Clinical trial NCT05793892: Efficacy and Safety of Lidocaine and Tetracaine Cream for Facial Laser Aesthetics in Chinese Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Analgesia
Lead sponsor: Cutia Therapeutics（Wuxi）Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2023-03-31
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: test drug：Lidocaine tetracaine cream（CU-30101） control drug：Lidocaine tetracaine cream（Pliaglis®）
Primary purpose: PREVENTION

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 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.

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.

Eligibility criteria: Inclusion Criteria:

* (1) fully informed, fully understand the trial content, process, benefits and possible adverse reactions, and voluntarily participate in the trial, and sign the informed consent;
* 2、Aged 18-65 years old (including the boundary value), gender is not limited;
* (3) Body mass index (BMI) between 18.5-28.0 kg/m2 (including the boundary value);
* (4) plan to perform facial lattice laser cosmetic;
* (5) The subject can communicate well with the investigator and can complete the study in accordance with the provisions of the study.

Exclusion Criteria:

* (1) At screening, the investigator judged that the subject has facial skin damage, peeling, tattoo, scar, atopic dermatitis, urticaria or other skin diseases that may interfere with the study objectives and evaluation;
* (2) sensory disturbance, hyperalgesia, migraine, herpes zoster, trigeminal neuralgia and other head and facial pain affect the efficacy evaluation;
* (3) Those who have used any analgesics within 24 hours before surgery;
* (4) Patients with allergic constitution \[to two or with substances (dust, pollen, food, drugs, etc.)\], or known to be allergic to lidocaine, tetracaine or other amide or ester local anesthetics and its excipients or p-aminobenzoic acid (PABA);
* (5) Those who are sensitive to systemic effects of lidocaine and tetracaine (such as acute disease, severe liver disease or pseudocholinesterase deficiency);

Primary outcomes:
measure: the VAS score of immediate pain
timeFrame: after each side lattice laser cosmetic surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People Hospital,Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Beijing
country: China
facility: Beijing Hospital
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
city: Beijing
country: China
facility: Peking University Shougang Hospital
city: Changsha
country: China
facility: Xiangya Hospital Central South University
city: Chendu
country: China
facility: West China School of Medicine West China Hospital of sichuan university
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
city: Guangzhou
country: China
facility: Nanfang Hospital/Guangzhou
city: Nanjing
country: China
facility: Jiangsu Province Hospital
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical college huazhong university of science and technology
city: Xuzhou
country: China
facility: The affiliated hospital of xuzhou medical university
Study officials:
References: