mild to moderate facial acne vulgarisclz-003 optimized clenziderm m.d. mild to moderate facial acne...
TRANSCRIPT
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
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 5
EFFICACY
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
-19 -20 -23
-20
-37
-40
-30
-20
-10
0
Day 7 Day 14 Day 28 Day 56 Day 84
* *
8
LESION COUNTS – NON-INFLAMMATORY LESIONS
% CHANGE FROM BASELINE
Mean
% C
han
ge
*
*
* p ≤ 0.01 vs. Baseline
*
Statistically significant reduction lesions all visits
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
-21
-28 -31
-36
-44
-50
-40
-30
-20
-10
0
Day 7 Day 14 Day 28 Day 56 Day 84
*
9
Mean
% C
han
ge
*
LESION COUNTS – TOTAL LESIONS
% CHANGE FROM BASELINE
*
* p ≤ 0.01 vs. Baseline
*
*
Statistically significant reduction lesions all visits
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
* p ≤ 0.01 vs. Baseline
*
* *
* *
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
34
27 27 27 27
21
0
10
20
30
40
Baseline Day 7 Day 14 Day 28 Day 56 Day 84
11
TOTAL NON-INFLAMMATORY LESION COUNT
Mean
Nu
mb
er
To
tal L
esio
ns
* p ≤ 0.01 vs. Baseline
*
* * * *
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
62
47 44 44
40 35
0
10
20
30
40
50
60
70
Baseline Day 7 Day 14 Day 28 Day 56 Day 84
12
TOTAL LESION COUNT (NON-INFLAMMATORY & INFLAMMATORY COMBINED)
Mean
Nu
mb
er
To
tal L
esio
ns
* p ≤ 0.01 vs. Baseline
* *
* * *
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
1
2
3
4
Baseline Day 7 Day 14 Day 28 Day 56 Day 84
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 15
TOLERABILITY
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
0
1
2
3
Baseline 7 14 28 56 84Day
17
TOLERABILITY - ERYTHEMA
Mild
None
Moderate
Severe
Mean
Sco
re
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
0
1
2
3
Baseline 7 14 28 56 84Day
20
TOLERABILITY - DRYNESS
Mild
None
Moderate
Severe
Mean
Sco
re
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
Percentage of Subjects
21
TOLERABILITY ASSESSMENTS BY VISIT
Dry
ness
(Day 28 1 Subject Severe Dryness)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
0 None – no peeling present
1 Mild – slight peeling
2 Moderate – definitely noticeable peeling
3 Severe – extensive peeling
22
TOLERABILITY - PEELING
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
0
1
2
3
Baseline 7 14 28 56 84
Day
23
TOLERABILITY - PEELING
Mild
None
Moderate
Severe
Mean
Sco
re
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
Percentage of Subjects
24
TOLERABILITY ASSESSMENTS BY VISIT
Peelin
g
(Day 28 1 Subject Severe Dryness)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
0
1
2
3
Baseline 7 14 28 54 84Day
26
TOLERABILITY – STINGING/BURNING
Mild
None
Moderate
Severe
Mean
Sco
re
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
Percentage of Subjects
27
TOLERABILITY ASSESSMENTS BY VISIT
Sti
ng
ing
/Bu
rnin
g
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012
0
1
2
3
Baseline 7 14 28 56 84Day
29
TOLERABILITY – ITCHING
Mild
None
Moderate
Severe
Mean
Sco
re
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
Percentage of Subjects
30
TOLERABILITY ASSESSMENTS BY VISIT
Itch
ing
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 31
SUBJECT
QUESTIONNAIRES
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 33
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
Day 7 Day 14 Day 28 Day 56 Day 84
Excellent
Very Good
Good
60% 69%
87% 82%
73%
Subje
cts
(%
)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 34
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
Day 7 Day 14 Day 28 Day 56 Day 84
0-Poor
1-Fair
2-Good
3-Very Good
4-Excellent
SUBJECT SELF-ASSESSED ACNE IMPROVEMENT
Subje
cts
(%
)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 35
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
Day 7 Day 14 Day 28 Day 56 Day 84
Very Satisfied
Satisfied
50%
64% 73%
81% 81%
Subje
cts
(%
)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 36
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
Day 7 Day 14 Day 28 Day 56 Day 84
1-Dissatisfied
2-Indifferent
3-Somewhat Satisfied
4-Satisfied
5-Very Satisfied
SUBJECT SELF-ASSESSED
SATISFACTION OF ACNE IMPROVEMENT
Subje
cts
(%
)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 37
SUBJECT QUESTIONNAIRES EFFECTIVENESS OF TREATMENT PRODUCTS
(Very Effective + Effective)
5059 55 60
46
149
27 2041
0
20
40
60
80
100
Day 7 Day 14 Day 28 Day 56 Day 84
Very Effective
Effective
64% 68%
82% 80% 87%
Subje
cts
(%
)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 38
5 5
0
9
32 32
14
20
5
50
59
55
60
46
14
9
27
20
41
0
20
40
60
80
Day 7 Day 14 Day 28 Day 56 Day 84
1-Ineffective
2-Somewhat Effective
3-Effective
4-Very Effective
SUBJECT SELF-ASSESSED
EFFECTIVENESS OF TREATMENT PRODUCTS
Subje
cts
(%
)
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
Day 7 Day 14 Day 28 Day 56 Day 28
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%
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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
Day 7 Day 14 Day 28 Day 56 Day 84
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%
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
OMPI JANUARY 2012 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
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBH, 004
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBH, 004
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBH, 004
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBH, 004
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBM, 006
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MBM, 006
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
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DMR, 009
BASELINE DAY 28
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DMR, 009
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DMR, 009
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DMR, 009
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DMR, 009
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MYW, 018
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD MYW, 018
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
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DGV, 022
BASELINE DAY 84
OMP, INC. CLZ003 - SITE #1 LEONARD SWINYER, MD DGV, 022
CLZ-003 OPTIMIZED CLENZIDERM M.D. MILD TO MODERATE FACIAL ACNE VULGARIS
CONFIDENTIAL INTERNAL OMP CORPORATE USE ONLY - NOT FOR DISTRIBUTION
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