Clinical Studies

neoVIDERM CLINICAL STUDIES:

Cutaneous Reaction Prevention with the Use of “Neoviderm Skin Emulsion” in Head and Neck External Beam Radiotherapy (EBRT) and Perioperative-Brachytherapy (BRT) for Breast Cancer.

TUMORI. XIX AIRO 2009. Bologna. 14-17 November 2009. vol. supplemento 8 n 1, pp. S10 ISSN: 0300-8916

Ceconi, A. Guido, S. Cammelli, F. Bunkheila, M. Micucci, A. Pepe, E. Barbieri, and L. Busutti.

Department of Radiotherapy, S. Orsola-Mapighi Hospital, Bologna University, Italy.

Neoviderm Skin Emulsion was used twice a day during treatment and once a day for six months later in breast cancer and head and neck cancer patients. During the period, the patient was evaluated with objective analysis (RTOG-SOMA LENT) and evaluated for superficial cutaneous damage, skin elasticity, and superficial changes (hyperpigmentation, epilation, skin dryness, telangiectasia).

No evidence of Grade 3 and above dermatitis was observed and with a single case of Grade 2 dermatitis, the use of Neoviderm improved skin elasticity, reduced skin dryness and the risk of cutaneous erythema. No patient needed topical corticosteroid during therapy.

Topic Treatment with Neoviderm Cream to Prevent and Reduce Skin Toxicity in Patients Receiving Radiotherapy for Breast Cancer.

TUMORI. XIX AIRO 2009. Bologna 14-17 November 2009

M. A. Mirri., P. Soldini, F. Pichinelli, T. Palloni, F. Fabretti, A. Ciabattani,

UOC Radioterapia, A.C.O. S. Fillppo Neri, Roma, Italy.

A total of 25 patients underwent radiotherapy treatment for breast cancer and received Neoviderm Skin Emulsion three times a day one week before, during treatment and one month after treatment.

The results showed that the rate of Grade 1 and 2 dermatitis was 12%, with no presence of Grade 3 and above. No patient needed to interrupt treatment.

Randomized Trial on the Efficacy of Two Non Steroidal Drugs in the Prevention of Skin Damage Induced by Radiotherapy.

Journal Plastic Dermatology. 2009. 5:233-239

E. Garibaldi, M. Gatti, M. Gardes, E. Raiteri, E. Delmastro, C. Bona, G. Maliverni, P. Gabriele.

Radiotherapy Department, Institute for Cancer Research and Treatment, IRCC, Candiolo (TO), Italy.

Of a total of fifty four breast cancer patients and twelve head and neck cancer patients, half received Neoviderm twice a day started from the first day of therapy until ten days after treatment. Neoviderm was administered three hours before treatment and immediately after treatment. Acute skin toxicity was assessed by RTOG-EORTC scale.

The results showed that of the twenty six breast cancer patients receiving Neoviderm, four demonstrated Grade 2 dermatitis and no evidence of Grade 3 and above dermatitis. For the six head and neck cancer patients receiving Neoviderm, no patient developed Grade 2 and above dermatitis. Full resolution of the observed Grade 1 dermatitis was rapid compared to control alginate formulation.     

Triple Action for the health of the skin.

  PROTECTIVE & MOISTURIZING ACTION 

   Moisturization index

The pre-treatment with 5% of Plerasan™, contained in neoVIDERM induces a higher barrier capacity and an increase of moisturizing level.

RESULTS: The treatment increases skins moisturize levels after UV lamp radiation.

   SOOTHING ACTION

   SOOTHING efficiency tested against Chlorpheniramine  
   Maleate after 1.5 MED of increasing time interval radiation
   control.

Plerasan™ 5% vs Chlorpheniramine Maleate 1% (CM)

RESULTS: until 1.5 MED doses, there is not statistically significant difference between both active ingredients.

  REGENERATING ACTION

        

RESULTS: the normalization time of the skin using Plerasan™ is shorter compared to the controls.

The Plerasan™ treatment contained in neoVIDERM reduces:  

·         Inflammation in 75% of patients;

·         Swelling in 59% of cases;

·         Exudation in 78% of cases.