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Friday, 13 February 2015 17:14

Technical Report: In Vitro Evaluation of the Safety Profile of PracaSil™-Plus on Human Melanoma Tissue

Introduction:

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Melanoma is a cancerous condition that arises from unregulated growth of melanocytes (pigmented cells), resulting in tumor production on the skin (most common) and mucous membranes. The unregulated growth of melanocytes can be divided into two phases: radial growth phase (RGP), represented by slow proliferation of cells in the epidermis; and vertical growth phase (VGP), a more advanced phase with presence of nodules. Depending on the growth phase of the melanocytes and the aggressiveness of the tumor, melanoma may be classified into one of 5 stages: stage 0 is the least severe while stage 4 is the most severe. With the exception of stage 4, treatment of melanoma involves initial surgical removal of the tumor, which results in skin scarring, the imperfect but normal end point of tissue repair. Unfortunately, scars cannot yet be made to disappear, and may range from a desirable fine line to a variety of abnormal scars, including hypertrophic and keloid scars. Skin scarring is often considered trivial but may also be aesthetically unpleasant and disfiguring, causing distress, anxiety and other psychosocial consequences. Scars may also have physical consequences as tenderness, itching and pain, which is functionally disabling and contributes to diminished quality of life.

Taking into account that clinical treatments do not entirely eliminate skin scarring, the therapeutic goal is to reduce, as much as possible, the severity of scars. However, not only are scars different but there is also considerable qualitative and quantitative variability in skin scarring between individuals. Consequently, clinical treatments should envisage a personalized approach and be adapted to both the scar and patient specificities. For this reason, plastic surgery and various medication for scar treatment are commonly used to help restore the appearance of the tissue. PracaSil-Plus is a proprietary anhydrous silicone base developed to be applied topically in scar and wound management therapy, either alone or as a base for incorporation of different active substances to facilitate skin regeneration and healing.

Therefore, the purpose of this study was to evaluate the safety profile of PracaSil-Plus on the progression of melanoma, using the MLNM-FT-A375 human melanoma tissue model.

Abstract:

Melanoma is a cancerous skin condition that often leads to surgical removal of the affected tissue, which results in skin scarring. Scars may not only be aesthetically unpleasant but may also have physical consequences such as pain and psychosocial consequences (e.g., anxiety, distress). PracaSil-Plus is a proprietary anhydrous silicone topical base used alone or as a base for incorporation of different active substances to facilitate skin regeneration and healing. The purpose of this study was to evaluate the safety profile of PracaSil-Plus on the progression of melanoma, using the MLNM-FT-A375 human melanoma tissue model. Results have demonstrated that PracaSil-Plus did not contribute to the progression of melanoma cells when compared to untreated tissues. Therefore, PracaSil-Plus may be regarded as a safe treatment option to be used by compounding pharmacists in scar management therapy.

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Figure 1. Melanoma tissue model 3 days post-treatment (40x magnification).

 

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Figure 2. Melanoma tissue model 14 days post-treatment (100x magnification).

Conclusions:

Melanoma is a cancerous skin condition that often leads to surgical removal of the affected tissue, which results in skin scarring. Scar patients are likely to seek clinical treatment, particularly for abnormal scars, as skin scarring is often associated with substantial emotional and financial costs. Compounding pharmacists may then have a critical impact in scar and wound management therapy by dispensing personalized topical formulations.

The in vitro evaluation of the safety profile of PracaSil-Plus has demonstrated that this topical base did not contribute to the progression of melanoma cells within the human tissue model. Topical application of PracaSil-Plus can thereby be considered safe as there were no significant differences between the progression of melanoma in tissues treated with PracaSil-Plus versus the untreated tissues.

The favorable safety profile demonstrated by PracaSil-Plus is promising data to suggest that this topical base can be used in pharmaceutical compounding as a safe treatment option for patients in scar management therapy.

Download the complete PDF detailing the results of this study.

Click to learn more about PracaSil-Plus.