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NORTH CAROLINA DERMATOLOGY ASSOCIATION
2017 SUMMER MEETING
This continuing medical education activity is jointly provided by theNorth Carolina Dermatology Association and
Southern Regional Area Health Education Center FRIDAY HANDOUTS
JULY 7-9, 2017 | OMNI HOMESTEAD RESORT | HOT SPRINGS, VIRGINIA
1
Medical and DiagnosticPearls
Mark Lebwohl, MD
Sol and Clara Kest ProfessorAnd Chairman
Department of DermatologyThe Mount Sinai School of Medicine
Mount Sinai gets dollars from:
• Abbvie
• Amgen
• Boehringer Ingelheim
• Celgene
• Eli Lilly
• Janssen / Johnson & Johnson
• Kadmon
• Medimmune/Astra Zeneca
• Novartis
• Pfizer
• ViDac.
Consultant
• Allergan
• Dr. Reddy
• Pruritus in the elderly
• Lichen planus
• Ostomies
• Raynaud’s phenomenon
• Optimal phraseology for patients
• Actinic Keratoses
• Local anesthesia alternatives
• Tool tips
• Management of bleeding
2
• Patient with hyperverbia profundia
• Ocular rosacea
• Gingival hyperplasia
• Drug sampling
• Lyme disease
• Defibrillators
• Nickel allergy
• Atopic dermatitis
Chronic eczematous eruptions of the elderly are associated with chronic exposure to calcium channel blockers: results from a case-control study.Joly P, Benoit-Corven C, Baricault S, Lambert A, Hellot MF, Josset V, Barbaud A, Courville P, Delaporte E, Collet E, Carvalho P, Modeste-Duval AB, Lacour JP, L'Anthoën-Arditi MH, Thuillez C, Benichou J.J Invest Dermatol. 2007;127:2766-71.
[Lisinopril-induced erythroderma] Schmutz JL, Barbaud A, Tréchot P. Ann Dermatol Venereol. 2009;136:486. Epub 2009 Apr 3. French
3
ACE-I induced angioedema: a casereport and review of literature.Adebayo PB, Alebiosu OC.Cases J. 2009;2:7181.
Angiotensin-converting enzymeinhibitors as inducers of adversecutaneous reactions.Steckelings UM, Artuc M, Wollschläger T, Wiehstutz S, Henz BM.
Acta Derm Venereol. 2001;81:321-5.
Enalapril and vulvovaginal pruritus.Heckerling PS.Ann Intern Med. 1990;112:879-80.
4
Rash, eosinophilia, and hyperkalaemiaassociated with enalapril.Barnes JN et al.
Lancet. 1983;2:41-2.
[Captopril-induced eruptions: occurrence over a 3-year period] Daniel F, Foix C, Barbet M, Schwebig A, Plouin F, Ménard J, Baviera A.Ann Dermatol Venereol. 1983;110:441-6.French
LichenplanusGlsb
388
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,em neu1e hdplll u bo:l1tne.
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JJV,emlc CICJ1tlaictm> • 50 Ill.!! tW'a for 20-60 dJ}1hz p oh tn mimr p:.ntmrL In FJlr:m v.tlo do not tepood,t'l'JI J'ffi JD-OOmgwuy rtlT 2-wmu, or 111 equJ,·.ilent, Clpcn!dlbcensu'I 2-6 wcdi II o f t u dl t c . t h UnflmuJUt • C\TDtnp;axllls 11bo eJr wtlb qumm di, M U p 1e ttequrnt. It pllknll 111qulrr 11101'
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SPECACI ST IJIIS
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5
Topica.l corticosteroidslntralesional corticosteroids Antihistamines
C
D
C
MetronidazoleSystemic corticosteroids lsotretinoin, acitretin Narrowband or broad band UVB PUVA
C
B
A
C
C
Oral metronidazole treatment of lichen planus.Büyük AY, Kavala M.J Am Acad Dermatol. 2000;43(2 Pt 1):260-2.
• Metronidazole 500 mg bid x 20-60 d.
• 15/19 (79%) improved
• 13/15 → complete clearing
6
Efficacy of sulfasalazine in the treatment of generalized lichen planus: randomized double-blinded clinical trial on 52 patients.Omidian M, Ayoobi A, Mapar MA, Feily A,Cheraghian B.JEADV. 2010;24:1051-1054(4).
• sulfasalazine up to 2.5g/d vs. placebo x 6w• lesion improvement 82.6% vs. 9.6%• pruritus improvement 91.3% vs. 14.3%• side effects 30.7% - GI and HA
“Small fistula tracks … from which pus could be obtained on pressure.”
Brunsting LA, Goeckerman WH, O'Leary PAArch Dermatol Syph. 1930; 22:655
If you’re confident about a patient’s diagnosis and treatment, let them
know you see a lot of this condition and know exactly how to deal
with it.• Mycosis fungoides/CTCL
• Perioral dermatitis
7
Bilateral comparison of the efficacy and tolerability of 3% diclofenac sodium gel and 5% 5-fluorouracil cream in the treatment of actinic keratoses of the face and scalp.Smith SR, Morhenn VB, Piacquadio DJ.
J Drugs Dermatol. 2006;5:156-9.
• Both work
• Diclofenac less irritating
Imiquimod 5% cream for the treatment of actinic keratosis: results from two phase III, randomized, double-blind, parallel group, vehicle-controlled trials.
Lebwohl M, Dinehart S, Whiting D, Lee PK, Tawfik N, Jorizzo J, Lee JH, Fox TL.
J Am Acad Dermatol. 2004;50:714-21.
imiquimod cream biw x 16w.
Ingenol mebutate gel for actinic keratosis.
Lebwohl M, Swanson N, Anderson LL, Melgaard A, Xu Z, Berman B.
N Engl J Med. 2012;366(11):1010-9.
8
Composite LSR Scoresa Through Day57:Safety Population
22
Mean composite LSR scores peaked at day 4and returned to baseline levels by day 15.
aThe composite LSR score represents the sum of the scores for the 6 specific types of LSRs graded from 0 to 4, with a maximum score of 24 at each study visit.
Pooled 016 and 025
Long-term follow-up of photodynamic therapy with a self-adhesive 5-aminolaevulinic acid patch: 12 months data.Szeimies RM, et al
Br J Dermatol. 2010;162:410-4.
• PDT – 1 rx: 63% and 79% efficacy at 1 yr
• Placebo PDT: 9% and 25%
• Cryosurgery: 63%
A randomised study of topical 5% imiquimod vs. topical 5-fluorouracil vs. cryosurgery in immunocompetent patients with actinic keratoses: a comparison of clinical and histological outcomes including 1-year follow-up
Krawtchenko N, Roewert-Huber J, UlrichM, Mann I, Sterry W, Stockfleth E.
British Journal of Dermatology.2007;157(s2):34-40.
9
• Cryo 20-40 sec per lesion x 1-2sessions
• 5FU bid x 4w.
• Imiquimod tiw x 4 w. x 1-2 courses
Clinical Evaluation:Comparison of All Treatment Groups
68%
96%85%
4%100%
80%
60%
40%
20%
0%
Imiquimod 5-FU Cryotherapy
Pat
ien
ts (
%)
Cleared Persistent
Krawtchenko et al. Br J Dermatol 2007;157(suppl. 2):34-40
p=.03 Imiquimod (n=26) 5-FU (n=24) Cryosurgery (n=25)
Histological Confirmation: Comparisonof All Treatment Groups
32%
67%73%
100%
80%
60%
40%
20%
0%
Pat
ien
ts (
%)
Cleared Persistent
Krawtchenko et al. Br J Dermatol 2007;157(suppl. 2):34-40
Biopsies are checked by 2 independent histopathologists
p=.03 for 5-FU and p=.008 for imiquimod
Imiquimod(n= 26)
5-FU(n= 24)
Cryotherapy(n= 25)
10
Sustained Clearance of Initially ClearedLesions in All Patients
Pat
ien
ts (
%)
Twelve months after end of treatment
80%
73%60%
40%
20%
0%Imiquimod (n=26) 5-FU (n=24) Cryotherapy (n=25)
Krawtchenko et al. Br J Dermatol 2007;157(suppl. 2):34-40
p<.01
Out of all treated patients (including in the denominator also those not cleared at end of therapy)
Severe refractory fingertip ulcerations in a patient with scleroderma: successful treatment with sildenafil.Colglazier CL, Sutej PG, O'Rourke KS.
J Rheumatol. 2005;32:2440-2.
Statins: Potentially useful in therapy of systemic sclerosis-related Raynaud’s Phenomenon and digital ulcers.Abou-Raya A et al.J Rheumatol 2008;35:1801-8.
• Atorvastatin 40/d vs placebo x 4 mos
• new ulcers: 1.6 vs 2.5
• RP, pain and severity of ulcers,
endothelial damage markers
11
Botox therapy for ischemic digits.Neumeister MW et al.Plast Reconstr Surg. 2009;124:191.
• 100 unit botulinum toxin vial dilutedin 2cc preservative-free saline
• 50-100 U of toxin injected into palm around neuromuscular bundles at MCP
Neumeister MW et al.Plast Reconstr Surg. 2009;124:191.
• pain relief was immediate• ulcers healed within 2 months• Doppler showed increased blood flow
within 30 minutes• pain relief persisted in 12/19 at 13-59
months
Management of vasospastic disorders withbotulinum toxin A.Van Beek AL et al.Plast Reconstr Surg. 2007;119:217-26.
• 11 patients, painful Raynaud’s, digital ulcerations.
• Failed vasodilators, anti-platelet agents,and IV prostacyclin.
12
Botox 100 U at 8-10 sites,perivascular digital and palmar.
• Temporary hand weakness in 3 patients.• All patients improved:• Less frequent and less severe vasospasm
and cyanosis within 48 hours.PreRx scores: 9-10PostRx: 0-2
Van Beek AL et al.Plast Reconstr Surg. 2007;119:217-26
Increased sensitivity to thermal painand reduced subcutaneous lidocaineefficacy in redheads.Liem EB et al.
Anesthesiology. 2005;102:509-14.
Tip # 8
Anesthetic requirement is increased in redheads.Liem EB et al.
Anesthesiology. 2004;101:279-83.
13
• Diphenhydramine– 50mg/mL (5%) Dilute 1:5 ( 1%)
– Lasts ~20 minutes
– Risk of necrosis and delayed sedation
• Bacteriostatic saline w/0.9% benzyl alcohol
– Sufficient volume and pressure
– Lasts ~2 minutes
Alternative Local Anesthetics
Tip # 9
Injectable sodium chloride as a local anesthetic for skin surgery.
Weiner SGCutis. 1979; :342-3.
“parallel scalpel technique, razor technique, orcurettage…punch biopsies and electrocauterytechniques”
Diphenhydramine versus lidocaine as alocal anesthetic.
Dire DJ, Hogan DE.Ann Emerg Med. 1993;22:1419-22.
• No significant differences btwn 1% lidocaineand 1% diphenhydramine injections for localanesthesia.
14
Lidocaine versus diphenhydramine for anesthesia in the repair of minor
lacerations.Ernst AA, et al.
J Trauma. 1993;34:354-7.
• 1% diphenhydramine more painful than 1% lidocaine, but anesthesia is equivalent
Reasons to Become a Registry Investigator
• Contribute to education/clinical knowledge of the psoriasiscommunity
• Opportunity to establish a database of your patient population
• Academic recognition and publication opportunities
• Supplement existing insurance fee schedules– Site compensation is $400 (including $20 for patient) per Enrollment
visit and $300 (including $20 for patient) per biannual Follow Up visit
41
If you are interested in participating in the Psoriasis Registry as a research investigator, please email
psoriasis@corrona.orgor visit www.corrona.org
or call 508.408.5432
Become a Registry Research Investigator
1
Breakthrough Drugs inDermatology
Mark Lebwohl, MDSol and Clara Kest Professor
And ChairmanKimberly and Eric J. Waldman Department of Dermatology
Icahn School of Medicine at Mount Sinai
LIFE CHANGING MEDICATIONS• New psoriasis therapies
•Dupilumab
•Omalizumab
•Vismodegib/Sonidegib
• Penetration enhancers that improve topicaltherapy
• JAKinhibitors
• New vitiligotherapies
Drugs for Psoriasis and Psoriatic Arthritis
• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB
• GOLIMUMAB
• USTEKINUMAB
• SECUKINUMAB
• IXEKIZUMAB
• APREMILAST
• METHOTREXATE
• CYCLOSPORINE
• ACITRETIN
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
2
Drugs for Psoriasis and Psoriatic Arthritis-ORAL• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB
• GOLIMUMAB
• USTEKINUMAB
• SECUKINUMAB
• IXEKIZUMAB
• APREMILAST
• METHOTREXATE
• CYCLOSPORINE
• ACITRETIN
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
Drugs for Psoriasis and Psoriatic Arthritis-FEW INJECTIONS
• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB
• GOLIMUMAB
• USTEKINUMAB• SECUKINUMAB
• IXEKIZUMAB
• APREMILAST
• METHOTREXATE
• CYCLOSPORINE
• ACITRETIN
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
Drugs for Psoriasis and Psoriatic Arthritis –LONG Hx & ↓ CARDIAC DISEASE
• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB
• GOLIMUMAB• USTEKINUMAB
• SECUKINUMAB
• IXEKIZUMAB
• APREMILAST
• METHOTREXATE
• CYCLOSPORINE
• ACITRETIN
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
3
Drugs for Psoriasis and Psoriatic Arthritis –OBESITY:ADJUST FOR WEIGHT
• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB• CERTOLIZUMAB
• GOLIMUMAB
• USTEKINUMAB• SECUKINUMAB
• IXEKIZUMAB
• APREMILAST
• METHOTREXATE
• CYCLOSPORINE
• ACITRETIN
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
Drugs for Psoriasis and Psoriatic Arthritis –OBESITY:ADJUST FOR WEIGHT
• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB• GOLIMUMAB
• USTEKINUMAB
• SECUKINUMAB• IXEKIZUMAB
• APREMILAST
• METHOTREXATE
• CYCLOSPORINE
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
Drugs for Psoriasis and Psoriatic Arthritis –OBESITY
• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB• GOLIMUMAB
• USTEKINUMAB
• SECUKINUMAB
• IXEKIZUMAB
• APREMILAST
• METHOTREXATE
• CYCLOSPORINE
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
4
Drugs for Psoriasis and Psoriatic Arthritis-PSA• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB
• GOLIMUMAB• USTEKINUMAB• SECUKINUMAB
• IXEKIZUMAB
• APREMILAST
• METHOTREXATE• CYCLOSPORINE
• ACITRETIN
• BRODALUMAB
• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
Drugs for Psoriasis and Psoriatic Arthritis-PSA• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB
• GOLIMUMAB• USTEKINUMAB
• SECUKINUMAB
• IXEKIZUMAB• APREMILAST
• METHOTREXATE• CYCLOSPORINE
• BRODALUMAB• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
Drugs for Psoriasis and Psoriatic Arthritis- FAST• ETANERCEPT
• ADALIMUMAB
• INFLIXIMAB
• CERTOLIZUMAB
• GOLIMUMAB
• USTEKINUMAB
• SECUKINUMAB
• IXEKIZUMAB• APREMILAST
• METHOTREXATE
• CYCLOSPORINE• ACITRETIN
• BRODALUMAB• GUSELKUMAB
• TILDRAKIZUMAB
• RISANKIZUMAB
• LY3074828
SPEED
5
100
90
80
70
60
50
40
30
20
10
0
Dupilumab Phase 2b Study:Proportion of Patients Achieving ≥75% ImprovementFrom Baseline in EASI (EASI-75†) Over 16 Weeks
11.5
29.2
60.355.753.149.2
†Observed value with censoring after rescue medication; missing treated as non-responder. EASI: Eczema and Severity Index; q2w: every 2 weeks; q4w,:every 4 weeks.Adapted from Thaci D et al. Lancet. 2016;387(10013):4052.
0 4 8 12 16Week
P < 0.05 vs placebo, Weeks 23 and P ≤ 0.0001 vs placebo, Weeks 416
P < 0.05 vs placebo, Weeks 26 and P ≤ 0.0001 vs placebo, Weeks 816
P < 0.05 vs placebo, Week 2 and P ≤ 0.00001 vs placebo, Weeks 316
P < 0.05 vs placebo, Weeks 23 and Weeks 816; P ≤ 0.0001 vs placebo, Weeks 4 and 6; and P = 0.0147 vs placebo, Week 16
PlaceboDupilumab 100 mg q4wDupilumab 300 mg q4wDupilumab 200 mg q2wDupilumab 300 mg q2w Dupilumab 300 mg weekly
Pro
po
rtio
no
f p
ati
ents
a
ch
ievi
ng
EA
SI-
75(%
)
Dupilumab SOLO 1 & 2: Proportion (%) of Patients with IGA0 or 1 and ≥ 2-point Reduction From Baseline at week 16
10
0
10
20
30
40
50
Per
cen
to
f p
atie
nts
ach
ievi
ng
IGA
≤1
SOLO 1
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
8.5
0
10
20
30
40
50
Per
cen
to
f p
atie
nts
ach
ievi
ng
IGA
≤1
SOLO 2
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
38* 37* 36* 36*
* P<0.0001.IGA: investigator’s global assessment; qw: weekly; q2w: every 2 weeks.
15
0
10
20
30
40
50
60
Per
cen
tp
atie
nts
ach
ievi
ng
EA
SI-
75
SOLO 1
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
12
4448
0
10
20
30
40
50
60
Per
cen
tp
atie
nts
ach
ievi
ng
EA
SI-
75
SOLO 2
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
51* 52.5*
*
*
* P<0.0001.EASI: Eczema Area and Severity Index; EASI-75: 75% improvement in EASI; q2w: every 2weeks; qw: weekly.
Dupilumab SOLO 1 & 2: Proportion (%) of Patients Achieving EASI-75 at Week 16
6
Dupilumab SOLO 1 & 2: Percent (%) Change From Baseline to Week 16 in EASI Score
38
10
20
30
40
50
60
70
80
Pe
rce
nt
ch
an
ge
fro
m b
as
eli
ne
inE
AS
Is
co
re
SOLO 1
31
69
0
10
20
30
40
50
60
70
80
Pe
rce
nt
ch
an
ge
fro
mb
as
eli
ne
inE
AS
Is
co
re
SOLO 2
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
72* 72 *67*
*
0
Placebo Dupilumab 300 mg q2w Dupilumab 300 mg qw
* P<0.0001.EASI: Eczema Area and Severity Index; qw: weekly; q2w: every 2 weeks.
Dupilumab CHRONOS: Proportion (%) of Patients with IGA 0 or 1 and ≥ 2-point Reduction From Baseline at Week 52
36*40*
30
2012.5
10
0
40
50
Placebo + TCS Dupilumab 300 mg q2w + TCS
Dupilumab 300 mg qw +TCS
Pat
ient
sac
hiev
ing
IGA
1(%
)
* p<0.0001
IGA: investigator’s global assessment; q2w: every 2 weeks; qw: weekly; TCS: topical corticosteroid.
Source: Data on file
Dupilumab CHRONOS: Proportion (%) of Patients Achieving EASI-75 at Week 52
65* 64*60
40
2220
0
80
Placebo + TCS Dupilumab 300 mg q2w + TCS
Dupilumab 300 mg qw +TCS
Pat
ient
sac
hiev
ing
EA
SI-
75(%
)
* p<0.0001
EASI: eczema area and severity index; q2w: every 2 weeks; qw: weekly; TCS: topical corticosteroid.
