Evaluation of the efficacy and safety of "Diaper Rash Cream" in the management of infantile irritant diaper dermatitis (IIDD)
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Evaluation of the efficacy and safety of
“Diaper Rash Cream” in the
management of infantile irritant diaper
dermatitis (IIDD)
SUKANTA CHATTERJEE, NILANJANA PRAMANICK, SANTA CHATTOPADHYAY, KINKOR MUNIAN,
KOLHAPURE S.A.
Abstract
Infantile irritant diaper dermatitis (IIDD) is an inflammation of the infantile skin covering the groin, lower stomach,
upper thighs and buttocks. Infantile irritant diaper dermatitis may become difficult to treat, if the area becomes
infected or the infant develops allergy to medications applied to the area. This study was conducted to evaluate the
efficacy and safety of “Diaper Rash Cream” in the management of IIDD.
The study was a prospective, phase III clinical trial, conducted as per the good clinical practice guidelines. A total
of 15 infants, who were suffering from IIDD, and whose parents were willing to give informed written consent were
included in the study.
At the initial visit, a detailed medical history was obtained by interviewing the parents regarding any dermatological
problem, or any adverse effect following the use of any baby product previously in the infant. Then, a detailed
physical examination of the infant was done including the dermatological system. Before beginning the study, the
“Diaper Rash Cream” was applied in a test dose and observed for the development of any immediate hypersensitivity
manifestations, for a period of 30 minutes. If there were no immediate hypersensitivity manifestations, the parents
were advised to apply the “Diaper Rash Cream” once daily, after bath for a period of 2 weeks, on the skin covering
the groin, lower stomach, upper thighs and buttocks. All the infants were followed up on the 7th and 14th day of
application, and at each follow-up visit, a detailed clinical examination was done. All the adverse events, either
reported or observed by the parents were recorded along with information about the onset, severity, duration and
site of the adverse reaction. The signs and symptoms of immediate skin irritation and delayed hypersensitivity
reactions were evaluated as per the standard reference guidelines.
There was a significant improvement in the clinical manifestations of IIDD in all the included infants, in 3 days,
and there was complete recovery from the clinical manifestations of IIDD, after a week’s application, in all the
included infants.
There was a significant reduction in itching in 10 babies, from the 3rd day onwards, and all the infants were relieved
of itching from the 5th day. There was also a significant reduction in 7 babies, with regard to erythematous scaly
diaper area, which often involves papulovesicular or bullous lesions, fissures, and erosions from the 3rd day onwards,
and all the infants were relieved of papulovesicular or bullous lesions, fissures, and erosions by the 6th day. Also,
there were no clinically significant adverse reactions, with excellent compliance.
The positive benefits observed in this study might be due to the synergistic action of the active ingredients of the
formulation viz. anti-inflammatory activities (of Aloe vera, Vitex negundo and Rubia cordifolia), antibacterial
activities (of Zinc calx, Aloe vera, Vitex negundo and Rubia cordifolia), wound healing activities (of Aloe vera),
and antioxidant activities (of Vitex negundo, Prunus amygdalus and Rubia cordifolia). Therefore, it can be concluded
that “Diaper Rash Cream” is effective and safe in the management of IIDD.
Dr. Sukanta Chatterjee
Professor & Head Introduction emollient delivering diapers, and
Dr. Nilanjana Pramanick
Diapers are used for the care of breathable diapers, and these newer
Dr. Santa Chattopadhyay types of diapers reduce the incidence
Dr. Kinkor Munian infants, young children and
Department of Pediatrics incontinent or paralyzed individuals, of diaper dermatitis. The non-
Medical College and Hospital,
to prevent fecal soiling and for social biodegradable material used in super
Kolkata, India
Dr. S.A. Kolhapure*, MD convenience. However, the use of absorbent diapers is, however, a
Senior Medical Advisor diaper poses a risk of developing matter of serious concern because of
R&D Center its toxic effects and environmental
The Himalaya Drug Company “irritant diaper dermatitis”, which is
Bangalore, India commonly known as “diaper rash”. pollution.1
*Corresponding author
Recent innovations in diaper Infantile irritant diaper dermatitis
technology have led to development is an inflammation of the infantile
Specially Contributed to "The Antiseptic"
Vol.102 No.5 & P : 251-255
of super absobent disposable diapers, skin covering the groin, lower
251 THE ANTISEPTIC May 2005stomach, upper thighs and buttocks. responsibilities, the importance of pruritus and urticaria – 0, very slight
Infantile irritant diaper dermatitis compliance, ethical aspects, and pruritus and urticaria – 1, well
may become difficult to treat, if the overall plan of the study. Informed defined pruritus and urticaria – 2,
area becomes infected or the infant consent was obtained in writing from moderate to severe pruritus and
develops allergy to medications the parents of all the included infants. urticaria – 3, and severe pruritus and
applied to the area. At the initial visit, a detailed urticaria – 4.
