Evidence map›Paper›PMID 40735955›Full record

Trial reportJournal of cosmetic dermatology2025

Efficacy and Safety of Combined Topical Lidocaine and Tetracaine Cream for Facial Fractional Laser Resurfacing Compared With Its Reference Product in Chinese Adults: A Multicenter, Randomized, Double-Blind Phase 3 Study.

Wenxin Yu, Zhongling Luo, Yi Zhao, Zhiqi Hu, Aijun Zhang, Yong Li, Juan Tao, Xiaosong Chen, Haiying Wang, Liying Chen and 2 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Journal of cosmetic dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors.

Wenxin YuDepartment of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Zhongling LuoDepartment of Dermatology, Xiangya Hospital, Central South University, Changsha, China.
Yi ZhaoDepartment of Dermatology, Beijing Tsinghua Changgung Hospital, Beijing, China.
Zhiqi HuDepartment of Plastic Surgery, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Aijun ZhangDepartment of Plastic Surgery, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Yong LiDepartment of Dermatology and Venereology, West China Hospital, Sichuan University, Chengdu, China.
Juan TaoDepartment of Dermatology and Venereology, Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Xiaosong ChenDepartment of Plastic Surgery and Regenerative Medicine, Fujian Medical University Union Hospital, Fuzhou, China.ORCID https://orcid.org/0000-0002-3780-5510
Haiying WangDepartment of Dermatology and Venereology, Peking University Shougang Hospital, Beijing, China.
Liying ChenCutia Therapeutics Co., Ltd, Wuxi, China.
Hanjie ZhuCutia Therapeutics Co., Ltd, Wuxi, China.
Xiaoxi LinDepartment of Laser and Aesthetic Medicine, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.

Funding

Cutia Therapeutics Co. Ltd
6 · The paper itself

Abstract

backgroundAs a potentially effective anesthetic, CU-30101 is comprised of 7% lidocaine and 7% tetracaine and is a generic drug of Pliaglis. This study aimed to investigate the equivalence between CU-30101 and Pliaglis as topical anesthetics for fractional laser.

methodsThis Phase 3 trial recruited Chinese adults scheduled for facial fractional laser resurfacing. Participants were randomized to receive opposite treatment sequences of CU-30101 and Pliaglis on contralateral sides of the face prior to laser application. Visual Analog Scale (VAS), participant and investigator satisfaction ratings, local tolerability, and safety were assessed.

resultsTwo hundred eighty-four participants completed the study, with mean VAS scores of 35.3 ± 24.51 for CU-30101 and 37.3 ± 24.17 for Pliaglis. The 95% confidence interval of -3.78 to -0.13 for the VAS difference laid within the predefined equivalence margin of ±4.7, confirming equivalence in efficacy. The results in the per-protocol set further corroborated the equivalence. Both participants and investigators expressed consistently high satisfaction with CU-30101 and Pliaglis. Furthermore, both treatments were well tolerated and exhibited favorable safety profiles.

conclusionThis study demonstrated the equivalent efficacy of CU-30101 to its reference product, Pliaglis, among Chinese adults undergoing facial fractional laser resurfacing. CU-30101 showed commendable local tolerability and safety profiles, consistent with those of Pliaglis.

Indexed as

Anesthetics, LocalLaser TherapyLidocaineSkin AgingTetracaineAdministration, CutaneousAdultChinaDouble-Blind MethodDrug CombinationsEast Asian PeopleFaceFemaleHumansMaleMiddle AgedAnesthetics, LocalDrug CombinationsLidocaineTetracaineefficacyequivalencefractional laserlidocainesafetytetracaine

Identifiers

PMID40735955
PMCPMC12308782

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.