Source: Data on file
7
Omalizumab treatment reduced mean weekly Itch Severity Scoreby Week 1
• Rapid-onset, dose-response, sustained efficacy at Wk 24 compared with Wk 12
Maurer M, et al. EADV 2013: FC09.1. Sponsored by Genentech, Inc. andNovartis
Mea
nch
ang
efr
om
b
asel
ine
0
–2
–4
–6
–8
–10
–120 4 8 12 16 36 40
Placebo Omalizumab 150 mg
Omalizumab 70 mg Omalizumab 300 mg
20 24 28 32Study week
4-weekly injections
All doses of omalizumab significantly reduced mean weekly ISS vsplacebo (primary endpoint)
–3.63
0-1-2-3-4-5-6-7-8-9
-10
PlaceboOmalizumab
75 mgOmalizumab
150 mgOmalizumab
300 mg
Mea
nch
ang
efr
om
bas
elin
ein
w
eekl
yIS
Sat
Wk
12
n=80 n=77 n=80 n=81
–6.46
p=0.0010
–6.66
p=0.0012
–9.40
p<0.0001
p values derived form t-test of least squares means of the differences between each of the omalizumab groups and placebo group using ANCOVA controlling for baseline weekly ISS (<13 vs ≥13) and baseline weight (<80 kg vs ≥80 kg). Baseline observation carried forward imputation was used for missing values
Maurer M, et al. EADV 2013: FC09.1. Sponsored by Genentech, Inc. andNovartis
Figur1e.Time to U1rt]car"a !Relapse·After 1Omallnz -1ab Tr1eatme1nt
U1, I - I
C :
' ! .;...._
12
10
8
a... 6
d;z 4
2
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D Clh1ronic sl)Jo int a1neous 11J1rtlicaria
Cok 11J1rtlicaria
II Clholinergic urticaria
D So d ri-urtica·ri-ia
D Symptomati( de·rmog1ra1p!h'ism
4 s 6 1 7
onths· eeks
Tiim1e1Before eappearanc1e1of Symptoms
E.ch patment is n p resent ed by a square. wl hcolors nd icating the type of urtik:anl.adisease. Two oalors with n a s nglesquare ndk:ate comorb1d t.yaf2.urticana dis, ea5es..
8
Inhibition of the hedgehog pathway inadvanced basal-cell carcinoma.Von Hoff DD et al.N Engl J Med. 2009;361(12):1164-72.
• 33 patients – metastatic or advanced BCC• GDC – 044a 16 partial and 2
complete responses• fatigue, hyponatremia, muscle spasm, afib
Randomized, double-blind study of sonidegib (LDE225) in patients with locally advanced or metastatic basal-cell carcinoma
J Clin Oncol 32:5s, 2014 (suppl; abstr 9009a^) MR Migden, etal
SONIDEGIB
Absorption Azelaic acid
Azelaic acid is most commonly formulated as a 20% cream, as a15% gel and a 15% foam. There is some published data absorption.Percutaneous absorption of azelaic acid into human skin from the
20% cream formulation is 3.6% of the dermally applied dose.[1]
The 15% gel formulation probably delivers higher amounts of azelaic acid to the skin, as studies on mice showed an 8-fold higher delivery (25.3% versus 3.4%) into viable skin for the gel than the creamWith both formulations the majority of the applied azelaic acid
1. Täuber U, Weiss C, Matthes H. Percutaneious absorption of azelaic acid in humans. Exp Dermatol. (1992)2. Draelos ZD. Noxious sensory perceptions in patients with mild to moderate rosacea treated with azelaic acid 15% gel. Cutis. 2004; 74(4):257-60.3. bbLi N, Wu X, Jia W, Zhanq MC, TanF, Zhang J. Effect of inoization and vehicle on skin absorption and penetration of AzelaicAcid.
9
Topical corticosteroid compounding: effects on physicochemical stability and skin penetration rate.Krochmal L, Wang JC, Patel B, Rodgers J.J Am Acad Dermatol. 1989; 21:979-84.
Salicylic acid
Camphor,menthol, phenolLCD
Desoximetasone alone Urea
Salicylic acid
10
Dependence of corticosteroid penetrationon the vehicle.Polano MK, Ponec M.Arch Dermatol. 1976; 112:675-80.
