Evidence map›Paper›PMID 36387967›Full record

ArticleClinical, cosmetic and investigational dermatology2022

Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults.

Dong Li, Zhanwei Gao, Jiaming Sun, Qin Li, Ping Jiang, Lijuan Zhang, Smita Chawla

Registry-linked trialAbstract read
In one paragraph

Article in Clinical, cosmetic and investigational dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03519204 (A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–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.

NCT03519204 nacompletednot on this map

A Randomized, Multicenter, No-treatment Controlled Study of the Safety and Effectiveness of JUVÉDERM® VOLBELLA® With Lidocaine for Lip Enhancement in Chinese Adults

TypeinterventionalSponsorAllerganRan2016 to 2018Enrolled176ConditionsLip EnhancementArmsJUVÉDERM® VOLBELLA® XC with Lidocaine, No-treatment Control
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. 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

7 authors.

Dong LiPeking University Third Hospital, Beijing, People's Republic of China.
Zhanwei GaoJapan Friendship Hospital, Beijing, People's Republic of China.
Jiaming SunUnion Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan, People's Republic of China.
Qin LiGeneral Hospital of Guangzhou Military Command of PLA, Guangzhou, People's Republic of China.
Ping JiangNanfang Hospital, Southern Medical University, Guangzhou, People's Republic of China.
Lijuan ZhangAllergan Aesthetics, an AbbVie Company, Beijing, People's Republic of China.
Smita ChawlaClinical Development, Allergan Aesthetics, an AbbVie Company, Irvine, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Hyaluronic acid (HA) soft tissue fillers are used to restore volume loss to the lips and perioral area. Objective: Evaluate the safety and effectiveness of the HA filler Juvéderm Methods & Materials: In this multicenter, evaluator-blind study, subjects seeking lip enhancement were randomized 3:1 to VYC-15L or no-treatment control group (with optional treatment delayed by 3 months). Effectiveness endpoints included 1-point improvement on the 5-point Lip Fullness Scale (LFS) assessed by evaluating investigators (EIs) and subjects, and overall volume of lips and change in lip surface area measured from 3-dimensional images. Safety assessments included procedural pain, injection site reactions (ISRs), and adverse events (AEs). Results: The modified intention-to-treat population included 163 subjects (median age, 34 years; 96.9% female). More VYC-15L-treated subjects had a 1-point reduction in EI-reported LFS score at month 3 versus untreated controls (84.7% vs 0%; Conclusion: VYC-15L treatment was superior to no treatment at 3 months and was well tolerated by subjects. Clinical Trial Registration Number: NCT03519204.

Indexed as

Chinadermal fillershyaluronic acid

Identifiers

PMID36387967
PMCPMC9661899

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Registered trials

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.