mild to moderate facial acne vulgarisclz-003 optimized clenziderm m.d. mild to moderate facial acne...

12 WEEK FINAL ANALYSIS

January 2012 JoAnne Watson, D.P.M. Associate Director Clinical Affairs

Barbara Coffey, Project Coordinator

CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS


CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION

OMPI JANUARY 2012 2

• Male or Female subjects between the ages of 12

through 25 years of age (inclusive);

• Mild to moderate facial acne (excluding the nose), with

normal skin: 17 to 40 inflammatory (papules, pustules,

and nodules), 10 to 100 non-inflammatory (open and

closed comedones), up to 2 nodulo-cystic lesions may

be present;

• A Physician’s Global Assessment of mild to moderate

(2 – 3)

MAIN INCLUSION CRITERIA



OMPI JANUARY 2012

N 22*

Gender Male (%) 68%

Gender Female (%) 32%

Age (Mean) 15.6

White/Caucasian (%) 81%

Black/African American (%) 5%

American Indian/Alaska Native (%) 5%

Caucasian & Asian (%) 9%

3

DEMOGRAPHICS

* All 22 subjects enrolled completed study



OMPI JANUARY 2012

Optimized CLENZIderm M.D.™ System

AM PM

(evening prior to bedtime)

• Daily Care Foaming Cleanser

(2% salicylic acid)

• Daily Care Foaming Cleanser

(2% salicylic acid)

• Pore Therapy (2% salicylic

acid)

• Therapeutic Lotion (5% BPO)

CLENZIderm M.D.™ Therapeutic Moisturizer was provided if needed for dryness or other

tolerability symptoms. Nu-Derm® Healthy Skin Protection SPF 35 sunscreen was provided

to use if exposed to sun.

STUDY TREATMENT REGIMEN

4

MJKelly

Rectangle



OMPI JANUARY 2012 5

EFFICACY



OMPI JANUARY 2012 6

• Non-Inflammatory Lesions = Open and Closed Comedones

• Inflammatory Lesions = Papules, Pustules and Nodules

• Total Lesions = Non-Inflammatory and Inflammatory Lesions

Lesion Definitions

• Open Comedone – Non-inflamed partially plugged hair follicle with dilated/open

orifice with a black surface

• Closed Comedone – Non-inflamed partially plugged hair follicle with a closed

orifice, white in color

• Papule – A solid, elevated inflammatory lesion less than 0.5 cm

• Pustule – An elevated inflammatory lesion less than 0.5 cm, contains pus

• Nodule/Cyst – Palpable solid inflammatory lesion, greater than 0.5 cm, has

depth, not necessarily elevated



OMPI JANUARY 2012

-23

-36 -39

-49 -47

-50

-40

-30

-20

-10

0

Day 7 Day 14 Day 28 Day 56 Day 84

7

LESION COUNTS – INFLAMMATORY LESIONS

% CHANGE FROM BASELINE

Mean

% C

han

ge

* *

* p ≤ 0.01 vs. Baseline

*

* *

Statistically significant reduction lesions all visits

Kelly

Rectangle



OMPI JANUARY 2012

-19 -20 -23

-20

-37

-40

-30

-20

-10

0


* *

8

LESION COUNTS – NON-INFLAMMATORY LESIONS


Mean

% C

han

ge

*

*


*


Kelly

Rectangle



OMPI JANUARY 2012

-21

-28 -31

-36

-44

-50

-40

-30

-20

-10

0


*

9

Mean

% C

han

ge

*

LESION COUNTS – TOTAL LESIONS


*


*

*


Kelly

Rectangle



OMPI JANUARY 2012

27

21

18 17

14 15

0

10

20

30

Baseline Day 7 Day 14 Day 28 Day 56 Day 84

10

TOTAL INFLAMMATORY LESION COUNT

Mean

Nu

mb

er

To

tal L

esio

ns


*

* *

* *



OMPI JANUARY 2012

34

27 27 27 27

21

0

10

20

30

40


11

TOTAL NON-INFLAMMATORY LESION COUNT

Mean

Nu

mb

er

To

tal L

esio

ns


*

* * * *



OMPI JANUARY 2012

62

47 44 44

40 35

0

10

20

30

40

50

60

70


12

TOTAL LESION COUNT (NON-INFLAMMATORY & INFLAMMATORY COMBINED)

Mean

Nu

mb

er

To

tal L

esio

ns


* *

* * *



OMPI JANUARY 2012

0 - Clear Normal, clear skin with no evidence of acne vulgaris

1 - Almost

Clear

Skin is almost clear: rare non-inflammatory lesions present, with rare non-

inflamed papules (papules must be resolving and may be hyperpigmented,

though not pink)