The “Diaper Rash Cream” is a medical history was obtained by The relation of adverse events to
polyherbal formulation recommended interviewing the parents regarding the study product was predefined as
for the prevention and treatment of any dermatological problem, or any “Unrelated” (a reaction that does
irritant diaper dermatitis, and adverse effect following the use of not follow a reasonable temporal
contains the powders of Zinc calx, any baby product previously in the sequence from the time of application
extract of Aloe vera and the oils of infant. Then, a detailed physical of the product and not localized to
Prunus amygdalus, Vitex negundo examination of the infant was done the whole site of application),
and Rubia cordifolia. This study was including the dermatological system. “Probable” (follows a known
conducted to evaluate the efficacy Before beginning the study, the responsible pattern to the suspected
and safety of “Diaper Rash Cream” “Diaper Rash Cream” (Batch No.: product, but could have been
in the management of IIDD. 40601-RD) was applied in a test dose produced by the baby’s clinical state
and localized at the site of
Aim of the study and observed for the development of
any immediate hypersensitivity application), “possible” (follows a
This study was planned to known responsible pattern to the
manifestations, for a period of 30
evaluate the clinical efficacy and suspected product that could not be
minutes. If there were no immediate
safety (short- and long-term) of reasonably explained by the known
hypersensitivity manifestations, the
“Diaper Rash Cream” in the mana- characteristics of the baby’s clinical
parents were advised to apply the
gement of IIDD. state and localized at the site of
“Diaper Rash Cream” once daily,
Study design after bath for a period of 2 weeks, on application).
The study was a prospective, the skin covering the groin, lower Results
phase III clinical trial, conducted at stomach, upper thighs and buttocks.
There was a significant impro-
the Well Baby Clinic, at the All the infants were followed up vement in the clinical manifestations
Department of Pediatrics, Medical on the 7 th and 14th day of application, of IIDD in all the included infants,
College and Hospital, Kolkata, from and at each follow-up visit, a detailed in 3 days and there was complete
September to December 2004, as per clinical examination was done. The recovery from the clinical mani-
the good clinical practice guidelines. parents were advised to discontinue festations of IIDD, after a week’s
the product, if they noticed any application, in all the included
Methods and materials
adverse effect. infants.
Inclusion and exclusion criteria
Adverse events There was a significant reduction
A total of 15 infants, who were in itching in 10 babies, from the 3rd
suffering from IIDD, who were born All the adverse events, either
reported or observed by the parents day onwards, and all the infants were
at term, with a birth weight of more relived of itching from the 5th day.
than 2500 grams (having appropriate were recorded along with information
about the onset, severity, duration There was also a significant reduction
gain in weight, length, and head in 7 babies, with regard to
circumference, and a normal psycho- and site of the adverse reaction. The
signs and symptoms of immediate erythematous scaly diaper area, which
motor development on pediatric often involves papulovesicular or
physical examination), and whose skin irritation and delayed hyper-
sensitivity reactions were evaluated bullous lesions, fissures, and erosions
parents were willing to give informed from the 3rd day onwards, and all the
written consent were included in the as per the standard reference
guidelines. The scoring scales for infants were relieved of papulo-
study. Infants who were under some vesicular or bullous lesions, fissures,
medication for systemic or topical various adverse effects were as
follows: Scoring scale for evaluating and erosions by the 6 th day. Also,
disease, and those babies, whose there were no clinically significant
parents were unwilling to give written erythema: no erythema – 0, very
slight erythema – 1, well defined adverse reactions, with excellent
informed consent before entering the compliance.
study, were excluded from the study. erythema – 2, moderate to severe
erythema – 3, and very severe There were no clinically
Study procedure erythema – 4. Scoring scale for significant adverse reactions (either
The parents who brought their evaluating edema: no edema – 0, reported by the parents or observed
infants for routine check up at the very slight edema – 1, slight edema by the investigators) during the entire
Well Baby Clinic were informed – 2, moderate edema – 3, and severe study period. There were no dropouts,
about the study product, its effects, edema – 4. Scoring scale for and the overall compliance to the
duration of study period, their evaluating pruritus and urticaria: nil product use was excellent.