Topical steroid formulation selected to balance skinpenetration and retention, while minimizing percutaneous
30
Kircik L, et al. Poster presented at Winter Clinical, Koloa, Hawaii, Jan 15–20, 2016
• Test formulation F-10 demonstrated optimal penetration – permeation balance:High epidermal and dermal concentrations of betamethasone dipropionate with minimal receptor fluid levels
• Sernivo selected for further clinical development
absorption
Penetration of steroid into various skin layers
F-C= oleyl alcoholPermeation of steroid into retention fluid
11
31
DFD-01 HAD HIGHEST PENETRATION OF TOTAL BETAMETHASONES INTO THE EPIDERMIS AFTER 24 HOURS VERSUS OTHER COMMERCIAL
FORMULATIONS
Kircik L, et al. Poster presented at Winter Clinical, Koloa, Hawaii, Jan 15–20, 2016
32
REDUCTION IN TSS WITH DFD-01 WAS SIGNIFICANTLY GREATER THANAUGBD AT DAY 4 AND VEHICLE AT ALL TIME POINTS
Stein Gold L, et al. Poster presented at Winter Clinical, Koloa, Hawaii, Jan 15–20, 2016Pooled analysis
Supersaturation of calcipotriene and betamethasone dipropionate in a novel aerosol foam formulation for topical treatment of psoriasis provides enhanced bioavailability of the active ingredients.Lind M et al.
Dermatol Ther. 2016;6:413-25.
●rapid evaporation of solvents leaves the calcipotriene and BD in a supersaturated state●crystals form with other formulations of Cal/BD (ointment, topical suspension) but do not form after dispensing of the foam
(both Cal and BD, fully dissolved in the DME and butane solvents, do not form crystals
12
In vitro skin penetration data for BDP
0
2
4
6
8
10
12
%of
appl
ied
dose
Penetration of BDP (in CBD ointment and LEO 90100) into skin at different time points
14
Receptor fluid Applied skin
CBD ointment, 2h CBD ointment, 6h CBD ointment, 21h LEO 90100, 2h LEO 90100, 6h LEO 90100, 21h
In vitro skin penetration data for calcipotriol
0.0
10.0
20.0
30.0
40.0
50.0
60.0
70.0
80.0
%of
appl
ied
dose
Penetration of calcipotriol (in CBD ointment and LEO 90100) into skin at different time points
Receptor fluid Applied skin
CBD ointment, 6h
CBD ointment, 2h
CBD ointment, 21h
LEO 90100, 2h LEO 90100, 6h LEO 90100, 21h
Primary Response CriterionSubjects (%) with Controlled Disease by the IGA at Week 4
16 June,2017
p. 036
Full analysis set (LOCF)
54.6%
P=0.025
43.0%
Note: Graph illustrates observed values at each visit
13
Crisaborole Topical Ointment, 2%: A Nonsteroidal, Topical, Anti-Inflammatory Phosphodiesterase 4 Inhibitor in Clinical Development for the Treatment of Atopic Dermatitis.
Jarnagin K, Chanda S, Coronado D, Ciaravino V, Zane LT, Guttman-Yassky E, Lebwohl MG.
J Drugs Dermatol. 2016;15:390-6.
Primary Efficacy Endpoint: Percentage of Patients Achieving Success in ISGA (Clear [0] or Almost Clear [1] with ≥2-Grade Improvement From Baseline)
0
5
10
15
20
25
30
35
40
22 29*
%o
fP
atie
nts
Ach
ievi
ng
S
uc
ce
ss
(IS
GA
of
0o
r1
Wit
h≥
2-G
rad
eIm
pro
vem
ent)
15
Study Day
1 8
Crisaborole (AD-301; n = 503)
Crisaborole (AD-302; n = 513)
Vehicle (AD-301; n = 256)
Vehicle (AD-302; n = 250)
* Primary endpoints at Day 29: 301, p=0.038; 302, p<0.001
Crisaborole
Vehicle
Comparison of tofacitinib vs ETN or PBO in moderate to severe chronic plaquepsoriasis: Phase 3 RCT
Valenzuela F, et al. AAD 2014,
% patients achieving a PASI 75 responsethrough Week 12 (NRI)
PBO(N=107)Tofa 5 mg BID (N=329) Tofa 10 mg BID (N=330) ETN 50 mg BIW (N=335)
PA
SI7
5re
spo
nse
(%)
20
100
80
60
40
20
04 8 10 126
Week
5.6
63.6
58.8
39.5
% patients achieving a PGA response through Week 12 (NRI)
PG
A r
esp
on
se(S
E) 100
80
60
40
20
00 2 4 8 10 126
Week
15.0
68.266.347.1
% patients achieving a PASI 90 responsethrough Week 12 (NRI)
PA
SI9
0re
spo
nse
(%)
20
100
80
60
40
20
04 8 10 126
Week
36.132.221.0
0.9
14
Oral ruxolitinib induces hair regrowth in patients withmoderate-to-severe alopecia areata.Mackay-Wiggan J, et al. JCI Insight. 2016;1:e89790.
Safety and efficacy of the JAK inhibitor tofacitinib citrate in patients with alopecia areata Kennedy
Crispin M, et al.JCI Insight. 2016;1:e89776.
Reversal of Alopecia Areata Following Treatment With theJAK1/2 Inhibitor Baricitinib.Jabbari A, et al. EBioMedicine. 2015;2:351-5.
