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Inicio Revista Médica del Hospital General de México A new siloxane embedded benzalkonium chloride-based skin protectant (fiteBac Ger...
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Vol. 81. Núm. 3.Julio - Septiembre 2018
Páginas 107-176
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Vol. 81. Núm. 3.Julio - Septiembre 2018
Páginas 107-176
Original Article
DOI: 10.1016/j.hgmx.2018.03.001
Open Access
A new siloxane embedded benzalkonium chloride-based skin protectant (fiteBac Germicidal Skin Softening Gel) for use against insect bites and related dermal infections
Una silicona nueva integrada con cloruro de benzalconio, para protección básica de la piel (fiteBac gel germicida suave para piel) para uso en picaduras de insectos e infecciones dérmicas relacionadas
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Gerhard R.F. Kruegera,
Autor para correspondencia
gerhard.krueger@uth.tmc.edu

Corresponding author.
, Dharam V. Ablashib, Babak Babanc, Clara Niedworokd
a Department of Pathology and Laboratory Medicine, UT-Houston Medical School, Houston, TX 77030, USA
b HHV-6 Foundation, Santa Barbara, CA, USA
c Departments of Oral Biology, Dental Surgery and Neurology, Medical College, University of Georgia, Augusta, GA 30912, USA
d Dental School, University of Duesseldorf, Germany
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Table 1. Clinical data base for GHS (germicidal hand softening) gel treatment.
Abstract

fiteBac Skin Softening Gel, widely used as a cosmetic, contains the anti-infective benzalkonium chloride embedded in siloxane quaternary ammonium compounds, but does not contain alcohol. It thus serves well for skin protection combined with local anti-infective activity. As it does not penetrate the skin, no systemic toxic side effects are expected, and more than 3 years of practical use have not revealed any adverse reactions.

We have tested in a pilot study the usefulness of fiteBac Skin Softening Gel against skin lesions following insect bites various in nature as well as a few other ailments (e.g. fungus-related intertrigo). Of the 23 cases tested, all but one responded to the treatment with complete resolution of skin lesions within a few days up to a week. The only exception was a case of suspected tick bite with local arthritic symptoms. In the latter, a combination of the fiteBac gel treatment with subsequent local administration of ibuprofen gel also resulted in complete remission of dermatitis and arthritis.

We thus recommend wider use of this cosmetic/anti-infective agent for the prevention and treatment of insect bites to prevent subsequent infectious complications (such as, for instance, Lyme disease).

Keywords:
Germicidal hand gel
Insect bites
Skin infections
Resumen

El gel fiteBac suave para piel, ha sido ampliamente empleado como cosmético, contiene cloruro de benzalconio y está integrado con compuestos de amoniaco cuaternario en silicona como anti-infeccioso, pero no contiene alcohol. Por lo tanto, sirve para la protección de la piel combinado con una actividad local anti-infecciosa. Como ésta no penetra la piel, no se esperan efectos secundarios, y en más de tres años de su aplicación no se han revelado reacciones adversas.

Se ha probado en un estudio piloto la utilidad del gel suavizante de piel en lesiones causadas por piquetes de insectos de diversa naturaleza, así como en otros padecimientos. (ej. micosis-relacionada con intertrigo). De 23 casos, todos menos uno respondió al tratamiento con la resolución total de las lesiones en la piel en unos cuantos días a una semana. La única excepción fue un caso con sospecha de mordedura de garrapata y síntomas de artritis local. Este último, la combinación del tratamiento con gel fiteBac y aplicación posterior de gel de ibuprofeno ayudó a la completa remisión de dermatitis y artritis.

Por lo anterior, se recomienda un uso más amplio de este agente cosmético/anti-infeccioso para la prevención y tratamiento de picaduras de insectos para evitar complicaciones infecciosas subsecuentes. (Como, por ejemplo, la enfermedad de Lyme).

