Title: FDA Experience: Topical Corticosteroids and HPA Axis Suppression
1Rx Topical Corticosteroids
HPA Axis Suppression and Cutaneous Effects
Denise Cook, M.D. Medical OfficerDivision of
Dermatology and Dental Drug Products
2OUTLINE
- Background
- Class Labeling for Topical Corticosteroids
- HPA Axis Suppression The FDA Experience
- Trial Data from Approved Drug Products
- Resultant Labeling Changes
- Postmarketing Summary
- Cutaneous Adverse Events from Topical
Corticosteroid Use
3Topical Corticosteroid Classification
- Seven Classes
- Class I Superpotent
- Class II High Potency
- Classes III, IV, V, VI Midpotency
- Class VII Low Potency
- Vasoconstrictor Assay
4Cosyntropin Stimulation Test
- Used to assess the function of the end organ -
the adrenal gland - in the hypothalamic-pituitary-
adrenal axis - In the case of topical corticosteroids, assessing
an exogenous unwanted treatment effect - Cosyntropin 0.125 mg or 0.25 mg is administered
IV at baseline and end of treatment - Blood is drawn for serum cortisol values at 30
minutes and sometimes 60 minutes post stimulation - Interpretation of the results determines a normal
or abnormal response
5Evolution of Interpretation of Normal Function
of the HPA Axis
- 1985
- am serum cortisol
- Urinary corticoid concentrations
- 1996 Cosyntropin Stimulation Test
- 30 minute post stimulation serum cortisol gt 20
µg/dL - If prestimulation serum cortisol 20 µg/dL, then
needed a 6ug/dL increment - 1999
- 30 minute post stimulation cortisol gt 18 µg/dL
6Evolution of Interpretation of Normal Function
of the HPA Axis
- 2001 - Cosyntropin Stimulation Test
- Control plasma cortisol level should exceed 5
µg/100mL - 30 minute level should show an increment of at
least - 7 µg/100mL
- 30 minute level should exceed 18 µg/100mL
- 2004
- 30 minute level should exceed 18 µg/100mL
7Class Labeling for Rx Topical Corticosteroids -
1990
- Effects on the HPA Axis
- Effects on Glucose Metabolism
- Development of Cushings Syndrome
- Effects on Growth
- Effects on Intracranial Pressure
8Two open-label trials withTemovateTM Ointment
- Trial 1
- 6 adult patients with psoriasis applied 7
grams/day to 30 BSA for 7 days - ACTH stimulation was performed at baseline and 2
post-treatment A.M. cortisols - 3/6 or 50 of patients exhibited decreases in
cortisol production
9Two open-label trials with TemovateTM Ointment
(contd)
- Trial 2
- Objective - determine the largest dose over a 7
day period that would not cause significant
suppression of the adrenal gland - 3 doses were used - 7 grams/day, 3.5 grams/day,
2.0 grams/day - Suppression was determined by A.M. plasma
cortisol levels and urinary corticoid
concentrations - None of the psoriatic patients suppressed at 7.0
grams/day or 3.5 grams/day but doses as low as
2.0 grams/day caused marked suppression of
cortisol secretion in patients with atopic
dermatitis.
10Temovate Label - 1985
- TEMOVATETM (clobetasol cream and ointment),
0.05, a Class I steroid - PRECAUTIONS General TEMOVATETM is a highly
potent topical corticosteroid that has been shown
to suppress the HPA axis at doses as low as 2 g
per day. - Pediatric Use Use of TEMOVATETM Cream and
Ointment in children under 12 years of age is
not recommended.
11Class Label Precautions Section
12- General Systemic absorption of topical
corticosteroids can produce reversible
hypothalamic-pituitary-adrenal (HPA) axis
suppression with the potential for gluco-
corticosteroid insufficiency after withdrawal
from treatment. Manifestations of Cushing's
syndrome, hyperglycemia, and glucosuria can also
be produced in some patients by systemic
absorption of topical corticosteroids while on
treatment.
13- Patients applying a potent topical steroid to a
large surface area or to areas under occlusion
should be evaluated periodically for evidence of
HPA axis suppression. This may be done by using
the ACTH stimulation, A.M. plasma cortisol, and
urinary free cortisol tests.