2 - Mild Some non-inflammatory lesions are present, with few inflammatory lesions

(papules/pustules only; no nodulo-cystic lesions)

3 - Moderate

Non-inflammatory lesions predominate, with multiple inflammatory lesions

evident: several to many comedones and papules/pustules, up to two

nodulo-cystic lesions may be present

4 - Severe Inflammatory lesions are more apparent: many comedones and

papules/pustules; there may or may not be a few nodulo-cystic lesions

5 - Very

Severe

Highly inflammatory lesions predominate: variable number of comedones,

many papules/pustules nodulo-cystic lesions

13

PHYSICIAN GLOBAL ASSESSMENT SCALE



OMPI JANUARY 2012

1

2

3

4


14

2-Mild

1-Almost

Clear

3-Moderate

4-Severe

Mean Value at

Each Visit

Scale

Clear (0)

Almost Clear (1)

Mild (2)

Moderate (3)

Severe(4)

Very Severe (5)

PHYSICIAN GLOBAL ASSESSMENT



OMPI JANUARY 2012 15

TOLERABILITY



OMPI JANUARY 2012

0 None – no erythema present (may be minor discoloration)

1 Mild – light pink, noticeable

2 Moderate – pink-red, easily noticeable

3 Severe – deep or bright red, may be warm to the touch

16

TOLERABILITY - ERYTHEMA



OMPI JANUARY 2012

0

1

2

3

Baseline 7 14 28 56 84Day

17

TOLERABILITY - ERYTHEMA

Mild

None

Moderate

Severe

Mean

Sco

re



OMPI JANUARY 2012

0 20 40 60 80 100

Baseline

Day 7

Day 14

Day 28

Day 56

Day 84

45

54

63

45

52

73

50

32

23

41

43

23

5

14

14

14

5

5

None

Mild

Moderate

Percentage of Subjects

18

TOLERABILITY ASSESSMENTS BY VISIT

Ery

them

a



OMPI JANUARY 2012

0 None – no dryness present

1 Mild – slight but definite roughness

2 Moderate – moderate roughness

3 Severe – marked roughness

19

TOLERABILITY - DRYNESS



OMPI JANUARY 2012

0

1

2

3


20

TOLERABILITY - DRYNESS

Mild

None

Moderate

Severe

Mean

Sco

re



OMPI JANUARY 2012

0 20 40 60 80 100

Baseline

Day 7

Day 14

Day 28

Day 56

Day 84

50

59

54

59

67

59

41

27

46

36

29

36

9

14

5

5

5

None

Mild

Moderate

Severe


21


Dry

ness

(Day 28 1 Subject Severe Dryness)



OMPI JANUARY 2012

0 None – no peeling present

1 Mild – slight peeling

2 Moderate – definitely noticeable peeling

3 Severe – extensive peeling

22

TOLERABILITY - PEELING



OMPI JANUARY 2012

0

1

2

3

Baseline 7 14 28 56 84

Day

23

TOLERABILITY - PEELING

Mild

None

Moderate

Severe

Mean

Sco

re



OMPI JANUARY 2012

0 20 40 60 80 100

Baseline

Day 7

Day 14

Day 28

Day 56

Day 84

63

73

68

82

76

86

32

14

27

13

19

14

5

14

5

5

5 None

Mild

Moderate


24


Peelin

g

(Day 28 1 Subject Severe Dryness)



OMPI JANUARY 2012

0 None – no stinging/burning

1 Mild – light warm, tingling sensation, not really bothersome

2 Moderate – definite warmth, tingling/stinging sensation that

is somewhat bothersome

3 Severe – hot tingling/stinging sensation which is disturbing

normal activity

25

TOLERABILITY – STINGING/BURNING



OMPI JANUARY 2012

0

1

2

3


26

TOLERABILITY – STINGING/BURNING

Mild

None

Moderate

Severe

Mean

Sco

re



OMPI JANUARY 2012

0 20 40 60 80 100

Baseline

Day 7

Day 14

Day 28

Day 56

Day 84

100

27

68

77

76

82

27

18

23

14

14

46

14

10

5

None

Mild

Moderate


27


Sti

ng

ing

/Bu

rnin

g



OMPI JANUARY 2012

0 None – no itching

1 Mild – occasional, slight itching

2 Moderate – constant or intermittent itching that is somewhat

bothersome

3 Severe – bothersome itching which is disturbing normal

activity

28

TOLERABILITY – ITCHING



OMPI JANUARY 2012

0

1

2

3


29

TOLERABILITY – ITCHING

Mild

None

Moderate

Severe

Mean

Sco

re



OMPI JANUARY 2012

20 40 60 80 100

Baseline

Day 7

Day 14

Day 28

Day 56

Day 84

100

100

100

95

100

95

5

5

None

Mild

Moderate


30


Itch

ing




SUBJECT

QUESTIONNAIRES



OMPI JANUARY 2012

ADVERSE EVENT DESCRIPTION

AE INTENSITY

TOTAL # SUBJECTS

Facial Dryness and Peeling*

Severe 1

32

TREATMENT RELATED ADVERSE EVENTS

* Rated by Investigator, no treatment required by subject




SUBJECT SELF-ASSESSED ACNE IMPROVEMENT (Good, Very Good & Excellent)

