P7045 A NEW APPROACH BASED ON SHBF FOR THE MANAGEMENT OF ERYTHEMA
P-7045 is a topical formulation for the prevention and treatment of cutaneous alterations
what
how Lenitive factor for skin against damaging agents A topical formulation specifically developed as lenitive in case of erythema. Good compliance and improvement in dermal functionality has been proved through clinical studies. Treatment of skin irritated by mechanical stripping showed boosting effect to regenerate the physiological status better than topical drug containing hydrocortisone used as comparison. On patients under radiotherapeutic treatment, P7045 has been applied following a clinical protocol built to maximize the protective activity without affecting on the efficacy of the therapy. Erythema by ionizing irradiation has been managed and negative side effects minimized, avoiding reduction or stopping of cycles with a positive effect in term of succes of therapy. Claiming activity against iatrogenic and exogeneous induced erythema, P7045 has been registrered as class 2A medical device.
SINERGY OF THE PERFECT MIX TO PROTECT AND REGENERATE
CLINICAL STUDIES & TESTS
DERMOCOSMETIC FUNCTIONALITY Clinical trials show for all cosmetic functionality tested, a really significant increase in comparison with the reference without SHBF, particularly concerning effects on moisturization and biological elasticity.
VARIATION % VS BASELINE
STRIPPING TEST
(MEAN VALUE)
Placebo P7045
A clinical study on mechanical induced erythema was conducted in 20 volunteers, comparing P7045 to hydrocortisone butyrate cream (reference product). As a result P7045 showed a significant soothing and a re-epithelizing activity similar to the one obtained with the reference product.
(MEAN VALUE)
VARIATION % VS BASELINE
ERYTHEMA INDEX (OPTICAL COLORIMETRY)
In two studies on volunteers P-7045 has been tested for its effect on different skin parameters: Moisturization Elasticity Smoothness Scaliness
SUPPORTIVE CARE IN RADIOTHERAPY In an open clinical study 34 patients undergoing radiotherapy were treated with P-7045 (twice/day) as soon as signs of erythema of 1st degree were evident. Therapeutic protocols were concluded without reduction or interruption of the radiation dose Clinical results indicate a favourable safety profile, encouraging efficacy data and excellent dermo-cosmetic properties.
CONCLUSIONS P-7045 is the answer, steroid and drug-free, for the management of dermatitis induced by different causes (sun, stripping, burns, ionizing irradiation) and the restoration of the cutaneous layer in subjects with erythema.
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