Palabras clave:
Gel germicida para piel
Picaduras de insectos
Infecciones dermicas
Texto Completo
Introduction

Insect bites and stings may lead to transmission of pathogenic organisms and, in severe cases, are even treated as a medical emergency.1–4 Many of these are accompanied by secondary exanthema of various kind.5 Treatment commonly is done by epinephrine, diphenhydramine and steroids. Oral antibiotics may be given for infected bite wounds.6,7 Next step is to obtain a definitive diagnosis and to initiate appropriate treatments, for instance for such diseases as Lyme disease, West Nile fever, malaria, tularemia, plague, typhus and many others. Considering the world-wide presence of stinging and biting insects and the respective frequency of associated diseases, such conventional medical intervention affords a major effort in man-power and financial expenses. There are 30,000 cases of Lyme disease alone reported to the CDC annually (cdc.gov). Preventive measures for immediate treatment of such stings and bites, even by repellents to avoid such stinging insect would be a major advantage for general health care.

Common insect repellents recommended by CDC and EPA (cdc.gov; epa.gov) include DEET (N,N-diethyl-meta-toluamide), IR3535 ((3-[N-butyl-N-acetyl] aminopropionic acid, ethyl ester), Picaridin and a few others.6,7 Such substances, although effective as insect repellent, do not fight infections if a few bites have occurred despite of their use and thus transferred possible infections. It would be a major advantage, therefore, to have a substance which could combine both activities: insect repellent and anti-infectious actions.

We are presenting preliminary data of a study using a newly designed skin protectant cream which combines all three activities (skin protection, repellant, anti-infectious), and thus help to fight secondary infective diseases caused by biting and stinging insect.

Materials and methods

We used fiteBac Germicidal Hand Softening Gel (GHSG: Fig. 1, kindly provided by KHG fiteBac Technology, 3698 Largent Way, Marietta, GA 30064). The contents of the gel contain two cosmetics: an elastomer (cross linked silicon polymers) as found in lipsticks, antiperspirants, deodorants, and hair products. The second compound is a cosmetic ester PPG (Crodamol) also found in personal care products which combines to the elastomer to form a large polymeric organosilicon compound. The list of ingredient chemicals is as follows: Benzalkonium Chloride, Cyclopentasiloxane, Dimethicone Crosspolymer, PPG-3 Benzyl Ether Ethylhexanoate, Octadecyldimethyl Trimethoxysilylpropyl Ammonium Chloride. The anti-infectious activity of quaternary ammonium salts (QAS) and siloxanes is well documented from its use as polyurethane coating.8–12 The fiteBac Germicidal Hand Softening gel (GHSG), in laboratory testing, showed activities against various bacteria, and suggestive activities against several viruses and fungi (e.g. candida) (13,14[Molinari]) besides its skin cosmetic protectant activities.

Figure 1.
(0,08MB).

fiteBac Hand Sanitizer as Provided by KHG fiteBac Technology.

This pilot study for an initial screening of GHSG included 23 volunteers with various acute skin disorders (see Table 1), ages 12–81 years, 12 of which were males and 11 females. All consented to participate after respective risk information (“informed consent”).

Table 1.

Clinical data base for GHS (germicidal hand softening) gel treatment.

