bionic solution management gmbh - kaiser solutions application20subjects.… · bionic solution...

Application test with BITE AWAY Questionnaire

bionic solution management GmbH 18 Fleischerstrasse 17489 Greifswald

Munster, 27 June 2005

Specialist dermatological report on

clinical-dermatological

APPLICATION OBSERVATION

in the case of insect bites (by midges and horseflies)

BITE AWAY Principal: bionic solution management GmbH

18 Fleischerstrasse 17489 Greifswald

Test persons: 20 subjects Test area: Lower leg Test period: Straightaway or hours after the insect bite up to fading away of symptoms

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Introduction Midges (Nemotacera) and flies (Brachycera) belong to the two-winged family of insects (Diptera). Midges of clinical importance are the various biting midges (Culicidae) and moth flies (Psychodidae) significant due to the transmission of leishmaniasis. Less common are bites from gnats (Simuliidae) and sandflies (Ceratopogonidae), two families capable of causing havoc in the vicinity of running water. Midges have long, thread-like, six-member antennae, thin bodies and normally long, thin legs. The larvae of midges demonstrate a varied lifestyle. They can live in water, on land or in food or bile. Feeding behaviour of the adult specimens is very also varied. This includes the juice from plants or blood (preferred by biting midges) and feeding is no longer possible if the mouthpiece has become atrophied. Biting midges (Nematocera) Midges have long, thread-like, six-member antennae, thin bodies and normally long, thin legs. The larvae of midges demonstrate a varied lifestyle. They can live in water, on land or in food or bile. Feeding behaviour of the adult specimens is also very varied. This includes the juice from plants or blood (preferred by biting midges) and feeding is no longer possible if the mouthpiece has become atrophied. The development of the reaction to the bite by biting midges depends on the sensitization by the host, which can change throughout the year and throughout life. Bites may take place without pain, a delayed papulous reaction to a bite that may last days indicates initial sensitization whereas combined immediate initial urticarial reactions followed by a delayed papulous reaction indicate advanced sensitization until these only give rise to an immediate urticarial reaction but/or lead to secondary tolerance. Sometimes, blisters the size of plumbs develop, normally on cyanotic lower legs. This Cullicosa bullosa was previously described unknowingly as the cause of Pemphigus hystericus. Indeed, reactions to bites to the lower leg by all other possible insect species can become bullous. Local or general allergic reactions over and above the normal reactions to bites are rare. In the tropics, various biting midges are of great clinical significance as the transmitters of feared diseases. For example, species of the genus Anopheles transmit malaria and filariasis, other biting midges transmit among others, yellow fever, dengue fever, pappatici fever, sleeping sickness and major epizootic diseases. Moth flies (Psychodidae) transmit leishmaniasis.

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Flies (Brachycera) Horseflies (Trabanidae) Flies have much more stockier bodies than midges, their antennae are much shorter and in three parts and they are more coloured than midges, often with a metallic shine. They feed differently as their mouths are shaped for licking or biting and sucking. Flies’ larvae are described as maggots and their heads and legs are set back. They live on land and sometimes also in water. Horseflies are among the commonest and best known of the biting Brachycera species in our part of the world and are noticeable by their bright flickering eyes. Their mouths are shaped like powerful stiletto-like wrenches. It is the relatively thick bristles that make the bite so painful. Feeding lasts several minutes if not disturbed. The main flying period for the blood-sucking females are warm and humid days. Many species can approach their hosts almost without sound. When biting, a secretion is injected to prevent the blood from clotting and which is responsible for the subsequent bleeding. Horseflies bite as soon as they land, which is normally felt as a slight stinging pain. There is always a reaction to the bite; there is no individual readiness to react. The bite is followed by an urticarial welt about 1 cm in diameter that will increase over a period of about 15 minutes. The individual species prefer various parts of the body: some species bite into the neck and head region, others in the arms, hands and upper legs. Horesflies, particularly in Africa cause harm to cattle. In the presence of large numbers, cattle, among others can lose up to 100 cm3 of blood a day. The constant contamination of the cattle leads to emaciation and a drop in milk output. Horseflies can also transmit Bacillus anthracis and Francisella tularensis.

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THE STUDY A total of 20 subjects took part in this study with insect bites (by horseflies and biting midges). They were first dermatologically tested; those with normal skin were included in the study. The subjects were instructed not to use any other preparations during the study. The products were handed out together with the use- and application instructions. The supervising dermatologist was able to carry out tests on skin conditions with objective and subjective skin changes. Questions were asked as to the subjective assessment criteria by way of a questionnaire at the end of the application period. The product for testing, Bite away was compared with Bite away kühl and Fenistil Gel, a bite remained untreated for test purposes. Each subject applied one of the products several times on an insect bite at the first signs of being bitten or on noticing a bite. The product used for the bite selected was chosen at random. Commencement in applying the preparations followed immediately in 16 cases and in four cases, hours after noticing an insect bite. The swelling was registered metrically on commencement of the application and 15 minutes after the first application. Itching sensations were felt on starting the application and 15 minutes after initial application. As itching is a completely subjective symptom, there is currently no standard procedure for establishing this. The quantification of this itching sensation by the subjects is based on a numerical six-point scale: 0: Significant increase in itching 1: Slight increase in itching 2: No change in itching 3: Slight decrease in itching 4: Significant decrease in itching 5: Itching stopped

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Subjects The test subjects consisted of male and female test persons with insect bites by horseflies and biting midges. Exclusion criteria - Serious or chronic skin conditions - Serious internal disorders with deterioration expected in the near future Dermatological tests 1. Prior to the application test

None of the 20 subjects showed any pathological skin changes.

2. During the application test 20 subjects showed intended reactions to insect bites in the area of the skin during the application. It was not necessary to interrupt the test or to carry out dermatological treatment.

3. At the end of the application test There were no undesired skin changes in the areas of the insect bites at the end of the final dermatological examination following the test and the subjects’ skin reacted very well to treatment with the product.

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DERMATOLOGICAL ASSESSMENT CRITERIA 1. Swelling SUBJECTIVE ASSESSMENT CRITERIA 1. Itching 2. Commencement of effect QUESTIONNAIRE AND EVALUATION OF TEST PRODUCT You have repeatedly applied and activated Bite away as appropriate immediately after (Question 1) or a few hours after (Question 3) noticing an insect bite. Please assess the process in comparison to the other products used for the treatment. In the case of use of Bite away, immediately after the insect bite: 1. Has there been any change to the itching by using Bite away?

Itching stopped x 7 Significantly reduced itching x 9 Slightly reduced itching x 0 No change in itching x 0 Slight increase in itching x 0 Significant increase in itching x 0

2. Time required before the product takes effect (please indicate point in time):

Straight away x 2 1–5 min. x 4 5 –10 min. x 3 10–15 min. x 7 Longer than 15 min. x 0 Longer than 30 min. x 0

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When using Bite away for a longer period (hours) after the insect bite: 3. Has there been any change to the itching by using Bite away?

Itching stopped x 2 Itching significantly reduced x 2 Itching slightly reduced x 0 No change in itching x 0 Itching slightly increased x 0 Itching significantly increased x 0

4. Time required before the product takes effect (please indicate point in time):

Straight away x 0 1–5 min. x 0 5 –10 min. x 2 10–15 min. x 2 Longer than 15 min. x 0 Longer than 30 min. x 0

After applying Bite away in general: 5. How do you assess the effectiveness of the preparation “Bite away” in general?

Very good (1) x 7 Good (2) x 12 Satisfactory (3) x 1 Satisfactory (4) x 0 Defective (5) x 0 Unsatisfactory (6) x 0

6. Was there any change in the itch following application of Bite away kühl?


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7. Was there any change in the itch following application of Fenistil?


8. How has the itch developed without any preparation?


9. Can you support the following statement as to the product’s effect? “By using “Bite away”, itching can be avoided or be reduced to insignificance.” [] I agree 20 [] I do not agree x 0 10. Can you support the following statement as to the product’s effect? “By using “Bite away”, swelling can be avoided or be reduced to insignificance.” [] I agree x 20 [] I do not agree x 0 11. Would you use “Bite away” again? [] Yes x 19 [] No x 1; Note: I do not treat my insect bites. 12. Would you also buy “Bite away?” [] Yes x 19 [] No x 1; Note: I do not treat my insect bites and would therefore not buy this product. Thank you very much for your cooperation.

