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CLINICAL VALIDATION FOR RADIODERMATITIS RELIEF
radio
The clinical efficacy of a cosmetic product is rarely confirmed by histological and immunohistochemical analyses. These in-vivo studies with 15 women aged 35-65 of Fitzpatrick skin types II and III confirm that treatment with the snail serum leads to significant subjective (clinical signs and satisfaction) and objective (profilometry) improvements in cutaneous photoaging, confirmed by the improvement of subjects histopathological condition.

The reported study was done in 1999 with the snail serum as part of a base cream that is different than the ingredients and technology we use in BIOCUTIS products which allows for a more deeper penetration of the lotion into the skin and its proper release within the target cells.

Results are cumulative and best with continued use twice a day every day for a period of 2 months.

Dry Skin Cream
Facial Dry Skin
Severe Dry Skin Help
Chronic Occupational Radiodermatitis
Wheat Germ Oil Soap for Dry Skin

Acute radiodermatitis represents an important skin toxicity factor in patients undergoing radiotherapy, as they cause important loss of life quality and delays on radiotherapy schedules.

These deleterious effects indicate the need of adequate short-term measures to improve the patient’s health or at least to block further deterioration.

Up-to-date therapeutic options to prevent or heal adverse effects of radiotherapy are not able to meet the patient’s requirements. These include emollients and topic corticosteroids, although the latter are limited to brief periods of treatment due to their potential adverse effects.

Radiation induces skin damage and reduces its regenerative capability, affecting normal wound healing. Thus, potential treatment should induce, potentiate and/or accelerate the regenerative capability of damaged skin.

The glycoprotein secretion of land snails bears high antioxidant activity based on its ability to capture free radicals produced during irradiation and also to inhibit their production. In addition, it bears superoxide dismutase as well as gluthation-S-transferase antioxidant activities.

The secretion enhances proliferation and other functional capabilities of fibroblasts, inducing synthesis of skin elements required for wound healing. The secretion increases collagen synthesis, fibronectin deposition on the extracellular matrix and hyaluronic acid content.

Both the facilitating and promoter actions of the secretion on the mechanisms of cutaneous wound healing provide a rationale for its employment in the treatment of Radiodermatitis.

Clinical trials have confirmed its efficacy in blocking deterioration, prevention and treatment of acute radiodermatitis. One such study was published in 2001 and there have been further and more complete studies since then.

Biochemical and Pharmacological Mechanisms Related to the Activity of Cryptomphalus aspersa in Radiodermatitis. A. Brieva, A. Guerrero, J.P. Pivel. Dermatología & Cosmética, 2001. Investigations on the antioxidant activity: superoxide dismutase (SOD), conjugated enzymes such as glutathione-S-transferase (GSH-T), and low molecular weight antioxidants of Crystomphalus aspersa snail secretion.

A recent study (2007) has evaluated the efficiency and tolerance of Radiocare®, a product which includes snail secretion and is made by a Spanish pharmaceutical company, in the prevention and treatment of acute radiodermatitis (Grade: I-II) in patients diagnosed with breast carcinoma, about to initiate or undergoing radiotherapy treatment.

Type of study: Open, controlled, multicentric study.

Population: 96 women, diagnosed with breast carcinoma, mean age of 55 years. Irradiation model: Early breast cancer: (50Gy / 25 fractions of 200cGy / 5wks + 10-16 Gy to the tumor area).

Design: Patients were divided into three arms:

1. Control arm (Standard treatment): 22 patients, who received normal treatment, according to the degree of skin toxicity.

• No toxicity: No treatment.
• Grade I toxicity: Camomile water
• Grade II toxicity: Topic corticosteroids (Fluocinolone acetonide) 1/d

2. Preventive Radiocare® arm: 33 patients, who received Radiocare® preventively, once a day, from the beginning of radiotherapy to its end.

3. Curative Radiocare® arm: 41 patients undergoing radiotherapy, who received Radiocare® if they presented acute radiodermatitis lesions, grades I and II. Every patient within this group received daily treatment with Radiocare from the moment of detection of the wounds until their remission.

Clinical and photographic evaluation: Initial evaluation, followed by weekly revision during radiotherapy treatment. After completion of the radiotherapy, repeated evaluations were conducted after 1, 2 and 4 weeks. Toxicity was scored according to benchmark objective criteria and to patients symptoms: itching, pain, erythema, desquamation.

Evaluation of the level of satisfaction of both the patient and the investigator was done for different aspects such as product presentation, handling, tolerance and therapeutic efficiency.

Conclusion: Results have demonstrated the efficiency of treatment with snail secretions in the resolution of Acute Radiodermatitis, in a statistically similar fashion or even better compared to standard treatment.

According to these results, treatment with a product with snail secretions:

• Does not cause adverse effects, not even during prolonged therapy.
• It does not interfere with radiotherapy.
• Employed in a Curative or Preventive way, it is as efficient as standard treatment (camomile water and corticosteroids) or even better.
• Preventive treatment is significantly more beneficial regarding evolution of radiodermatitis.
• Radiocare has been favoured by both Patients and Investigators, being more satisfactory than standard treatment.

The regenerative mechanism of action of the snail secretion results in clinical amelioration of lesions caused by Acute Radiodermatitis, supporting its predominance over emolients. The lack of local and/or sistemic adverse effects in long treatments provide a rationale for its election for radiodermatitis instead of topical corticosteroids as well as a powerfull skin antioxidant for the treatment of aging skin.

Not only were the results processed by the instruments used to measure them positive, the subjects all had positive visual results, according to their journal entries. All study participants were happy with the topical treatment of photoaging in the study. Firmness, elasticity, and all the other side effects of excessive sun exposure were improved using the product with snail serum as a topical agent. Users' subjective comments indicate considerable comfort and satisfaction with the results of the experience.

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