D/O N.V.PRATAPA REDDY,
D.NO.2-7A-7/1,VENKATNAGAR,
KAKINADA,ANDHRA PRADESH-533003.
2 / NAME OF THE INSTITUTE / S. S. INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
DAVANAGERE-577005
KARNATAKA
3 / COURSE OF STUDY
AND SUBJECT / POST GRADUATE DEGREE
M D DERMATOLOGY,VENEREOLOGY AND LEPROLOGY
4 / DATE OF ADMISSION TO THE COLLEGE / 10TH JUNE 2013
5 / TITLE OF THE TOPIC / STUDY OF CONTACT DERMATITIS TO COSMETICS,WEARING APPAREL & JEWELLERY BY PATCH TESTING
RAJIVGANDHIUNIVERSITY OF HEALTH SCIENCES,BANGALORE
KARNATAKA
ANNEXURE II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION
6 / BRIEF RESUME OF INTENDED WORK
6.1 NEED FOR THE STUDY
Contact dermatitis is an inflammatory response of the skin to an exogenous substance(irritant and/allergen).
It may be classified as follows:
1.Irritant contact dermatitis
2.Allergic contact dermatitis
3.Photocontact,phototoxic dermatitis
4.Immediate contact reactions
5.Non-eczematous reactions.1
Allergic contact dermatitis is an immunological reaction that occurs in genetically susceptible people who have been previously sensitized to an allergen.This is in contrast to Irritant contact dermatitis which can occur in any person if the amount and duration of irritant exposure are sufficient to cause direct epidermal keratinocyte damage.Contact dermatitis is a common problem encountered in dermatology clinics.Ofall contact dermatitis 80percent are caused by irritant contact dermatitis and 20 percent are caused by allergic contact dermatitis.2
CONTACT DERMATITIS TO COSMETICS:
Nowadays almost everyone is using cosmetic products,which includes cleansing products such as soaps,bath and shower products,shampoos and toothpaste,as well as, for example deodorants andmake up products.Indeed they are used to clean,perfume,change the appearance, protect from body odours,and protect and keep the skin,teeth, and mucosal membranes in good condition.3
Allergic reactions to cosmetic products are increasingly observed.The cosmetic allergens involved can reach the skin in several different ways; by direct application,by occasional contact with an allergen-contaminated surface, by airbornecontact (e.g.,vapours or droplets), by transfer by the hands to more sensitive areas (e.g.,the eyelids) by a product used by the partner (or any other person) or be photo induced,resulting from contact with a photo-allergen and exposure to sunlight, particularly UV-A light.3
CONTACT DERMATITIS TO WEARING APPARELJEWELLERY
Nickel allergy is a common problem to which human beings are continously exposed, be it at home,work place or hospitals.Nickel sensitivity is common in the general population with a prevalence rate of 4-13.1% and is on the increase.Nickel is an important constituent of artificial jewellery,clothing,materials like metal zips,bra hooks,suspender clips,personal articles like watches,lipstick holder,knives etc.,and household utilities like kitchen utensils,machinery parts.Safety pin,due to its nickel content and ubiquitous usage across India, has proved to be a major cause of worry for its potential impact on most women across India.4
Sensitization to nickel is the main cause of metal-induced allergic contact dermatitis.However,other metals including cobalt(Co),chromium (Cr),palladium(Pd)and gold(Au),are also known to cause ACD.5
PATCH TESTING:
Epicutaneous patch testing is the gold standard method for the diagnosis of allergic contact dermatitis. More than 3000 chemicals are known to cause ACD. Certainly patch testing 3000 chemicals is not practical. Thankfully a small percentage of these 3000 chemicals account for a large percentage of cases of ACD.Knowledge of the most commonly implicated allergens and a thoughtful patient history including personal care products,occupation,and hobbies can guide appropriate allergen selection for patch testing.2
Hence the present study is taken up to know the incidence of contact dermatitis due to cosmetics,wearing apparel and jewellery and to study the value of patch testing in these cases.
6.2 REVIEW OF LITERATURE
The term ‘allergie’ was first coined by the scientist von Pirquet in 1906. Allergic sensitization of the skin was first proved experimentallyby Bloch and Steiner-Woerlich using primulaextract on humans.6
Patch testing is the diagnostic tool for allergic dermatitis and itis Josef Jadassohn who is generally accepted as the founder of thistechnique in 1895 while working at Breslau University, publicationtaking place the following year.6
Bruno Bloch was a dermatological pioneer who was able toexpand and enhance Jadassohn’s technique while working inBasel in 1911, when he also produced a grading system for patchtestreactions. He then moved to Zurich where he introducedthe concept of a standard series of allergens.6
According to study conducted by SanjeevHanda,Rashmi Jindal of560 patients of suspected allergic contact dermatitis over a 6 year period 303(54.1%) were males and 257(45.9%) were females with age ranging from 9 to 85 years. Nickel sulphate (17.5%) was the most common sensitizing agent in females followed by potassium dichromate(7%), fragrance mix(7%) and mercaptobenzothiazole(6.2%).In males, potassium dichromate(16.8%) was the most common allergen and next in frequency were nickel sulphate(7.26%),fragrance mix(7.26%),and cobalt chloride(6.9%).7
The standard series ofhaptens used for patch testing commonly includes,among 25-30 of the mostprevalenthaptens,the metal ions Ni,Co andCr.In subjects with metal ACD,e.g.,jewellery reactors,reactivity with Ni is the most prevalentfollowed by reactivity with Co,Pd, Au and Cr(e.g.94.5%,34%, 17%,10% and3% respectively).It is common that the patients are sensitized to multiple metal ions, whether this is due to concurrent sensitization, cross reactivity or in some cases,both is not fully understood.However, several studies have suggested that sensitization to one metal ion increases the chance of being sensitized to other metals.5
The study included 31 patients with a history of eczematous reactions typical of ACD and positive patch test to metals and five healthy volunteers with no history of ACD and negative patch test.Sixteen patients were tested with a standard series(Ni,Co andCr)while the remaining patients and the controls were also patch tested with Au and Pd.Many patients displayed reactivity with multiple metals,most commonly between Ni and Co.5
A retrospective study was conducted among 10,335 female patientswith dermatitis patch tested between 1985 and 2007 to examine whether Danish nickel regulation has reduced the prevalence of nickel allergy and to examine whether the prevalence of cobalt allergy has increased as a result of the nickel regulation.Nickel allergy decreased among young female patients whereas it increased among older patients.The prevalence of cobalt allergy remained relatively unchanged.8
A studywas conducted on 50 patients with foot eczema, who attended the out-patient department. The patch test was performed using Indian standard series. Patch test was positive in 88% of the patients. The most common site affected was the dorsal aspect of the foot (48%) and scaly plaque was the predominant morphological pattern. The highest number of patients (24%) showed positive reactions to mercaptobenzothiazole (MBT) and the lowest (4%) to neomycin sulfate. Rubber and rubber chemicals have been reported worldwide to be the most common sensitizer causing foot eczema.9
A delayed hypersensitivity type of allergic contactdermatitis was observed following exposure to certainbrands of 50% cotton, 50% polyester coloredpermanent-pressed sheets produced by a particular manufacturer in 200 patients who when patch tested with their own sheet gave a charactersticeczematous reaction.10
A study was conducted on 3120 patients with 49 allergens. Of these patients, 66.5% had positive allergic patch test reactions, and 57% had at least one allergic reaction that was felt to be clinically relevant to the present or past dermatitis. The 12 most frequent contact allergens were nickel sulfate, fragrance mix, thiomersal, quaternium-15, neomycin sulfate, formaldehyde, bacitracin, thiuram mix, balsam of Peru, cobalt chloride, para-phenylenediamine, and carba mix.11
A study was conducted on 4,913 patients with 65 allergens. The top 10 allergens remain the same in this study period as in the 1999-2000 study period; nickel sulfate (16.7%), neomycin (11.6%), Myroxilonpereirae (balsam of Peru) (11.6%), fragrance mix (10.4%), thiomersal (10.2%), sodium gold thiosulfate (10.2%), quaternium-15 (9.3%), formaldehyde (8.4%), bacitracin (7.9%), and cobalt chloride (7.4%).12
6.3 OBJECTIVES OF THE STUDY
1.To know the clinical patternof allergic contact dermatitis to cosmetics, wearing appareljewellery.
2.To evaluate the incidence of allergic contact dermatitis due to commonly used cosmetics, wearing apparel, jewellery by patch testing
7 / MATERIALS AND METHODS
7.1 SOURCE OF DATA
The study group will be drawn from patients attending the Outpatient department of Dermatology,Venereology and Leprology at SS Hospital,attached to SS Institute of Medical SciencesResearch Centre,Davangere for a period of 15-18 months from Dec 2013- June 2015.
7.2 METHOD OF COLLECTION OF DATA
A study group of about 100 patients with clinical features suggestive of contact dermatitis to cosmetics, wearing apparel,jewellery belonging to both sexes between age group of 9-85yrs will be included in the study after taking their consent.7Patch testing will be done on the back / arm of the patient with the finished commercial product being used by the patient and the antigens of the Indian Standard Series and Cosmetic series kit. The standard patch test reading will be taken after 48hrs. The patch test reaction is graded as follows.