May 2005 THE ANTISEPTIC 252Discussion C. zeylanoides. Other organisms results revealed that, exposure to the
Infantile irritant diaper dermatitis, present in the mixed culture from the formulations directly on adult skin
a frequent condition, is a form of diaper area were Staphylococcus prior to an irritant challenge was
contact dermatitis, occurs due to the aureus, Escherichia coli, and few associated with significant reduction
interaction of multiple factors strains of streptococci (groups B and in skin barrier damage and skin
(increased wetness, elevated local D), and Proteus mirabilis. Infants erythema, and greatest reductions
skin pH, fecal enzymes and diapered exclusively in disposable were seen for the zinc containing
microorganisms), and manifests as diapers showed less rash than those formulations. Wearing of the
an erythematous rash. Increased diapered exclusively or sometimes in formulation treated diaper was also
wetness in the diaper area makes the cloth diapers.5 associated with a significant
skin more susceptible to damage by reduction in skin erythema and diaper
The principle of treatment of rash compared to the control
physical, chemical, and enzymatic
diaper dermatitis is to keep the skin product.9
mechanisms. Wet skin increases the
in the nappy area as dry as possible
penetration of irritant substances. The with frequent nappy change, and The principle constituents of Aloe
urease enzyme found in the stratum barbadensis are anthraquinones
absorbent disposable diapers are
corneum liberates ammonia from (aloe-emodin and aloin A (barbalin),10
known to reduce the incidence of
cutaneous bacteria, which has an diaper dermatitis. Absorbent dis- cinnamoyl, p-coumaroyl, feruloyl,
irritant effect on nonintact skin. caffeoyl aloesin, aloemannan, 11
posable diapers do not allow urine to
Lipases and proteases in feces mix acemannan, verectin,12 elgonica dimer
come into contact with the skin, and
with urine on nonintact skin and can hold large amounts of urine. For A and bisbenzopyran.11 Aloe vera has
cause an alkaline surface pH, adding anti-inflammatory, antifungal,
all practical purposes these diapers
to the irritation. (Feces in breastfed immunosuppressive, and wound
only need to be changed when they
infants have a lower pH, and become soiled with feces or they get healing properties. The active
breastfed infants are less susceptible ingredients of Aloe vera have been
so heavy that they are down near the
to diaper dermatitis.) The bile salts found to exhibit immunosuppressive,
child’s ankles. 6
in the stools enhance the activity of anti-inflammatory activities,
fecal enzymes, adding to the effect.2,3 This study observed complete bradykinin degrading and cell
recovery from IIDD in all the proliferation-stimulating activities.12
Candida albicans has been Ali et al. found that anthraquinones
included babies, after a week’s
identified as a contributing factor to application. Also, there were no from Aloe vera are responsible for
diaper dermatitis, and the infection the antifungal activity. 13 The
clinically significant adverse
often occurs after 48-72 hours of constituents of Aloe barbadensis have
reactions, with excellent compliance.
active eruption. Candida albicans has The positive benefits observed in this wound healing properties. 14,15 Davis
been isolated from the perineal area et al. evaluated the extracts of Aloe
study might be due to the synergistic
in as many as 92% of children with vera for topical anti-inflammatory
action of the active ingredients of
diaper dermatitis. Other microbial the formulation. activity, and the results showed that
agents have been isolated less small amounts of Aloe vera given
frequently, perhaps more as a result Zinc has been widely used in the topically inhibit inflammation
of secondary infections. In a clinical treatment of diaper dermatitis and induced by a moderate amount of
study, Ferrazzini et al. investigated various studies have demonstrated irritant.16 Another study by the same
the relevance of Candida sp. and the antibacterial efficacy of zinc author demonstrated the antioxidant
Staphylococcus aureus colonization oxide. Collipp et al. observed and anti-inflammatory effects of
in IIDD and determined the significant reduction in the incidence aloesin derivative (isorabaichromone)
correlation between the extent of of diaper rash, with oral zinc in Aloe vera. As Aloe vera has long
colonization and the severity of supplementation.7 In another study, been used to promote wound healing,
disease. The results showed a Collipp et al. noted that IIDD was the inhibitory effects of aloesin
significant, positive correlation associated with reduced hair zinc, derivatives for cyclooxygenase
between severity of disease and and infants with the least hair had (Cox)-2 and thromboxane (TXA 2)
extent of Candida spp. colonization lower zinc levels than infants with synthase were examined and the
at all swab locations (the colonization the most hair. 8 Baldwin et al. participation of p-coumaroyl and
by Staphylococcus aureus was conducted a study to determine the feruloyl ester groups in the aloesin
nonsignificant).4 In a study by Dorko clinical benefits of a novel disposable skeleton was demonstrated, which
et al. the occurrence of Candida spp. diaper designed to deliver a zinc explain, the wound healing effects of
was determined in infants, with diaper oxide and petrolatum-based Aloe vera. 17 Bautista-Perez et al.
