Evidence map›Paper›PMID 40296512›Full record

Trial reportJournal of cosmetic dermatology2025

Efficacy and Safety of Generic Fluocinolone Acetonide, Hydroquinone, and Tretinoin Cream Compared With TRI-LUMA for the Treatment of Moderate-To-Severe Melasma in Chinese Patients: A Randomized, Single-Center, Placebo-Controlled Trial.

Honghua Hu, Pengfei Zhou, Hongliang Yao, Chengyao Zhu, Bo Shen, Bo Feng, Xiangke Yu, Lunfei Liu

Abstract readRandomized Controlled TrialComparative Study
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 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Review
  2. Review
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

8 authors.

Honghua HuDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.ORCID https://orcid.org/0000-0002-0113-4786
Pengfei ZhouDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Hongliang YaoDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Chengyao ZhuDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.ORCID https://orcid.org/0009-0007-6782-146X
Bo ShenDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Bo FengDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Xiangke YuDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.
Lunfei LiuDepartment of Dermatology, The Fourth Affiliated Hospital of School of Medicine, and International School of Medicine, International Institutes of Medicine, Zhejiang University, Yiwu, China.

Funding

Scientific Research Fund of Zhejiang Provincial Education Department Y201839775Zhejiang Fonow Medicine Co. Ltd
6 · The paper itself

Abstract

backgroundTreatment with fluocinolone acetonide, hydroquinone, and tretinoin cream is the gold standard for melasma; however, the effects of this treatment in the Chinese population remain unclear. Due to the differences between Chinese and Caucasian subjects, further clinical trials in Chinese patients with melasma are needed.

aimTo evaluate the efficacy and safety of fluocinolone acetonide, hydroquinone, and tretinoin creams in Chinese patients with moderate-to-severe melasma.

methodsWe recruited 53 patients who received a generic formulation (triple combination cream, TCC), brand formulation (TRI-LUMA), or placebo once daily for 8 weeks. In weeks 4 and 8, efficacy was evaluated based on the Melasma Severity Scale and Melasma Area and Severity Index. In addition, safety was assessed based on the incidence and severity of treatment-emergent adverse events.

resultsThe generic TCC group achieved 52.2% efficacy compared to 57.1% in the TRI-LUMA group. There was no significant difference in the incidence of adverse effects between the TCC and TRI-LUMA groups (69.6% and 90.5%, respectively; p > 0.05). The incidence of adverse events in the placebo group was 0%.

conclusionGeneric TCC was as effective as TRI-LUMA and had a similar safety profile in this study of Chinese subjects with moderate-to-severe melasma.

Indexed as

Dermatologic AgentsDrugs, GenericFluocinolone AcetonideHydroquinonesMelanosisTretinoinAdministration, CutaneousAdultChinaDouble-Blind MethodDrug CombinationsEast Asian PeopleFemaleHumansMaleMiddle AgedDermatologic AgentsDrug CombinationsDrugs, GenericFluocinolone AcetonidehydroquinoneHydroquinonesTretinoinefficacyfluocinolone acetonide, hydroquinone, and tretinoin creammelasmasafety

Identifiers

PMID40296512
PMCPMC12038315

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Registered trials

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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.