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

NCT05793892 | Completed Phase 3

• 1 other identifier: CU-30101-304
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 11

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.

Conditions

Analgesia

Outcome Measures

Primary Outcomes (1)

• the VAS score of immediate pain

  The subjects completed the VAS score of immediate pain at the test drug site and the control drug site after each side lattice laser cosmetic surgery;

  after each side lattice laser cosmetic surgery

Study Arms (2)

Arm A

EXPERIMENTAL

The order of administration of the test drug in both treatment areas in Arm A is the first, followed by the use of the control drug.

Drug: Lidocaine tetracaine cream

Arm B

ACTIVE COMPARATOR

The order of administration in both treatment areas in Arm B was the use of the control drug first, followed by the investigational drug.

Drug: Lidocaine tetracaine cream

Interventions

Lidocaine tetracaine cream DRUG

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) .

Also known as: test drug:CU-30101, control drug:Pliaglis

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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;
• 、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.

You may not qualify if:

• (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);

Sponsors & Collaborators

• Cutia Therapeutics（Wuxi）Co.,Ltd: lead

Study Sites (11)

Shanghai Ninth People Hospital,Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200011, China

Location

Beijing Hospital

Beijing, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

Peking University Shougang Hospital

Beijing, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

West China School of Medicine West China Hospital of sichuan university

Chendu, China

Location

Fujian Medical University Union Hospital

Fuzhou, China

Location

Nanfang Hospital/Guangzhou

Guangzhou, China

Location

Jiangsu Province Hospital

Nanjing, China

Location

Union Hospital, Tongji Medical college huazhong university of science and technology

Wuhan, China

Location

The affiliated hospital of xuzhou medical university

Xuzhou, China

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: test drug：Lidocaine tetracaine cream（CU-30101） control drug：Lidocaine tetracaine cream（Pliaglis®）

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 31, 2023
• Study Start: April 6, 2023
• Primary Completion: August 23, 2023
• Study Completion: October 25, 2023
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (11)