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The following tables show the extent of swellings relating to 20 subjects measured on commencement and 15 minutes after applying the products. The values were established with respect to 20 subjects and the change in swelling after 15 minutes is shown per product. Change to the swelling after the bite, measured in cm, using Bite away Swelling in cm Subjects Start End Difference Percent Preparation 1 2,7 1,7 -1 -37,04 Bite away 2 3,1 2,2 -0,9 -29,03 Company: 3 2,9 1,8 -1,1 -37,93 bionic solutions 4 midge 0,5 0,3 -0,2 -40,00 5 1,5 0,5 -1 -66,67 Test duration: 15 minutes 6 hours 2,3 1,1 -1,2 -52,17 7 midge 0,8 0,3 -0,5 -62,50 8 2,8 1,6 -1,2 -42,86 9 hours 1,8 1 -0,8 -44,44 10 midge 0,7 0,4 -0,3 -42,86 11 3,5 2,9 -0,6 -17,14 12 2,9 1,8 -1,1 -37,93 Among “subjects” 13 2,3 1,6 -0,7 -30,43 No further details - 14 0,9 0,4 -0,5 -55,56 Horsefly bite 15 2,1 1,7 -0,4 -19,05 16 2 0,9 -1,1 -55,00 “Hours” application 17 hours 3,3 2,5 -0,8 -24,24 Hours after bite 18 hours 2,5 1,6 -0,9 -36,00 19 midge 0,4 0,2 -0,2 -50,00 20 midge 0,7 0,3 -0,4 -57,14 Average 1,99 1,24 -0,75 -41,90 Minimum 0,50 0,30 -1,20 -66,67 Maximum 3,10 2,20 -0,20 -17,14 Standard deviation 0,99 0,70 0,34 13,85 Variance 0,98 0,49 0,11 191,85 Change -41,90 Percent

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Change in the swelling in cm following the bite, after applying Bite away

Bite away

Sw

ellin

g in

cm

Subject

Bite away

Diff

eren

ce in

cm

Subjects

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Change in the swelling in % following the bite after using Bite away

Bite away

Per

cent

age

chan

ge

Subjects

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Change in the swelling in cm following the bite after applying Bite away kühl Swelling in cm Subjects Start End Difference Percent Preparation 1 2,9 2,4 -0,5 -17,24 Bite away kühl 2 3,3 3 -0,3 -9,09 Company: 3 2,5 2,3 -0,2 -8,00 bionic solutions 4 midge 0,6 0,4 -0,2 -33,33 5 1,7 1,2 -0,5 -29,41 Test duration: 15 minutes 6 hours 2,5 2,3 -0,2 -8,00 7 midge 0,6 0,4 -0,2 -33,33 8 3 2,6 -0,4 -13,33 9 hours 1,9 1,5 -0,4 -21,05 10 midge 0,8 0,4 -0,4 -50,00 11 3,3 2,9 -0,4 -12,12 12 2,7 2,3 -0,4 -14,81 Among “subjects” 13 2,2 1,9 -0,3 -13,64 No further details - 14 0,9 0,6 -0,3 -33,33 Horsefly bite 15 2,4 2 -0,4 -16,67 16 2,1 1 -1,1 -52,38 “Hours” application 17 hours 3,5 2,9 -0,6 -17,14 Hours after bite 18 hours 2,4 2 -0,4 -16,67 19 midge 0,7 0,5 -0,2 -28,57 20 midge 0,6 0,4 -0,2 -33,33 Average 2,03 1,65 -0,38 -23,07 Minimum 0,60 0,40 -1,10 -52,38 Maximum 3,30 3,00 -0,20 -8,00 Standard deviation 1,03 1,00 0,21 13,08 Variance 1,05 1,01 0,04 171,20 Change -23,07 Percent

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Change in the swelling in cm following the bite after applying Bite away kühl