Tofacitinib Citrate for the Treatment of Vitiligo: A Pathogenesis-Directed Therapy.Craiglow BG, King BA.JAMA Dermatol. 2015;151:1110-2
Preliminary clinical activity of a topical JAK1/2inhibitor in the treatment of psoriasis.
Punwani N, et al.
J Am Acad Dermatol. 2012;67(4):658-64.
15
The efficacy of afamelanotide and narrowband UV-Bphototherapy for repigmentation of vitiligo.
Grimes PE, Hamzavi I, Lebwohl M, Ortonne JP, Lim HW.
JAMA Dermatol. 2013;149:68-73.
AAD Practice Management Center
Office of Access to Care and Treatment
Rachna Chaudhari
www.aad.org/priorauth
Prior Authorization Assistance Center
16
Prior Authorization Letter Tool
Prior Authorization Letter Tool
Prior Authorization Letter Tool
17
Prior Authorization Letter Tool
Prior Authorization Letter Tool
www.Parioar Adu.thoorrizgat/iopnrLieotterraTouotlh
1
Pediatric Dermatology PearlsCraig Burkhart, MD, MS
Pediatric Dermatology
The University of North Carolina at Chapel Hill
Male infant with coarse white hair and dark tips
Saggy, pudgy cheeks
Saggy, wrinkly skin
Pili torti
2
Menkes Disease
• X‐linked recessive neurodegenerative disorder
• Copper transporter mutation
• Copper depletion occurs after delivery
• Disease manifestations develop after 2‐3 months of age
• Hair reflects copper depletion over time
Hair that is distally darker
Blondeambitionblog.com
Saggy skin and floppy baby
http://escholarship.org/uc/item/85x9m8m1
3
Menkies Pearls
• Why the down face?
• History of copper dilution reflected in hair
Annular erythema in an 8 day old
Spongiosis, perivascular inflammation, no interface component: annular erythema of infancy (AEI)
4
Annular Erythema of Infancy
Annular erythema of infancy
Scaly
• Neonatal lupus until proven otherwise• ENA• Cardiology evaluation
Not‐scaly
• Consider autoinflammatorydisease (NOMID)• Articular disease• Neurologic disease• Fever• ESR, CRP, CBC• Ophthalmology evaluation
• Immunology evaluation
Neonatal lupus
FaceTelangiectasiasAtrophy
LupusImages.com
5
NOMID/CINCA Syndrome
Autoinflammatory‐search.org
www.AutoInflammatory‐Search.org
6
Annular Erythema in Neonates Pearls
• Always consider neonatal lupus and autoinflammatory disease
• Refer to cardiology if you have any suspicion for neonatal lupus• Even if biopsy and serologies are negative
• www.autoinflammatory‐search.org
7
Pearly white lesion on the left nipple
Nipple Bump Differential
Children
• Milia
• Milia‐like Syringoma
• Trichoepithelioma
• Fibroma
• Milia‐like Idiopathic Calcinosis Cutis
• Neonatal Fibroadnexal Polyp
Neonate
• Milia
• Neonatal Fiboradnexal Polyp
Neonatal Nipple Pearl
• Isolated pearly bumps on neonates will self‐resolve within a year
8
Bloody discharge in a 9‐year‐old boy
Worisome signs:‐ Unilateral‐ Persists longer than 9 months‐ Spontaneous discharge
Reassuring signs:‐ Centered on the nipple‐ Preadolescent
Biopsied after 10 months persistence
Mammary duct ectasia‐ brown‐colored mass with bloodstained fluid
9
Work‐up of discharge in infants and young children• Gram‐stain and culture of discharge
• Serum prolactin, estradiol, and thyrotropin
• Ultrasound of the affected breast
• If the above is normal and ultrasound consistent with mammary duct ectasia, consider a biopsy if the lesion lasts longer than 9 months
Kelly et al. Bloody Nipple Discharge in an Infant and a Proposed Diagnostic Approach. Pediatrics April 2006, volume 117(4)
Pediatric Nipple Discharge Pearls
• Work‐up of masses that last longer than 9 months
• Culture
• Ultrasound
• Pituitary work‐up (prolactin, TSH, estrodiol)
• Biopsy males if really needed
10
18 month old with a slow growing plaque
Pathology c/w dermatofibroma
Plaque‐like myofibroblastic tumor of infancy
• Appear in infancy and early childhood
• Lower back and hip
• Large plaque
• Histology similar to dermatofibroma
• Positive for factor XIIIa and SMA, negative for S‐100 and CD34
2 of 3 initially diagnosed as dermatofibromas by a great dermatopathologist
11
12
Plaque‐like Myofibroblastic Tumor Pearls
• Pathologist may diagnose as a dermatofibroma if you don’t provide with enough information
• Does not recur after excision
• Reassess diagnosis if it recurs after excision
‐ 8 Patients
‐ 6 days to 18 months after initiation of sennosides
‐ All bowel movements occurred overnight
‐ Chemical burn noticed during diaper change
13
Laxative‐associated contact dermatitis
• Only in non‐toilet‐trained children
• Prevent by giving Senna products at a time of day the allows for bowel movements to occur during the day (and not overnight)• 6‐10 hours after injestion
Irritant diaper dermatitis pearls
• Can clean feces with Vaseline soaked gauze instead of wipes
• Quantity of barrier cream (one‐half golf ball per diaper change) is more important than type of barrier cream
• Add an antifungal for any diaper dermatitis that lasts longer than 72 hours
14
‐ 7 month old with this eruption 3 month
‐ Started upon tapering tacrolimus
‐ Biopsy of neck revealed EPF
‐ Cleared with triamcinolone 0.1% ointm
‐ 8 yo boy with pruritic macules and papules 2 months after transplantation
‐ Biopsy c/w EPF
‐ Cleared with 5 months of betamethasone dipropionate ointment
15
Eosinophilic pustular folliculitis
• Recurrent crops/clusters of erythematous papules and pustules with an eosinophilic infiltrate on the biopsy
• Four types• Classic EPF• Immunosuppression/HIV‐associated EPF
• Infantile EPF• HSCT EPF
EPF‐HSCT
• Pruritic, follicular, erythematous papules and pustules
• Head, upper extremities, and trunk
• 2‐3 months after HSCT
• Resolves in several months
Infantile EPF
Hyper‐IgE Syndrome?
