TITLE:
Safety and Efficacy of PTCTS Cosmetic Gel: Study on Human Radiodermatitis Lesions
AUTHORS:
Silvia Regina Graziani, Brigitte M. Van Eyll, Carlos Elias Fristachi, Maria de Lourdes Higuchi, Renata Ikegami, Jose Antonio Ramires
KEYWORDS:
Radiodermatitis, Nanoparticles, Thermal Water, Transialidase, Toxicity, PTCTS Cosmetic Gel
JOURNAL NAME:
Case Reports in Clinical Medicine,
Vol.4 No.10,
October
15,
2015
ABSTRACT: Radiodermatitis is a constant complication after radiotherapy with no efficient drug for prevention and treatment. Its physiopathology is complex, possibly related to injury of epidermis and endothelial cells from the basal layer by radiolysis, overproduction of free radicals, pro-inflammatory cytokines, and inflammation. PTCTS gel is an after sun cosmetic gel composed by anti-oxidative plant extract rich in natural nanoparticles and thermal water (Complex A) and recombinant protein of Trypanosoma cruzi transialidase (Complex B), with high anti-oxidative and anti-apoptotic effects, presenting anti-aging and healing cutaneous properties. Objective: To study the safety and efficacy of PTCTS gel for topic use in volunteer subjects with healthy skin, and in patients with radiodermatitis, in different concentrations of Complexes A and B. Material and Methods: The project was approved by the Ethical Committee of Arnaldo Vieira de Carvalho Institute, Sao Paulo, Brazil. The individuals were submitted to laboratorial toxicity study through tests for liver and kidney function, levels of blood glucose and blood count before and after 7 days of PTCTS application. We studied two groups: GI-22 volunteers with healthy skin, presenting articular or skeletal muscle pain and GII-38 patients in radiotherapy for breast or head and neck cancer, with radiodermatitis grade 2 or 3. The patients were evaluated before and after 1.0 ml/cm2 PTCTS gel application, twice a day. We tested Complex B in four different concentrations, and Complex A concentrations varied inversely. Results: No irritation signs were observed in GI nor GII group, 64% of GI had important decrease in the intensity of the muscular or articular pain, and 99% of GII showed regression of radiodermatitis, all exhibiting relief of pain. No patient presented hematologic, renal or hepatic toxicity. Conclusion: PTCTS cosmetic gel is a safe option for radiodermatitis treatment, with no side effects or laboratorial toxicity in different concentrations. This product presented excellent clinical results even if used diluted 4 times more than the original product and may be a good option for treatment of radiodermatitis. Further studies may show if it is also indicated in the prevention of the lesion, and if it is better than products containing corticoids.