Patch testing to Propylene glycol: The Mayo

Clinic experience
Dr. Soogan Lalla, Dr. H. Nguyen, Dr. H. Chaudhry, Dr. L. Drage, Dr. J Yiannias,
Dr. M. Hall, Dr. M. Davis
Department of Dermatology
Mayo Clinic, Rochester, MN

American Contact Dermatitis Society, San Diego

02/15/2018
©2017 MFMER | slide-1
Background

• Vehicle, solvent and humectant

• Increasing use in skin care products and topical medicaments
• Skin Safe® database - 41% of 27,323 products contain PG or modified
PG
• Contact dermatitis to moisturizers and ECG electrode gels containing PG
reported as a case series in 1978*

* Fisher A, Propylene Glycol Dermatitis .Cutis 1978 Feb; 21 (2): 166, 170, 174-8
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 Aims

To report the Mayo Clinic experience: patient demographics,

prevalence and trends of positive patch test reactions to
Propylene Glycol from 1997 – 2016.

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 Propylene Glycol patch test
concentrations
Mayo clinic allergen series
1997 – 1999 5% and 10% Aq form
2000 – 2009 10% PG
2009 – 2016 20% in water
Standard, pediatric, gynecology, machinist, oral flavors & preservatives
North American Contact Dermatitis Group
1992 – 10% PG in standard series
1996 – 30% PG
2013 – 30% & 100% PG

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Methods
• Retrospective series review

• Electronic patch test database (Sybase) used for data collection from RST,
ARZ, FL sites

• Patch test applications were performed in accordance with NACDG

recommended methods

• 1st reading at 48-72 hrs, 2nd reading at 96-108 hrs

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 Methods:Patch test readings
Reaction Description
macular erythema

weak (non-vesicular erythema, infiltration,

or papules)
strong (erythema with edema and
vesicles)
extreme (spreading, bullous, or ulcerative
lesions)

Mayo Clinic, ©2017 MFMER | slide-6

Methods: Patch test readings
Reaction Description

weak

strong

extreme

Weak, strong, extreme reactions were counted as positive

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Results
• 11,738 patients underwent 12 021 patch test applications between 1997 –
2016.

• positive patch test rate 0.85% (100 /11738)

• Irritancy rate 0.35% ( 41 / 11738)

Reaction grade n (%)

Papular erythema Weak + 87 (87.0)
Erythema with edema / vesicles Strong ++ 9 (9.0)
Bullous reaction extreme +++ 4 (4.0)

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Demographics: all patients patch tested
Mean (SD) age: 54.2 (18.0) y
Sex: 7,802 (66.5%) female
Rochester site: 7492 (63.8%) Arizona: 3107 (26.5%) Florida: 1139 (9.7%)
Race: white: 9,836 (83.8 %)
Atopy* 3171 / 8418 (37.7%)

Dermatitis site* generalized (24.8%)

hand (21.1%)
face (15.4%)
arm (13.8%)
other (24.4%)

*Recorded from 2003 onwards, n= 8148 unknown / unrecorded (8.5%)

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 Demographics: all patients patch
tested Allergic dermatitis
Final diagnosis* (40%)
Dermatitis, NOS
(32.1%)
Other (17.8%)

Atopic dermatitis
(8.6%)
Unknown /
unrecorded (8.5%)
Irritant dermatitis
*Recorded from 2003 onwards, n= 8148 (5.6%)
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 Demographics: PG positive patients
Mean (SD) age: 55.5 y (16.3)
Sex: 53 (53.0%) female
Race: white:87 (87.0%)
Atopy: 44/100 (44%)
dermatitis site* Generalized 36.7%
Hand (18.9%)
Arm (17.8%)
Leg (14.4%)
Other
Unknown (5.6%)
* Recorded from 2003 onwards, n= 90
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 Demographics: PG positive patients

Final diagnosis* Allergic Occupation*

unknown
dermatitis (44.4%)
(57.8%)
Dermatitis, retired
NOS (21.1%)
(33.3%)
Atopic Child <18 y
dermatitis (4.4%)
(6.7%)
Other (8.9%) Nurse
/nurses aide
(3.3%)

* Recorded from 2003 onwards, n= 90 ©2017 MFMER | slide-12

Propylene glycol test results
1997 - 2016
4
3.5
3
2.5 2.2
2
positive (%)
1.5
irritant (%)
1 0.8
0.4 0.4 0.4 0.5
0.5 0.2 0.2
0
1997 -2001 2002 -2006 2007 -2011 2012 - 2017
(N = 2352) (N = 3575) (N - 2967) (N = 2664) Corchan-Armitage trend
test, p < 0.001

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Propylene glycol test results
1997 - 2016
4
3.5
3
2.5 2.2
2
positive (%)
1.5
irritant (%)
1 0.8
0.4 0.4 0.4 0.5
0.5 0.2 0.2
0
1997 -2001 2002 -2006 2007 -2011 2012 - 2017
(N = 2352) (N = 3575) (N - 2967) (N = 2664) Corchan-Armitage trend
test, p < 0.001
10% 20% PG as test
allergen ©2017 MFMER | slide-14
 Summary of findings

• PG positive patients more likely to be atopic. Age, sex, ethnic origin,

dermatitis sites, and final diagnosis profiles are otherwise similar to all
patients patch tested.
• Significant increase in positive patch test rate between 1997-2001, and
2011 – 2016 time periods 0.4% 2.2%
• 10% PG concentration increased to 20% in 2009 – likely direct cause

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 Study strengths & limitations
• Large dataset - 11 738 patients over a 20 year period.
• Uniform training of dermatology physicians ensures consistency of patch
test readings.
• Clinical relevance could not be confirmed in some patients.
• There is a higher rate of atopy and dermatitis in study population compared
with the general population
• Concentrations used at Mayo clinic and the NACDG core allergen series
differ so no statistical comparability is possible between the 2 groups.

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Conclusions
• Contact sensitivity results to Propylene glycol has increased at
Mayo Clinic over a 20 year period, likely due to an increase in
test allergen concentration used.

• We recommend that the allergen is retained in the standard

series.

• Further studies are required to determine the optimal PG

concentration used for patch testing.

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Extra slide

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 Summary of findings

• PG positive patients more likely to be atopic. Age, sex, ethnic origin,

dermatitis sites, and final diagnosis profiles are otherwise similar to all
patients patch tested.
• Significant increase in positive patch test rate between 1997-2001, and
2011 – 2016 time periods 0.4% 2.2%
• Smaller increase in irritancy rate 0.2% 0.5%
• 10% PG concentration increased to 20% in 2009 – likely direct cause

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