16
Burkhart Pearl: Bad red rashes in the first month of life are either:1. Ichthyosis2. Immunodeficiency3. Infection (candida or syphilis)
Consider an immunology workup for eczematous rashes that start in the 1st month of life. Don’t worry about infantile EPF.
Pediatric Eosinophilic Pustular Folliculitis Pearls• Treat symptomatically with steroids
• HSCT EPF resolves within months
• Infantile EPF resolves within years
• Base hyper‐IgE workup on timing of eruption and health of infant rather than EPF
1
DERMOSCOPY FORTHE NON‐DERMOSCOPIST
Kelly Nelson, MD FAAD
Associate Professor
Department of Dermatology
The University ofTexas
MDAnderson Cancer Center
Start Slow
Phase 1: Dermatoscope as amagnifying glass
• Get a dermatoscope
• Keep it in your pocket
• Look at everything before you biopsyit
Phase 2: test tumoridentification accuracy
• Commit on your pathology form• BCC vsSCC
• Melanocytic vs non‐melanocytic
• Do the introduction to dermoscopy course next year
Start Slow
Phase 3: Iterative learning
• Attend the advanced dermoscopy course
• Photographeverything
• Review your clinical impression, photographs and images
2
Data organization
• Organized folders• Year/Month/Clinic date
• Diagnosis spreadsheet
• Patient privacy/security
DermoscopyOverview
• Melanocytic: benign vsmalignant• Non‐melanocytic
• AK,SCC• BCC• SK
• Special sites• Facial• Acral
• Unknowns
Practical Use ofDermoscopy
• Ugly Duckling (clinical)
• Ugly Duckling (dermoscopic)
• Individual lesion (dermoscopic)• Pattern recognition
3
3 point check list
• Asymmetry
• AtypicalNetwork
• Blue‐white structures
Soyer et al. Three Point Checklist of Dermoscopy. Dermatology2004;208:27‐31
3 point checklistAverage Range
SensitivityOverall3‐point checklist
69.796.3
61.5 – 76.893.3 –98.0
SpecificityOverall3‐point checklist
82.832.8
77.0 – 87.420.7 – 47.7
Sensitivity: true positive rate;if the test is highly sensitive and it is negative, you can be nearly certain that they don’t have the condition;Sn(out)
Specificity: true negative rate;if the test is highly specific and it is positive, you can be nearly certain that they do have the condition;Sp(in)
3 point checklistAverage Range
SensitivityOverall3‐point checklist
69.796.3
61.5 – 76.893.3 –98.0
SpecificityOverall3‐point checklist
82.832.8
77.0 – 87.420.7 – 47.7
The three point check list helps you rule outmelanoma
If the three point check list is positive, it doesn’t mean that it certainly is melanoma; your clinical intuition is more reliable.
4
Pattern Recognition
•Reticular
• Globular
• Homogenous
•Organized
•Disorganized
Special Sites
• Facial• Asymmetrical pigmented openings
• Slate grey structures
• Acral• Furrows are fine
• Ridges are wrong
Schiffner et al. Improvement of early recognition of lentigo maligna using dermatoscopy. JAAD 2000 42(1):25‐32
5
Braun et al. The Furrow Ink Test. JAMA Derm 2008; 144(12):1618‐20; PMID19075144
Ink test: furrows are fine, ridges arewrong
Acral structure
Christa
intermediaEccrine
duct
Christa
limitans
Christa
intermedia
Stratum
corneum
epidermis
dermis
Fibrillar
Parallelfurrow
Lattice
J Am Acad Dermatol. 2005 Aug;53(2):230-6.
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Acral algorithm
Koga H, Saida T. Revised 3 step dermoscopic algorithm for the management of acral lesions. JAMA Derm2011;147(6):741
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