Bite away kühl

Swel

ling

in c

m

Subject

Start finish

Bite away kühl

Diff

eren

ce in

cm

Subjects

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Change in the swelling in % following the bite after using Bite away kühl

Bite away kühl

Perc

enta

ge c

hang

e

Subjects

14


Change in the swelling in cm following the bite after applying Fenistil gel Swelling in cm Subjects Start End Difference Percent Preparation 1 2,6 2 -0,6 -23,08 Fenistil 2 3 2,8 -0,2 -6,67 Company: 3 2,9 2,5 -0,4 -13,79 bionic solutions 4 midge 0,7 0,6 -0,1 -14,29 5 1,3 1 -0,3 -23,08 Test duration: 15 minutes 6 hours 2,1 2,4 0,3 14,29 7 midge 0,5 0,5 0 0,00 8 2,6 2,8 0,2 7,69 9 hours 1,5 1,3 -0,2 -13,33 10 midge 0,5 0,5 0 0,00 11 3,3 3 -0,3 -9,09 12 2,6 2,4 -0,2 -7,69 Among “subjects” 13 2 2,2 0,2 10,00 No further details - 14 0,7 0,5 -0,2 -28,57 Horsefly bite 15 2,2 1,9 -0,3 -13,64 16 1,8 1,5 -0,3 -16,67 “Hours” application 17 hours 3,7 3,2 -0,5 -13,51 Hours after bite 18 hours 2,6 2,4 -0,2 -7,69 19 midge 0,6 0,6 0 0,00 20 midge 0,5 0,5 0 0,00 Average 1,89 1,73 -0,16 -7,96 Minimum 0,50 0,50 -0,60 -28,57 Maximum 3,00 2,80 0,30 14,29 Standard deviation 1,00 0,96 0,23 11,34 Variance 0,99 0,93 0,05 128,56 Change -7,69 Percent

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Change in the swelling in cm following the bite after using Fenistil gel

Fenistil

Swel

ling

in c

m

Subject

Fenistil

Diff

eren

ce in

cm

Subjects

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Change in the swelling in % following the bite after using Fenistil gel

Fensitil

Perc

enta

ge c

hang

e

Subjects

17


Change in the swelling in cm following the bite at untreated control Swelling in cm Subjects Start End Difference Percent Preparation 1 2,90 2,70 -0,20 -6,90 Untreated 2 3,20 3,10 -0,10 -3,13 3 3,10 3,00 -0,10 03,23 4 midge 0,60 0,60 0,00 0,00 5 1,40 1,40 0,00 0,00 Test duration: 15 minutes 6 hours 2,10 2,00 -0,10 -4,76 7 midge 0,70 0,70 0,00 0,00 8 2,90 2,90 0,00 0,00 9 hours 1,60 1,60 0,00 0,00 10 midge 0,90 0,90 0,00 0,00 11 3,50 3,40 -0,10 -2,86 12 2,70 2,70 0,00 0,00 Among “subjects” 13 2,40 2,40 0,00 0,00 No further details - 14 0,70 0,70 0,00 0,00 Horsefly bite 15 2,40 2,40 0,00 0,00 16 2,30 2,30 0,00 0,00 “Hours” application 17 hours 3,40 3,30 -0,10 -2,94 Hours after bite 18 hours 2,70 2,50 -0,20 -7,41 19 midge 0,60 0,60 0,00 0,00 20 midge 0,40 0,40 0,00 0,00 Average 2,03 1,98 -0,05 -1,56 Minimum 0,60 0,60 -0,20 -7,41 Maximum 3,20 3,10 0,00 0,00 Standard deviation 1,03 0,99 0,07 2,44 Variance 1,07 0,97 0,00 5,97 Change -1,56 Percent

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Change in the swelling in cm at untreated control following the bite

Untreated

Swel

ling

in c

m

Subject

Untreated

Diff

eren

ce in

cm

Subjects

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Change in the swelling in % at untreated control following the bite