dermatitis, and the most frequently formulation continuously to the skin demonstrated the antibradykinin
isolated species was Candida during use. They evaluated the effect and hence anti-inflammatory
albicans, followed by C. prevention of skin irritation and activities of Aloe vera. 18 In a study
parapsilosis, C. tropicalis, C. barrier damage from a standard skin by Vazquez et al. the aqueous extract
pulcherrima, C. guilliermondii, and irritant in an adult arm model. The of Aloe vera gel inhibited
253 THE ANTISEPTIC May 2005prostaglandin E2 production from Conclusion 71(10): 907-908.
arachidonic acid. The chemical tests Infantile irritant diaper dermatitis 2. Ather ton DJ. A review of the
performed on the aqueous extract for is an inflammation of the infantile pathophysiology, prevention and
anthraglycosides, reductor sugars and skin covering the groin, lower treatment of irritant diaper dermatitis.
cardiotonic glycosides were stomach, upper thighs and buttocks. Curr. Med. Res. Opin . 2004; 20(5):
positive.19 Infantile irritant diaper dermatitis 645-649.
Prunus amygdalus is a rich source may become difficult to treat, if the 3. Flagothier C, Pierard-Franchimont C,
of antioxidants (tocopherols, squalene area becomes infected or the infant Pierard GE. How I explore ... diaper
and phytosterols).20 Kayano et al. develops allergy to medications dermatitis. Rev. Med. Liege . 2004;
documented high antioxidant applied to the area. This study was 59(2): 106-109.
activities of Prunus amygdalus.21 conducted to evaluate the efficacy 4. Ferrazzini G, Kaiser RR, Hirsig Cheng
The principle ingredients of Vitex and safety of “Diaper Rash Cream” SK, Wehrli M, Della Casa V, Pohlig G
negundo are flavone vitexcarpin,22 in the management of IIDD. et al. Microbiological aspects of diaper
dermatitis. Dermatol . 2003; 206(2):
negundins A and B, diasyringaresinol, There was a significant impro- 136-141.
lyoniresinol, vitrofolal E and F,23 6- vement in the clinical manifestations
phenyldihydronaphthalene-type of IIDD in all the included infants, 5. Dorko E, Viragova S, Pilipcinec E,
lignan, vitedoin A, phenyl- in 3 days and there was complete Tkacikova L. Candida—agent of the
naphthalene-type lignan alkaloid, recovery from the clinical diaper dermatitis? Folia. Microbiol.
(Praha) 2003; 48(3): 385-388.
vitedoamine A, and trinorlabdane- manifestations of IIDD, after a week’s
type diterpene, and vitedoin.24 Vitex application, in all the included 6. Prasad HR, Srivastava P, Verma KK.
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antibacterial activity of Vitex negundo and erosions by the 6 th day. Also, administration of a zinc oxide/
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The principal constituents of The positive benefits observed in
Rubia cordifolia are purpurin, this study might be due to the 10.ElSohly MA, Gul W, Murphy TP.
munjistin, purpuroxanthin, pseudo- Analysis of the anthraquinones aloe-
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purpurin and rubiadin, 28,29 ingredients of the formulation viz.
anthraquinones (cordifoliol and chromatography/mass spectrometry.
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38.
Functional Somatic Syndromes are illnesses The Australian government is proposing that
characterized by symptoms that, as yet, have no clear by mid 2005 every packet of cigarettes and
pathophysiology. These include chronic fatigue tobacco sold there will feature graphic images
syndrome, fibromyalgia, Gulf War illness, irritable bowel of smoking related diseases over half the front
syndrome, and premenstrual dysphoria. Although the and rear panels.
clinical manifestations of these illnesses are not
The proposals warnings covering half each
identical, they have in common increased sensitivity to
pack in January 2001, and Brazil, which
pain, sleep disturbances, difficulty with concentration,
introduced similar images in February 2002.
and labile mood.
(NEJM – December 23, 2004) (BMJ – May 2004)
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