14- If HPA axis suppression is noted, an attempt
should be made to withdraw the drug, to reduce
the frequency of application, or to substitute a
less potent steroid. Recovery of HPA axis
function is generally prompt upon discontinuation
of topical corticosteroids. Infrequently, signs
and symptoms of glucocorticosteroid insufficiency
may occur requiring supplemental systemic
corticosteroids.
15- Class Label
- Pediatric Use Section
16- Safety and effectiveness in children and infants
have not been established. Because of a higher
ratio of skin surface area to body mass, children
are at a greater risk than adults of
HPA-axis-suppression when they are treated with
topical corticosteroids. They are therefore also
at greater risk of glucocorticosteroid
insufficiency after withdrawal of treatment and
of Cushing's syndrome while on treatment.
17- HPA axis suppression, Cushing's syndrome, linear
growth retardation, delayed weight gain, and
intracranial hypertension have been reported in
pediatric patients receiving topical
corticosteroids. Manifestations of adrenal
suppression in pediatric patients include low
plasma cortisol levels to an absence of response
to ACTH stimulation. Manifestations of
intracranial hypertension include bulging
fontanelles, headaches, and bilateral
papilledema.
18Topical Corticosteroid DataHPA Axis Suppression
- 10 drug products
- 8 topical corticosteroid products
- 2 topical combination drug products
- 11 studies
- Ages 3 months adult
- Open-label trials
- Cosyntropin stimulation test
19Topical Corticosteroid Drug Products
- Dermatop a mid potency steroid
- Cutivate Cream a mid potency steroid
- Diprolene AF Cream a high potency steroid
- Diprosone Ointment a high potency steroid
- Diprosone Cream a mid potency steroid
- Diprosone Lotion a mid potency steroid
- Clobex Lotion a super potent steroid
- Temovate E Cream a super potent steroid
20- Dermatop (prednicarbate emollient cream), 0.1
- a Class V steroid
- Approved May 1996
- Pediatric Atopic Dermatitis Trial
21- 59 pediatric patients enrolled
- 2 targeted populations
- - patients between 1 month and 2 years
- - patients between 2 and 12 years
- 10 patients were lt2 years old
- 49 patients were 2 years old
22Treatment Criteria
- gt20 body surface area (BSA) involvement
- Twice daily for 21 consecutive days
- ACTH Stimulation Test
- Cosyntropin administered at baseline and day 22
- Patients 15 kg received 0.25 mg IV
- Patients lt 15 kg received 0.125 mg IV
23Criteria per protocol for a normal adrenal
response to ACTH stimulation at 30 and 60 minutes
- Post stimulation serum cortisol gt20 µg/dL
- If pre-stimulation serum cortisol levels gt 20
µg/dL, an incremental increase gt6 µg/dL in serum
cortisol
24Three patients according to the protocol criteria
were suppressed 2 patients, 1 an 18 month old,
had a peak response of 5 µg/dL change from
baseline. 1 patient had a post-stimulation
cortisol value that decreased from baseline. At
that time, the Agency agreed with an outside
endocrinologist that since these 3 patients had a
post-stimulation response that was greater than
20 µg/dL, although they didn't have the required
incremental rise, they would not be
considered suppressed. This led to the current
label that reads that "none of the 59 patients
showed evidence of HPA axis suppression."