Untreated

Perc

enta

ge c

hang

e

Subjects

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The following tables show the point values for the sensibility to itch with respect to 20 subjects given on commencement and 15 minutes after applying the products. The values were established for 20 subjects and the change in sensitivity after 15 minutes is shown for the products. The maximum value 6 means no more itch is present. In the evaluation, this value is shown as the itching having been stopped by 100%. Change in sensibility to itch following a bite when using Bite away

Bite away Subject No. Start 15 min. Difference Change in itch

in % 1 0 6 6 -100,00 2 1 5 4 -66,67 3 0 6 6 -100,00 4 midge 0 6 6 -100,00 5 1 5 4 -66,67 6 hours 1 5 4 -66,67 7 midge 1 5 4 -66,67 8 1 5 4 -66,67 9 hours 1 5 4 -66,67 10 midge 0 6 6 -100,00 11 1 5 4 -66,67 12 0 6 6 -100,00 13 1 5 4 -66,67 14 0 6 6 -100,00 15 0 6 6 -100,00 16 0 6 6 -100,00 17 hours 0 6 6 -100,00 18 hours 1 5 4 -66,67 19 midge 1 5 4 -66,67 20 midge 1 5 4 -66,67

Total 11 109 98 Average 0,55 5,45 4,9

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Change in itch after using Bite away

Abs

olut

e va

lue

Subjects

Change in itch after using Bite away

Val

ue in

%

Subjects

After 15 min.

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Change in sensibility to itch following bite after using Bite away kühl

Bite away kühl Subject No. Start 15 min. Difference Change in itch


Total 11 68 57 Average 0,55 3,4 2,85 -47,50

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Change in itch after using Bite away kühl

Abs

olut

e va

lue

Subjects

Start 15 min.

Change in itch after using

Bite away kühl

Val

ue in

%

Subjects

24


Change in sensibility to itch following bite after using Fenistil gel

Fenistil gel Subject No. Start 15 min. Difference Change in itch

in % 1 0 2 2 -33,33 2 1 4 3 -50,00 3 0 2 2 -33,33 4 midge 0 2 2 -33,33 5 1 3 2 -33,33 6 hours 1 3 2 -33,33 7 midge 1 3 2 -33,33 8 1 4 3 -50,00 9 hours 1 3 2 -33,33 10 midge 0 2 2 -33,33 11 1 3 2 -33,33 12 0 2 2 -33,33 13 1 3 2 -33,33 14 0 2 2 -33,33 15 0 2 2 -33,33 16 0 2 2 -33,33 0 0 2 2 -33,33 18 hours 1 2 1 -16,67 19 midge 1 2 1 -16,67 20 midge 1 2 1 -16,67

Total 11 50 39 Average 0,55 2,5 1,95 -32,50

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Change in itch after using Fenistil

Abs

olut

e va

lue

Subjects

Change in itch after using

Fenistil

Val

ue in

%

Subjects

26


Change in sensitivity to itch following the bite at untreated control

Control Subject Start 15 min. Difference Change in itch


Total 11 34 23 Average 0,55 1,7 1,15 -19,17

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Change in itch control

Abs

olut

e va

lue

Subjects

Change in itch

control

Val

ue in

%

Subjects

28


Comparison of the sensitivity to itch following the bite with respect to Bite away, Bite away kühl, Fenistil and the untreated control area

Comparison in the change in itching

Ave

rage

cha

nge

in %

Products

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ASSESSMENT OF TEST RESULTS

A total of 20 subjects successfully applied the stated preparation in the application test according to dermatological clinical criteria. There were no cases of undesired or even pathological skin changes in areas of the insect bites.

It can finally be said, from a dermatological standpoint and regarding this application study of 20 subjects that the product to be tested,

Bite away according to application under dermatological clinical criteria was endured very well and according to statements by subjects, the sensitivity to itching following insect bites was

reduced quicker and more significantly or stopped completely and swellings following bites by insects were also significantly reduced.

Dr Werner Voss Dr Gerrit Schlippe Consultant Dermatologist, Consultant Dermatologist, Venereologist and Allergologist Venereologist and Allergologist Specialist in Environmental Medicine Literature: Braun-Falco, Plewig, Wolff, Burgdorf, Landthaler (2005) Dermatology and venereology, Springer Medizin Verlag, Heidelberg

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