GRADE / STRUCTURE / EVALUATION
? / Faint macular erythema / Doubtful reaction
+ / Erythema,infiltration,discrete papules / Weak (non-vescicular)
allergic reaction
++ / Erythema, infiltration, papules,
vesicles / Strong(Vesicular) allergic reaction
+++ / Intense erythema, infiltration,
coalescing vesicles, bullous or
ulcerative / Extreme allergic reaction
- / No / Negative
IR / Variable / Irritant reaction
NT / No / Not tested
In all cases necessary investigations will be done.
a)INCLUSION CRITERIA
1. Patients with onset of dermatitis following use or during use of a certain kind of cosmetic,wearing apparel orjewellery and recurrence/persistence of the same by its or further use.
2. Patients with dermatitis involving the affected areas conforming to the pattern of different varieties of cosmetics,wearing apparel and jewellery.
3. Patients willing for patch testing and follow up.
b)EXCLUSION CRITERIA
1. Other cutaneous disease clinically at the time of presentation as for example,a mechanical irritant dermatitis,fungal infections,atopic dermatitis
2. Patient on immunosuppressive therapy
3. Acute stage of dermatitis (these patients will be patch tested after the acute manifestations subside)
4. Pregnancy
STATISTICAL ANALYSIS:
Data will be presented in terms of number and percentage with tables and graphs
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS? IF SO PLEASE DESCRIBE BRIEFLY.
Yes,the following investigations are required:
1.Complete hemogram
2.Patch testing
3.Skin scraping for fungus (if necessary)
4.RBS (if necessary)
5.AEC (if necessary)
7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION FOR THE ABOVE?
Obtained
8 / LIST OF REFERENCES
- Bajaj.A.K,SaraswatAbir.ContactDermatitis.In:Valia.R.G,Valia.A.R,editors. IADVL Textbook of Dermatology. 3rd ed. Vol.1.Bhalani;2012,p.545-46.
- Nelson.J.L, Mowad Christen.Allergic Contact Dermatitis.J ClinAesthe Dermatol2010;3(10): 36–41.
- Goossens An. Contact-Allergic Reactions to Cosmetics.J Allergy .2011;11: 467-71.
- Vandana Mehta, VaniVasanth,Balachandran.C.Nickel contact dermatitis from hypodermic needles.Indian J Dermatol. 2011; 56(2): 237–38.
- Minang.J.T,Arestrom.I, Troye-Blomberg.M, Lundeberg L,Ahlborg.N. Nickel, cobalt, chromium, palladium and gold induce a mixed Th1- and Th2-type cytokine response in vitro in subjects with contact allergy to the respective metals.ClinExpImmunol. 2006; 146(3): 417–26.
- Beck.M.HWilkinson.S.M.Contact Dermatitis: Allergic.In: Burns T,Breathnach S,Cox N,Griffiths C,editors.Rook’s Textbook of Dermatology. 8th ed.Vol.2.West Sussex:Wiley-Blackwell;2010.p.26.1-2.
- SanjeevHanda,Rashmi Jindal.Patch Test results from a contact dermatitis clinic in north india. Indian J Dermatol,Venereol Leprol. 2011; 77: 128-32.
- Thyssen.J.P, et al.Prevalence of nickel and cobalt allergy among female patients with dermatitis before and after Danish government regulation:a 23 year retrospective study.J Am AcadDermatol. 2009;61-5.
- Priya,et al.Foot eczema: The role of patch test in determining the causative agent using standard series. Indian J Dermatol. 2008; 53(2): 68–9
- Francois Panaccio, MontgomeryD.C and AdamJ.E. Follicular contact dermatitis due to coloured permanent-pressed sheets. Can Med Assoc J. 1973; 109(1): 23–6.
- James G. Marks Jr,et al.North American Contact Dermatitis Group patch test results for the detection of delayed-type hypersensitivity to topical allergens.J Am AcadDermatol. 1998;38: 911–8.
- Pratt MD,et.al.North American Contact Dermatitis Group patch-test results, 2001-2002 study period.Dermatitis. 2004 ;15(4):176-83
9 / SIGNATURE OF THE CANDIDATE
10 / REMARKS OF THE GUIDE / The present study is undertaken for better understanding of contact dermatitis due to cosmetics,wearing apparel and jewellery
11 / NAME AND DESIGNATION OF: (IN BLOCK LETTERS)
11.1 GUIDE / DR.JAGANNATH KUMAR.V
PROFESSOR & HEAD OF THE DEPARTMENT
DEPARTMENT OF DERMATOLOGY
SSIMS&RC
DAVANGERE
11.2 SIGNATURE
11.3 CO-GUIDE
11.4 SIGNATURE
11.5 HEAD OF THE
DEPARTMENT / Dr. JAGANNATH KUMAR.V
PROFESSOR & HEAD OF DEPARTMENT
DEPARTMENT OF DERMATOLOGY
S.S INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE,
DAVANGERE- 577005
11.6 SIGNATURE
12 / 12.1REMARKS OF THE
CHAIRMAN AND PRINCIPAL
12.2 SIGNATURE
1