46 50 50

2414

914

32

48

27

5

5

510

32

0

20

40

60

80

100


Excellent

Very Good

Good

60% 69%

87% 82%

73%

Subje

cts

(%

)




9

0

5 5

9

32 32

9

14

18

46

50 50

24

14

9

14

32

48

27

5 5 5

10

32

0

10

20

30

40

50

60


0-Poor

1-Fair

2-Good

3-Very Good

4-Excellent

SUBJECT SELF-ASSESSED ACNE IMPROVEMENT

Subje

cts

(%

)




SUBJECT SELF-ASSESSED

SATISFACTION OF ACNE IMPROVEMENT (Satisfied + Very Satisfied)

4150 46

62

27

9

14 27

19

46

0

20

40

60

80

100


Very Satisfied

Satisfied

50%

64% 73%

81% 81%

Subje

cts

(%

)

mcaruso

Rectangle




0 0 0 0 0

14

5 5

10 9

36

32

23

10

18

41

50

46

62

27

9

14

27

19

46

0

10

20

30

40

50

60

70


1-Dissatisfied

2-Indifferent

3-Somewhat Satisfied

4-Satisfied

5-Very Satisfied


SATISFACTION OF ACNE IMPROVEMENT

Subje

cts

(%

)




SUBJECT QUESTIONNAIRES EFFECTIVENESS OF TREATMENT PRODUCTS

(Very Effective + Effective)

5059 55 60

46

149

27 2041

0

20

40

60

80

100


Very Effective

Effective

64% 68%

82% 80% 87%

Subje

cts

(%

)

Kelly

Rectangle

MJKelly

Rectangle




5 5

0

9

32 32

14

20

5

50

59

55

60

46

14

9

27

20

41

0

20

40

60

80


1-Ineffective

2-Somewhat Effective

3-Effective

4-Very Effective


EFFECTIVENESS OF TREATMENT PRODUCTS

Subje

cts

(%

)



OMPI JANUARY 2012

64 64

59 62

59

18

14

18

5 5 5 5 5 10 9

14

18 18

24 27

0

10

20

30

40

50

60

70


N/A

1-Less Effective

2-As Effective

3-More Effective

*Subjects

rating

parameter

as “as

effective”

or “more

effective”

(%)

39

TREATMENT PRODUCT VS. OTHER

Rx PRODUCTS USED IN PAST

*19%

*23%

*36%

*23%

*34%



OMPI JANUARY 2012

46

41 41

48

41

18

14

18

10

14

18

14

5 0 9

18

32

36

43

36

0

10

20

30

40

50

60


N/A

1-Less Effective

2-As Effective

3-More Effective

*43%

*46%

*Subjects

rating

parameter

as “as

effective”

or “more

effective”

(%)

40

TREATMENT PRODUCT VS. OTHER

OTC PRODUCTS USED IN PAST

*36%

*46% *41%




SUBJECT PHOTOS

BASELINE DAY 14

OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD NSL, 002

BASELINE DAY 28

OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD NSL, 002

BASELINE DAY 14

OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBH, 004

BASELINE DAY 28


Kelly

Rectangle

BASELINE DAY 84


BASELINE DAY 84

OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBM, 006

BASELINE DAY 7

OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DMR, 009

BASELINE DAY 14


BASELINE DAY 28


BASELINE DAY 84


BASELINE DAY 84

OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MYW, 018

BASELINE DAY 84

OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DGV, 022



OMPI JANUARY 2012

• Statistically significant reduction in lesions all time points

• Clinically visible signs reduction acne within 2 weeks

• Well tolerated (by week 2 mean erythema, peeling, dryness,

stinging/burning, itching was between “none” and “mild”)

• 81% subjects self assessed very satisfied or satisfied with their acne

improvement

• 87% subjects self assessed regimen very effective or effective at

Day 84 (82% at Day 28)

• 73% subjects self assessed very good or good acne improvement at

Day 84 (82% at Day 28)

• Pump delivery problems Therapeutic Lotion and leaking Pore

Therapy bottles impacted compliance

64

CONCLUSIONS

mild to moderate facial acne vulgarisclz-003 optimized clenziderm m.d. mild to moderate facial acne...

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