25 Cutivate (fluticasone) Cream, 0.05 a Class V
steroid Approved June 17, 1999 Pediatric Atopic
Dermatitis and Psoriasis Trial
26- 43 patients were evaluable ( all with moderate to
severe atopic dermatitis) - 29 patients 3 months to 2 years old
- 14 patients 3 years to 5 years old
27Treatment Criteria
- At least 35 BSA involvement
- Bid application for 3 - 4 weeks
- Patients up to 2 years limited to
- 120 grams/week
- Patients 3-5 years of age limited
- to 180 grams/week
28BSA Improvement Over Time(N46)
- 23 (50) had a decrease of 50 by 2 weeks
- 9 (20) had a decrease of 50 by 3 weeks
- 4 (9) had a 50 decrease by 4 weeks
29Cosyntropin Stimulation Test
- Test administered at baseline and
- end of treatment
- Younger age group given 0.125 mg cosyntropin IV
- Older age group given 0.25 mg cosyntropin IV
30Normal responseCosyntropin Stimulation Test
A serum cortisol level gt18 µg/dL at 30 minutes
post-stimulation
312 out of 43 patients experienced adrenal
suppression
Serum Cortisol (?g/dL) Serum Cortisol (?g/dL) Serum Cortisol (?g/dL) Serum Cortisol (?g/dL) Serum Cortisol (?g/dL) Serum Cortisol (?g/dL)
Baseline Baseline End-Tx End-Tx Follow-up Follow-up
Subject Age/Sex BSA Severity Duration Amt. Used Pre-stim Post-stim Pre-stim Post-stim Pre-stim Post-stim
B201 5 yrs/M 95 (95) 22 (9) 4 weeks 561.0 grams 22.1 33.9 7.1 11.8 2.1 19.8
B202 2 yrs/M 35 (35) 17 (7) 5 weeks 176.5 grams 10.8 28.6 2.1 9.4 LTF LTF
32Label Change for Cutivate Cream
- Indication Children as young as 3 months of age
for up to 4 weeks of use - Safety Update Information Precautions General
and Pediatric Use Sections
33Betamethasone Propionate - Approved in 2001
- Diprolene AF Cream, 0.05 - a Class II steroid
- Diprosone Ointment, 0.05 - a Class II steroid
- Diprosone Cream, 0.05 - a Class III steroid
- Diprosone Lotion, 0.05 - a Class V steroid
- Lotrisone Cream and Lotion (clotrimazole and
betamethasone propionate)
34Criteria for a Normal HPA Axis Response
- Follow the Cortrosyn label
- Failure of any one of 3 criteria would indicate
suppression of the HPA axis - Stimulation should occur at baseline and end of
treatment
35Criteria - 30 minute post-stimulation
- The control plasma cortisol level should exceed 5
µg/100 mL - The 30-minute level should show an increment of
at least 7 µg/100mL - above the basal level
- The 30-minute level should exceed
- 18 µg/100mL
36Diprolene AF Cream, 0.05
- 60 evaluable patients,
- ages 1-12 years with atopic dermatitis
- Mean BSA involvement - 58
- (range 35 - 95)
- Used study drug bid for 2 - 3 weeks
- Limited to 45 grams/week
37Diprolene AF Cream, 0.05 (contd)
- 19/60 or 32 of these patients showed evidence of
HPA axis suppression - 11/19 (58) had a post-stimulation plasma
cortisol value lt 18 µg/dL - 6/19 (32) failed to have an incremental change
of at least 7 µg/dL - 2/19 (11) had a pre-stimulation cortisol
- lt 5 µg/dL
38Suppression by Age Group
Age Group 3mo-1 yr n4 2yr-5yr n16 6yr-8yr n28 9yr-12yr n12
suppressed 2 6 9 2
50 38 32 17
- Recovery of normal HPA axis function
- 4 patients were retested 2 weeks post- treatment
and 3 of the 4 recovered normal function of the
HPA axis.
39Statistical Analysis in the Development of HPA
Axis Suppression
- No correlation between amount of drug used, body
weight, age or sex and the incidence of adrenal
gland suppression - Statistical relationship did exist between BSA
and risk of HPA axis suppression - for an increase of 1 BSA involved, risk of HPA
axis suppression increased 4.4 - p 0.01
40Label Change for Diprolene AF Cream, 0.05
- Indication - added an age restriction to 13 years
and older - Clinical Safety Information - Updated in the
Clinical Pharmacology, Precautions General and
Pediatric Use Sections
41Diprosone Ointment, 0.05
- 53 evaluable subjects with atopic dermatitis
- Age Range - 6 months to 12 years old
- Medication applied bid for 2 to 3 weeks
- Mean BSA Involvement - 58 (range
- 35 - 99)
42Diprosone Ointment, 0.05 (contd)
- 15/53 or 28 of patients showed evidence of HPA
axis suppression - 8/15 or 53 had a post-stimulation plasma
cortisol value lt 18 µg/dL - 7/15 or 47 failed to have an incremental change
of at least 7 µg/dL
43Suppression by Age Group
Age Group 3mo-1 yr n11 2yr-5yr n21 6yr-8yr n15 9yr-12yr n6
suppressed 4 6 4 1
36 29 27 17
44Statistical Analysis in the Development of HPA
Axis Suppression
- No statistically significant effect for
- Drug usage
- BSA
- Weight
- Age
- Higher proportion of males than females (p0.006)
who developed HPA axis suppression
45Recovery of HPA Axis FunctionDiprosone Ointment
