

Pruritis 1

38

Parallel Mod

N=97

Í

Overall change/patient Improvement 35 0.001

No improvement 9

Improvement 14

No improvement 30

Mid (12)

Overall change/physician Improvement 38 0.001

No improvement 6

Improvement 19

No improvement 25

Mid (12)

E.05.02 Tretinoin Benzoyl peroxide (acetone)

Severity change Excellent 15 NS

Good 19

Fair 13

Poor 8

Excellent 20

Good 15

Fair 11

Poor 8

221

Parallel Mod

N=147

Í Mid (8)

E.05.02 Tretinoin Benzoyl peroxide (alcohol)

Adverse reaction Burning, erythema, peeling, severe 

10

None 44

Burning, erythema, peeling, severe 

20

None 18

221

Parallel Mod

N=147

Í Mid (8)

Severity change Excellent 15 NS

Good 19

Fair 13

Poor 8

Excellent 11

Good 8

Fair 11

Poor 8

Mid (8)

E.05.04 Tretinoin Azelaic acid

Erythema Present 40

Absent 106

Present 25

Absent 118

188

Parallel 

N=289

È Long (24

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 13 of 15

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Overall change/physician Excellent-good 60 NS

Moderate 18

Poor 20

Excellent-good 58

Moderate 20

Poor 21

188

Parallel 

N=289

È Long (24

Scaling Present 42

Absent 104

Present 24

Absent 119

Long (24

E.05.04 Tretinoin + vehicle Azelaic acid + glycolic acid

Side effects (patient assessment)

Between P-value: Dryness .001/Redness 

..037/ Peeling .001

Dryness 10

Redness 8

Peeling 5

Dryness 0

Redness 2

Peeling 0

316

Parallel Mild

N=70

Mid (12)

E.05.07 Tretinoin (0.02%) Tretinoin (0.05%)

Side effects

Between P-value: with respect to placebo

58 Erythema/peeling 58 Erythema/peeling 70 0.001

Parallel Sev

N=256

Í Short (2)

Side effects Mid (8) Erythema/peeling 14 Erythema/peeling 16

E.05.07 Tretinoin (0.025%) Tretinoin (0.05%)

Clinical assessment Marked improvement 10

Improved 11

Slight improvement 1

No change 0

Marked improvement 3

Improved 11

Slight improvement 3

No change 0

Worse 0

198

Parallel 

N=60

È Mid (12)

Worse 0

Side effects Soreness, erythema, irritation 

(withdraw) 0

Soreness, erythema, irritation 7

None 15

Soreness, erythema, irritation 

(withdraw) 1

Soreness, erythema, irritation 10

None 6

Mid (12)

E.06.01 Vitamin A Vehicle

Response Poor 9

Fair 7

Good 14

Excellent 20

Poor 11

Fair 6

Good 4

Excellent 4

34

Parallel 

Mild/mod

N=75

È Mid (12)

Side effects Mid (12) Erythema 47 Erythema & peeling 0

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 14 of 15

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Trial #

Method Info

Discrete Outcome Name (Units)

Definition/Comments

Between

P-value

Follow- Treatment Comparator

up (wks)

Comparison Attribute: Number of patient Attribute: Number of patients

Overall change Excellent 10

Good 12

Fair 6

Poor 3

Excellent 5

Good 8

Fair 11

Poor 10

35

Parallel 

Mild/mod

N=72

È Mid (12)

Overall change [female] Excellent 2 0.018

Good 7

Fair 1

Poor 1

Excellent 1

Good 5

Fair 3

Poor 3

Mid (12)

Overall change [male] Excellent 8 0.04

Good 5

Fair 5

Poor 2

Excellent 4

Good 3

Fair 8

Poor 7

Mid (12)

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

P-VALUE: comparison between Target and Comparator arms.

Evidence Table E DISCRETE: Page 15 of 15

ÈÍ