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Efficacy and Safety of Lidocaine and Tetracaine Cream for Facial Laser Aesthetics in Chinese Adults

NCT05793892 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2024-11-20

No results posted yet for this study

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.

Conditions

  • Analgesia

Interventions

DRUG

Lidocaine tetracaine cream

The test drug and the control drug will be uniformly spread over the treatment area using a tongue platula to form a thin layer of approximately 1 mm,right then left . The drug remained in the treatment area for 30 minutes (± 2 minutes) .

Sponsors & Collaborators

  • Cutia Therapeutics（Wuxi）Co.,Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-06
Primary Completion
2023-08-23
Completion
2023-10-25

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793892 on ClinicalTrials.gov