Patient (age/sex)  Diagnosis  Cause  Treatment  Result 
Mosquito bites
BK 79/F  Itching flare, edema, epidermal bullae  Chinese tiger mosquito Aedes albopictus (Fig. 2GHS for 5 days, one/day  Flare and edema for 2 days drying of bullae, complete resolution 1 week 
DA 44/M  Erythema, itching  Common mosquito Culex sp.  GHS for 2 days  Complete resolution 
MBK 81/F  Erythema, itching  Common mosquito Culex sp. (Fig. 3GHS for 3 days one/day  Complete resolution 
GRK 80/M  Erythema, itching  Common mosquito Culex sp.  GHS for 3 days one/day  Complete resolution 
KN 53/F  Edema, flare, itching  Unidentified mosquito  GHS for 5 days one/day  Complete resolution 
PF 12/M  Edema, itching, dermal blisters  Chinese tiger mosquito Aedes albopictus  GHS for 3 days twice/day  Complete resolution 
LMN 23/F  Flare, itching  Unidentified insect  GHS for 4 days one/day  Complete resolution 
KS 40/M  Mosquito bite prevention  Common mosquito Culex sp.  GHS to arms and legs one/day  Protection 
DV 18/M  Rash, edema, vesicles  Multiple unidentified mosquitoes  GHS to arms and legs one/day  Resolution in 3 days 
LN 22/F  Flare, nodule, itching arms and legs  Common mosquito Culex sp.  GHS for 2 days locally on lesions  Resolution 
Ticks and other
GK 78/M  Edema, erythema, nodule  Ixodes ricinus (Fig. 4GHS for 3 days twice/day  Flare resolved in 2 days nodule in 5 days 
CN 18/F  Erythema, itching  Unidentified tick  GHS for 6 days one/day  Resolution in 5 days 
MBK 79/F  Flare, itching, edema blisters  Spider bite (Fig. 5GHS for 5 days one/day  Resolution in 1 week 
Other skin infections
RBK 57/M  Edema, local arthritis (finger)  Suspected tick bite  GHS for 4 days ibuprofen creme  Edema, not pain resolution after 2nd week 
GRFK 80/M  Intertrigo  Suspected candida  GPS for 2 days  Resolution 
RK 56/M  Rapid growing skin papilloma  Suspected papilloma virus  GPS for 1 week twice/day  Shrinking and disappearance 
KA 68/F  Onychomycosis finger nails, eczema  Fungus (unidentified)  GHS for 2 weeks resolution  Resolution 
GK 78/M  Intertrigo  Suspected candida  GHS for 3 days  Resolution 
LN 21/F  Itchy rash, burning  Suspected neurodermitis GHS for 5 days  Resolution after reddening  Resolution after reddening 
CSN 51/F  “Dry and choppy hands”  Unidentified  GHS for 1 week  Smooth skin after initial flare 
GK 76/M  “Fast growing wart”  Suspected papilloma virus  GHS for 1 week  Wart drying in 4 days resolution in 1 week 
BP 75/F  Intertrigo inframammary crease  Unidentified  GHS for 3 days  Resolution 
RF 80/M  Intertrigo inguinal  Candida  GHS for 4 days then twice a week  Resolution 
Figure 2.
(0,09MB).

Aedes albopictus dermatitis and treatment effects. (a) Mosquito and acute vesicular dermatitis. (b and c) Drying of vesicles and disappearance of lesion after treatment with GHGS.

Figure 3.
(0,08MB).

Culex pipiens effects and treatment with GHS gel. Top: mosquito. (a–c) Acute and post-treatment lesion.

Figure 4.
(0,11MB).

Ixodes ricinus tick bites and treatment. Top and (a, b) tick and acute bite.

Figure 5.
(0,08MB).

European biting spider (suspected Wolf spider) and treatment. Top and (a) spider and acute lesion, (a and b) residual slight skin pigmentation after treatment. Lesion with exanthema migraines. (c) Treatment effects with GHSG.

The gel was administered to the skin immediately after bites of various insects with early symptoms occurring (reddening, edema, itching, bullous dermatitis). The course of local dermatitis was monitored by photography with follow-up for up to 3 years. Patients were interviewed for eventual late symptoms (fever, head ache, chronic exanthema, arthritis and others). Biting insects were identified – as far as possible – by inspection (see Table 1).

Results

All of the 23 cases but one treated with GHS gel reacted positively. Of these, 10 cases lead to complete resolution within 2–3 days. These included acute dermal reactions caused by the common mosquito Culex pipiens; a somewhat delayed reaction in lesions with dermal edema and blisters occurred in bites from the Chinese tiger mosquito, Aedes albopicta also named Stegomyia albopicta (3 days to 5 days). No additional bites were observed after the application of GHS gel for protection of uninvolved skin areas, and no side effects of the gel itself were recorded. One case with several mosquito bites and a 1 day delay in application of the gel afforded 5 days to completely resolve.

Excellent resolution within 2–3 days following GHS gel administration was found in four cases of intertrigo (intertriginous dermatitis, ID). ID develops in skin folds exposed to heat, moisture and friction (e.g. axilla, perineum, inframammary creases and others) and is commonly super-infected by candida organisms or bacteria. Conventional treatment is by drying agents, local antimicobial/antifungal drugs and occasionally topical steroid steroids (personal hygiene notwithstanding and testing for diabetes mellitus).

It took generally longer for complete resolution in cases with tick bites which included more severe local lesions such as blisters, nodular infiltrates, ulceration and – in one case – general exanthema. In such cases, at least one week of local GHS gel administration appeared advised.

Other cases which afforded longer (at least one week) administration included such not clearly identified cases as neurodermitis, certain “warts” (suspicious for papilloma virus infection), and “dry and choppy hands” (in the words of the patient). At least one week of treatment, if necessary longer, were required.

In one case, GHS gel was inefficient to resolve the problem: the patient had a suspected tick bite at the finger (not having identified the tick) with subsequent edema, swelling of the finger, and arthritic pain. After a week's treatment with GHS gel, only the additional application of a local anti-rheumatic ointment (ibuprofen) resulted in complete resolution after a second week.

Discussion

fiteBac Germicidal Hand Softening Gel (GHSG) is available as over-the-counter medication regulated and approved as non-prescription product defined in FDA's Topical Antimicrobial Monograph (RR Stewart, Senior Regulatory Consultant, Technology Science Advisory Group, Washington DC 20036, March 4, 2016). It serves as general skin cosmetic and protectant combined with antimicrobial (bacteria, viruses, certain fungi) activities.13,14 GHSG has several advantages over other preparations commonly used for similar indications. (1) It is a non-alcohol based hand sanitizer thus avoiding negative side effects of alcohols.15–17 It also avoids possible toxic effects of one of its ingredients (benzalkonium chloride) by its embedding in silicon polymers. It reduces resorption of the toxic ingredient significantly18 while protecting the skin and its local microenvironment.

Considering such advantages, we tested GHSG in a pilot study with 23 cases of dermatitis following various insect bites and related conditions. In all but one case, GHSG leads to complete remission of skin pathology caused by insect bites of various kind as well as in 4 cases of intertrigo (a candida- or bacteria-caused dermatitis). The only case in which GHSG was not sufficient was by a delayed application to a tick bite which already had caused arthritic complications. This case also resolved after addition of the anti-rheumatic ibuprofen. Our data thus warrant a greater use of GHSG for treating insect bites and some common dermatitis cases in the elderly.19 No toxic clinical effects were observed clinically during a 3 year period when used as a general cosmetic, and laboratory testing has shown that the gel does not penetrate the skin such as to initiate systemic toxicity.18

Our as well as other data referred to above warrant the tentative use of GHSG against skin infections by candida (e.g. in diabetics, and in babies such as diaper rash), by certain viruses (e.g. papilloma virus “warts” and herpes labialis/genitalis) and possibly to also alleviate the symptoms of shingles. Special targets for using the gel should include nursing homes for the elderly, boys scout- and military camps, as well as for travelers in subtropical and tropical countries.

Besides, GHS gel appears to be useful as insect repellent to avoid biting, and possibly also as general dermal antiseptic especially, as it is not an alcohol-based ointment and it avoids possible toxic side effects of resorbed benzalkonium chloride and common alcoholic preparations.

Funding

Local institutional funding.

Conflict of interest

No conflict of interest for any of the authors.

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