Ignite Creation Date:
2024-05-06 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05793892
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-03-31
First Post:
2023-03-09
Brief Title:
Efficacy and Safety of Lidocaine and Tetracaine Cream for Facial Laser Aesthetics in Chinese Adults
Sponsor:
Cutia TherapeuticsWuxiCoLtd
Organization:
Cutia TherapeuticsWuxiCoLtd
Study Overview
Official Title:
A Phase III Clinical Study of the Efficacy and Safety of Lidocaine and Tetracaine Cream CU-30101 in a Multicenter Randomized Double-Blind Active-Controlled Paired Design for Facial Laser Aesthetics in Chinese Adults
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 profileLidocaine 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
Detailed Description:
On the one hand MTZ can self-repair stimulate collagen regeneration and improve skin texture on the other hand due to the small area of MTZ injury the surrounding normal skin tissue can be rapidly repaired reduce the risk of treatment and shorten the recovery time 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 In accordance with the Chemical Drug Registration Category and Application Dossier Requirements NMPA 2020 No 44 lidocaine tetracaine cream R D code CU-30101 manufactured by Corde Biopharmaceuticals Wuxi Co Ltd is registered as a chemical class 3 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None