Efficacy and Safety of Lidocaine and Tetracaine Cream for Facial Laser Aesthetics in Chinese Adults
Status:
Not yet recruiting
Trial end date:
2023-09-12
Target enrollment:
Participant gender:
Summary
Lattice laser is a new medical cosmetic technology, which is a kind of noninvasive and
invasive technology. Compared with traditional laser therapy, lattice laser has a wider range
of clinical use, and can be used to treat skin problems such as acne marks, fine wrinkles,
skin aging, chloasma, coffee spots, large pores and dullness. Dot-array laser has been widely
used in the treatment of skin diseases and skin cosmetics because of its advantages of small
trauma, rapid recovery, safety and effectiveness, and fewer complications. The facial skin is
rich in nerve fibers and pain receptors are distributed punctuately. Most patients have pain
and discomfort to varying degrees during laser treatment. The pain and discomfort associated
with laser treatment of the face make anaesthesia an important assistant technique in laser
skin cosmetology. At present, the commonly used anesthesia methods to relieve pain include:
local cooling anesthesia, topical anesthesia, general anesthesia, gas inhalation anesthesia,
intravenous anesthesia, iontophoresis anesthesia, etc. General anesthesia is usually
associated with a risk of complications, residual areas of regional nerve block are often
sensitive to pain, and acupuncture and drug injection can increase patient discomfort.
Therefore, because of its simplicity and convenience of drug administration, topical
anesthesia has a positive significance in facial lattice laser cosmetic treatment. The
reference product lidocaine tetracaine cream (brand name: Pliaglis ®) has been marketed in
the United States and the European Union for many years, and its therapeutic efficacy has
been clinically recognized and has a good safety profile.Lidocaine tetracaine cream (R & D
code: CU-30101) is manufactured by Cutia Therapeutics (Wuxi) Co., Ltd . A randomized,
double-blind, multi-center clinical study is currently proposed to evaluate the efficacy and
safety of CU-30101 in facial spot-array laser cosmetology in Chinese subjects with Pliaglis ®
as a control.