- 2/15 patients were retested
- 100 recovery at 2 weeks
46Label Change Diprosone Ointment, 0.05
- Indication - added an age restriction to 13 years
and older - Clinical Safety Information - Updated in the
Clinical Pharmacology, Precautions, General and
Pediatric Use Sections
47Diprosone Cream, 0.05
- 43 evaluable patients with atopic dermatitis
- Age Range - 1 year to 12 years old
- Mean BSA Involvement - 40 (range
- 35 - 90)
- Medication applied bid for 2-3 weeks
48Diprosone Cream, 0.05 (contd)
- 10/43 or 23 of patients showed evidence of
adrenal suppression - 5/10 or 50 had a post-stimulation plasma
cortisol value lt 18 µg/dL - 3/10 or 30 failed to have an incremental change
of at least 7 µg/dL - 2/10 or 20 had a pre-stimulation cortisol
- lt 5 µg/dL
49HPA Axis Suppression by Age
Age Group 3mo-1yr n3 2yr-5yr n20 6yr-8yr n13 9yr-12yr n7
suppressed 0 6 3 1
0 30 23 14
50Statistical Analysis in the Development of HPA
Axis Suppression
- No statistically significant effect for
- Number of days treated
- Weight
- Age
- Statistical significance found for mean amount of
- drug used - 81 grams vs. 37 grams (plt0.001)
- There was a numerically higher BSA involvement
- Numerically, more males developed suppression
51Recovery of HPA Axis FunctionDiprosone Cream
- 2/10 patients were retested
- 1/2 (50) recovered HPA axis function at 2 weeks
52Label Change Diprosone Cream, 0.05
- Indication - added an age restriction to 13 years
and older - Clinical Safety Information - Updated in the
Clinical Pharmacology, Precautions, General and
Pediatric Use Sections
53Diprosone Lotion, 0.05
- 15 evaluable patients with atopic dermatitis
- Age Range - 6 to 12 years old
- Mean BSA Involvement - 45 (range
- 35 - 72)
- Medication applied bid for 2-3 weeks
54Diprosone Lotion, 0.05 (contd)
- 11/15 or 73 of patients showed evidence of HPA
axis suppression - 10/11 or 91 had a post-stimulation plasma
cortisol value lt 18 µg/dL - 1/11 or 9 failed to have an incremental change
of at least 7 µg/dL
55Suppression by Age Group
Age Group 3mo-1 yr n0 2yr-5yr n0 6yr-8yr n10 9yr-12yr n5
suppressed None enrolled None enrolled 7 4
- - 70 80
56Statistical Analysis in the Development of HPA
Axis Suppression
- Numerical analysis
- Subjects exhibiting HPA axis suppression
- Larger mean amount of drug used (92.8 g vs. 69.4
g) - Slightly higher BSA involved (45.8 vs. 41.8)
- Lower mean weights at visit 1 (65 lbs. vs. 81
lbs.) - Lower mean weights at visit 4 (65 lbs. vs. 80
lbs.) - Differences with respect to age and days of
treatment were miniscule -
57Recovery of HPA Axis FunctionDiprosone Lotion
- 6/11 patients were retested
- 4/6 (67) recovered HPA axis function at 2 weeks
58Label Change Diprosone Lotion, 0.05
- Indication added an age restriction to 13 years
and older - Clinical Safety Information Updated in the
Clinical Pharmacology, Precautions General and
Pediatric Use Sections
59Comparison of HPA Axis CriteriaBetamethasone
Dipropionate
60Lotrisone Cream
- Tinea Pedis Study
- Tinea Cruris Study
- Both studies were in the adolescent population
ages 12 16 years - Medication was applied twice daily
- Study duration
- 4 weeks for tinea pedis
- 2 weeks for tinea cruris
61Lotrisone Cream (contd)
- 17/43 (39.5) demonstrated adrenal suppression in
the tinea pedis study - 8/17 (47.1) demonstrated adrenal suppression in
the tinea cruris study
62Label ChangeLotrisone Cream and Lotion
- An Expanded Indications Section
- Added an age restriction patients 17 years and
older - Recommended that effective treatment may be
obtained without the use of a corticosteroid for
noninflammatory tinea infections - Updated Safety Information Precautions
General, Pediatric Use, Geriatric Use and Dosage
and Administration Sections
63- Clobex (clobetasol propionate), Lotion 0.05
- a Class I steroid
- Approved July 24, 2003
- Atopic Dermatitis and Psoriasis Trials
64Clobex Lotion
- 3 studies
- 2 adult studies one in psoriasis and one in
atopic dermatitis - 1 pediatric study (ages 12 17 years) in atopic
dermatitis - Comparator drug Temovate E Cream
- Class I steroid
- Same chemical moiety, clobetasol propionate
- Different vehicle, an emollient cream
65Construct of HPA Axis Evaluation
- The control plasma cortisol level should exceed 5
micrograms/100 mL - The 30 minute level should show an increment of
at least 7 micrograms/100 mL above basal level - The 30 minute level should exceed 18
micrograms/100 mL - Exceptions
- plasma cortisol levels were drawn at 60 minutes
post-stimulation. - In adult studies, subjects were stimulated with
cosyntropin weekly.
