AnalgesiaPhase 3NCT05793892
Efficacy and Safety of Lidocaine and Tetracaine Cream for Facial Laser Aesthetics in Chinese Adults
A Phase 3 study testing Lidocaine tetracaine cream in people with Analgesia, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 11 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Lidocaine tetracaine cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 11 sitesChina
- Study dates
- 6 Apr 2023to 25 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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);
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Beijing Hospital
Beijing
Beijing Tsinghua Changgung Hospital
Beijing
Peking University Shougang Hospital
Beijing
Xiangya Hospital Central South University
Changsha
West China School of Medicine West China Hospital of sichuan university
Chendu
Fujian Medical University Union Hospital
Fuzhou
Nanfang Hospital/Guangzhou
Guangzhou
Jiangsu Province Hospital
Nanjing
Shanghai Ninth People Hospital,Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200011
Union Hospital, Tongji Medical college huazhong university of science and technology
Wuhan
The affiliated hospital of xuzhou medical university
Xuzhou
About this study
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
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.
Read the 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.
- Conditions
- Analgesia
- Being tested
- Lidocaine tetracaine cream
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine tetracaine creamDrug
Also called test drug:CU-30101, control drug:Pliaglis
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) .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Lidocaine tetracaine cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: after each side lattice laser cosmetic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start6 Apr 2023
- Primary completion23 Aug 2023
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- test drug：Lidocaine tetracaine cream（CU-30101） control drug：Lidocaine tetracaine cream（Pliaglis®）
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793892
- Sponsor's protocol ID
- CU-30101-304
- Status last verified
- Nov 2024
- First submitted
- 9 Mar 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05793892
- Acronym / sponsor ID
- CU-30101-304
- Conditions
- Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Cutia Therapeutics（Wuxi）Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2023 (actual)
- Primary completion
- 23 Aug 2023 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- test drug：Lidocaine tetracaine cream（CU-30101） control drug：Lidocaine tetracaine cream（Pliaglis®）
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Lidocaine tetracaine creamThe 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. |
| Arm B | Active comparator | Drug: Lidocaine tetracaine creamThe order of administration in both treatment areas in Arm B was the use of the control drug first, followed by the investigational drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- (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.
Key exclusion criteria (5 listed)
- (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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine tetracaine creamAlso: test drug:CU-30101, control drug:PliaglisThe 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) . | Drug | Arm A, Arm B |
Primary outcome
the VAS score of immediate pain
Time frame: after each side lattice laser cosmetic surgery
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;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine tetracaine cream in people with Analgesia, run by Cutia Therapeutics（Wuxi）Co.,Ltd at 11 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the VAS score of immediate pain (time frame: after each side lattice laser cosmetic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.