Flamozil. Gentle wound treatment
A novel, cooling wound care gel in a convenient pressurised cannister that combines the best of known practice, i.e. a carbomer hydrogel for dry and exsudating wounds, with novel ingredients:
- Flamozil is delivered in a pressurised canister with easy one-hand operation (a lot of people burn their right hand)
- Flamozil is entirely without parabens
- Flamozil is preserved by a patented silver dihydrogen citrate complex
- Unlike other woundcare hydrogels, Flamozil is not neutralized with arginine or NaOH. Instead the intrinsic skin factor L-carnosine is used to stabilize the gel
Free of parabens
Parabens are obviously excellent preservatives. However, dermatologists are becoming increasingly aware of the potential adverse effects of parabens (alkyl esters of 4-hydroxybenzoic acids) on skin. Methylparaben potentiates UV-induced damage of skin keratinocytes (1), decreases the proliferating ability of keratinocytes and changes the cell morphology in vitro (2). Parabens also decrease the expression of hyaluronan synthase 1 and 2 and type IV collagen and affect the epidermal differentiation of the skin (2). Long-chained parabens such as (iso)-butylparaben may contribute to estrogenic effects in skin as a result of inhibition of skin estrogen sulfotransferase activity (3,4). Following these concerns the Scientific Committee on Consumer Products (SCCP) of the EU has issued several reports trying to balance the issue and ended with a request to industry for more trial data (5).
At Oystershell we believe that especially in wound care, where the skin barrier is no longer intact, it is best to avoid parabens.
1. Handa et al. 2006. Methylparaben potentiates UV-induced damage of skin keratinocytes. Toxicology 227:62-72
2. Ishiwatari et al. 2007. Effects of methyl paraben on skin keratinocytes. J Appl Toxicol. Jan-Feb: 27(1).
3. Prusakiewicz et al. 2007. Parabens inhibit human skin estrogen sulfotransferase activity: Possible link to paraben estrogenic effects. Toxicology 232: 248-256
4. Soni et al. 2005. Food and Chemical Toxicology 43: 985-1015
5. SCCP. 2005. Extended opinion on the safety evaluation of parabens. SCCP/0873/05
Silver (dihydrogen) citrate, a smart alternative for parabens in wound care products
Silver dihydrogen citrate is an electrolytically generated source of stabilized ionic silver that is aqueous, colorless, odorless and non-irritating with a long shelf life. Silver citrate preserves the formulation by two modes of action: 1) the silver ion deactivates structural and metabolic membrane proteins leading to microbial death; 2) the microorganisms view the citrate as a food source and internalize it, thus allowing the silver ion to enter as well. Once inside the organism, the silver ion denatures DNA, which halts the microorganisms' ability to replicate, leading to its death. This dual action makes silver citrate a highly and quickly effective alternative.
Oystershell has evaluated the antimicrobial activity of Flamozil according to the Eur. Ph. V.5.1.3.
The results show a reduction of more than 5 log units in two days, even a very low concentration. It is therefore expected that Flamozil, while not an antimicrobial treatment per se, will be excellently protected against micro-organisms.
Non-irritating and non-stinging
Based on the EPA toxicity categorization of antimicrobial products that ranges from Category I (high toxicity) down to Category IV, Silver citrate, at the used concentration, is rated in the lowest toxicity category (IV) while most traditional disinfectants fall into Categories I and II.
Application of Flamozil on abraded rabbit skin (test according to ISO10993-2002) revealed no irritation (Primary irritation index of 0.0). Also, in 3-day, occlusion patch tests on human volunteers, including a subpopulation of atopic dermatitis patients no irritation was found (6).
6. 30 subjects (17 F, 13 M), 12 of whom with an atopic history, and/or 20 with a contact allergy to one or more of the allergens tested (cfr. Table), were tested epicutaneously from October 22nd 2007 until November 27th 2007, in the Contact Allergy Unit of the Department of Dermatology (University Hospital, Katholieke Universiteit Leuven) with the product mentioned above.
Closer to the biology of the skin
Hydrogel carbomers are acidic and are generally neutralized with arginine or (caustic) NaOH. In the wound bed these neutralizers are exchanged with ions from the wound fluid.
By using L-carnosine in the manufacturing (patent applied for), a biological buffer is incorporated in the product. L-carnosine is a natural skin factor from non-animal origin, that is used in many skin care applications and has been proven to scavenge ROS (radical oxygen species) as well as unsaturated aldehydes formed from peroxidation of cell membrane fatty acids during oxidative stress. Carnosine also interferes with skin protein cross-linking and glycation phenomena (7).
7. Giotto et al. 2005. Carnosine and Carnosine-Related Antioxidants: A Review. Current Medicinal Chemistry, 12, 2293-2315
Clinically proven
Patients with diverse wounds suitable for treatment with a hydrogel were selected to be treated with Flamozil. Most of the patients were treated ambulatory in the wound centre. Depending on the wound the patients returned to the wound centre for a consult either weekly, once every 2 weeks or once every 3 weeks. A photographic and clinical description was performed on a selection of 10 most illustrative cases (illustrative selection for diverse wound types and severity).
Both acute and chronic wounds were treated. The purpose of the treatment was mostly helping to debride necrotic tissue and/or fibrinous material. In dry wounds an additional purpose was keeping a moderately moist wound healing environment.
In chronic wounds there was a wide range of applications: ulcus cruris venosum, decubitus, arterial ulcers, vasculitis and oncologic wounds. As for acute wounds a couple of deep traumatic wounds were treated. Flamozil had a positive effect on the wound cleaning phase. It allowed sufficient hydration of a dry necrotic wound, which enhances autolytic debridement. This lead, a short while after, to a vital granulating wound bed. In low exsudating wounds, Flamozil can be used until the wound is grown up to skin level. The study suggested that fibrinous and necrotic wounds tended to evolve quicker to a granulation phase than with conventional hydrogels.
Available for Rx as well as OTC marketing
Flamozil is licensed out or supplied in several international territories. It is available for doctor driven wound care as well as over the counter markets such as sunburn, first aid, etc..
CE medical device class (EU/EEA)
Flamozil is a CE-marked medical device and is certified under ISO-standards 13485.
