Supervisors info:
Ράλλης Μιχαήλ, Αναπληρωτής καθηγητής Φαρμακευτικής Τεχνολογίας, Τμήμα Φαρμακευτικής, Εθνικό και Καποδιστριακό Πανεπιστήμιο Αθηνών
Τάγκα Άννα, Διευθύντρια Ε.Σ.Υ., Α’ Κλινική Αφροδισίων και Δερματικών Νόσων Ιατρικής Σχολής Ε.Κ.Π.Α., Νοσοκομείο Αφροδισίων και Δερματικών Νόσων «Ανδρέας Συγγρός»
Summary:
The basal cell carcinoma is a locally invasive tumor of epithelial origin. It is considered the most common type of skin cancer in Caucasians and is characterized by slow growth, while it is rarely metastasises. It is treated with the method of cryosurgery, as it causes irreversible tissue damage due to the formation of intracellular and extracellular ice. The result of the treatment is the formation of an ulcer in the area of the lesion. Healing of skin wounds is a complex and often time- consuming process, which can lead to health complications, if not completed effectively, In the majority of skin lesions form necrotic tissue or rash tissue, which is used as a substrate for the development of microbial load and significantly slows down the healing process. In clinical practice, necrotic tissues are usually removed by surgical methods (debridement), however this method is characterized by causing pain, bleeding and eventual postponement of healing. For this reason, the use of proteolytic enzymes for wound healing is being investigated, as it seems to contribute to the breakdown and elimination of tissue rash without the disadvantages of surgical removal.
Strong preclinical data from studies performed in the laboratory of small animals of the Department of Pharmaceutical Technology of the National and Kapodistrian University of Athens using a dispase gel at a dose of 5U / ml, after the formation of tissue rashes, significantly helped to remove the skin and help the skin to heal.
At the present clinical study, a 5U / ml dispase gel was applied once every three days in comparison with a drug reference that contains octenidine to investigate the healing as well as their possible preventive effect on the formation of tissue rashes. Gel formulated with Sepigel 305 to minimize possible toxicity. The cryosurgery was followed by application of the gels until complete healing was achieved.
An open label, parallel groups, comparative study was designed. Sixteen patients who came for cryosurgery and met the necessary criteria were assigned to receive the reference medicine daily or the gel that we formulated once every three days. Twelve of them successfully completed all follow-up days for 21 days, while 8 also underwent the re-examination on day 60. The evaluation of the healing effect, safety and tolerance was done on days 1,2,7,21 and 60, through of the clinical evaluation, photographs of skin and biomechanical measurements such as hydration of the area. The end point of the study was considered either the complete healing of the ulcer or the 8th week from the beginning of the administration. The analysis of the results is a first indication in humans showing that the dispase gel shows faster healing compared to the reference drug, however considering a small sample size.
Keywords:
wound healing, ulcers, basal cell carcinoma, BCC,debridement, skin pharmacology, dispase, octenidine, clinical study