66Adolescent study
- 24 evaluable patients 14 treated with Clobex
Lotion and 10 treated with Temovate E Cream - Moderate to severe atopic dermatitis
- BSA treated at least 20
- Medication applied BID for 2 weeks
- 50 grams/week limit
67HPA axis suppression
- 9/14 (64) of subjects treated with Clobex Lotion
suppressed - 2/10 (20) of subjects treated with Temovate E
Cream suppressed
68Statistical Analysis
- Mean BSA treated was higher for patients with
adrenal suppression - 32.8 vs. 27.7 for Clobex Lotion
- 35 vs. 25.3 for Temovate E Cream
69Recovery of HPA Axis Function
- 1/4 of patients treated with Clobex Lotion
remained suppressed after 2 weeks - 1/1 patient retested after treatment with
Temovate E Cream recovered
70Adult Study
- 18 evaluable patients 9 treated with Clobex
Lotion and 9 treated with Temovate E Cream - Moderate to Severe Atopic Dermatitis
- Mean BSA treated 19.3 for Clobex Lotion and
19.4 for Temovate E Cream - Medication applied BID for 2 weeks
- 50 gram/week limit
71HPA Axis Suppression
- 5 / 9 (56) of subjects treated with Clobex
Lotion suppressed - 4 / 9 (44) of subjects treated with Temovate E
Cream suppressed
72Recovery of HPA Axis Function
- 1 / 3 patients on Clobex Lotion failed to recover
function 7 days post treatment - 2 /2 patients on Temovate E Cream recovered
function 7 days post treatment
73Adult Study
- 20 evaluable patients 10 treated with Clobex
lotion and 10 treated with Temovate E Cream - Moderate to Severe Plaque Psoriasis
- Mean BSA treated 16.2 for Clobex Lotion and
17.9 for Temovate E Cream - Medication applied BID for 4 weeks
- 50 gram/week limit
74HPA Axis Function
- 8 / 10 (80) of subjects treated with Clobex
Lotion suppressed - 3 / 10 (30) of subjects with Temovate E Cream
suppressed - 1 / 2 subjects with Clobex Lotion retested
remained suppressed after 8 days - 0 / 3 subjects on Temovate E Cream were retested
75Label for Clobex Lotion
- Indication restricted to patients 18 years or
older - 2 consecutive weeks not to exceed 50 grams (50 mL
or 1.75 fl. Oz) per week - Moderate or severe psoriasis, for localized
lesions lt 10 BSA can be treated an additional 2
weeks - Updated Safety Information Indications and
Usage, Precautions General and Pediatric Use,
and Dosage and Administration Sections
76- Postmarketing Summary
- HPA Axis Suppression
- Sources
- AERS Database
- Medical Literature Case Reports
77Adverse Event Reporting System(AERS)
- Spontaneous, voluntary surveillance system
- Voluntary reporting by health care professionals
and consumers - Mandatory reporting by manufacturers
- Approximately 3 million reports in database
- Database origin 1969
- Contains human drug and therapeutic biologic
reports exception vaccines (VAERS) - Quality of a report is variable and often
incomplete - Subject to under-reporting (true numerator not
known) - Duplicate reporting occurs
78Postmarketing SummaryHPA Axis Suppression
- 94 cases spanning 3 decades
- 65 adult cases
- 29 pediatric cases
- Manifestations
- Adrenal insufficiency
- Cushings Syndrome
- Growth Retardation
79Postmarketing ReportsPediatric Cases
- 29 pediatric patients
- 11 with adrenal insufficiency
- 17 with Cushings Syndrome
- 13 with Growth Retardation
- Characteristics
- Age range 6 weeks 15 years mean age 5.0 years
- duration of use 22 days 7.5 years mean use
20.8 months - 16 (55) received medication for 3 months or
longer - Varied indications but 34 used topical steroids
for diaper rash - Betamethasone containing, clobetasol, and
mometasone products implicated most often, with
34 using high potency topical steroids - Resulted in 14 hospitalizations and 2 deaths, the
latter from Cushings Syndrome
80Postmarketing ReportsAdult Cases
- 65 adult cases
- 46 with adrenal insufficiency/suppression
- 32 with Cushings Syndrome
- Characteristics
- Age range 19 years 74 years mean age 47.4
years - duration of use 7 days 12.0 years mean use
35.6 months - 30 (46) received medication for 3 months or
longer - Varied indications but 51 used topical steroids
for psoriasis - Betamethasone containing and clobetasol products
implicated most often, with 61 using high
potency topical corticosteroids - Resulted in 34 hospitalizations and 2 deaths
- Deaths attributed in part to the adrenal event
81Postmarketing ReportsCommon Factors in Adverse
Events
- Most AEs occurred in the setting of one or more
of the following - Prolonged use of topical corticosteroid
- Use of a super potent topical corticosteroid
- Use of multiple topical corticosteroid products
or concomitant use with other corticosteroid
formulations - Use of an excessive amount or possible
inappropriate use of the topical corticosteroid
product
82Summary HPA Axis Suppression
- HPA axis suppression does occur with the use of
topical corticosteroids - The adrenal suppression is not limited to the
super potent class of topical corticosteroids - High BSA involvement and amount of drug used
appear to be risk factors for HPA axis suppression
83Summary HPA Axis Suppression
- The type of vehicle may contribute to the extent
of absorption of the active chemical moiety - The suppression appears, in most cases, to be
reversible upon cessation of drug usage - Long-term use of topical corticosteroids,
particularly high potency ones, can lead to
serious morbidity and even death
84Cutaneous Safety
- Known cutaneous adverse events
- Question of cutaneous malignancy
85Cutaneous Safety
- Adverse Events associated with topical
corticosteroid use - Atrophy of the skin
- Telangiectasia
- Striae
- Erythema of the face
- Steroid Rosacea
- Hypopigmentation
- Infection
- Retarded Wound Healing
86Pictorial Presentationfrom University of
Erlangen Websiteand Bolognia Textbook of
Dermatology
87Atrophy
88Telangiectasia
89Striae
90Striae
91Facial Erythema
92Facial Erythema
93Steroid Rosacea
94Hypopigmentation
95Other Adverse Effects
- Topical corticosteroids placed on certain
infections, e.g. tinea infections, may exacerbate
them - Topical corticosteroids placed on open or
surgical wounds will retard healing - Use of topical corticosteroids in the periorbital
area may cause an increase in intraocular pressure
96Cutaneous Malignancy Postmarketing Reports
- 2 reports in AERS database as of February 5,
2005 US Cases - A 7 month old male with a history of mastocytoma
was diagnosed with skin cancer several months
after discontinuation of clobetasol - A female of unknown age used betametasone cream
for psoriasis and reported what started as
psoriasis became cancer - AERS data do not suggest a compelling safety
signal for malignancy formation with the use of
topical corticosteroids
97Cutaneous Adverse Events
- Corticosteroid induced AEs
- Can be an early or late event
- Depends on potency of drug and duration of use
- Depends on site of application
- Occlusion at the site may increase risk
- Corticosteroid induced AE
- May resolve slowly
- May not resolve
98Conclusion HPA Axis Suppression
- Can occur with short term use of topical
corticosteroids - Can occur with even mid-potency topical steroids
- Can occur as early as two continuous weeks of
therapy
99ConclusionHPA Axis Suppression
- Is usually reversible
- The interrelationship between BSA, amount of drug
used, and potency of medication is complex - Long term use and/or misuse of topical
corticosteroids, particularly those of high
potency, can lead to serious medical
complications and death
100ConclusionCutaneous Adverse Events
- Can be related to both duration of use and
potency of topical corticosteroid - Can occur with short-term or long-term use
- Resolution is possible with some but not all of
these cutaneous events - There is no firm evidence to date to link
cutaneous malignancy with use of topical
corticosteroids
101Rx Topical Corticosteroids
HPA Axis Suppression and Cutaneous Effects