Evidence map›Paper›PMID 30623408›Full record

Trial reportThe British journal of dermatology2019

Efficacy and safety of PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild-to-moderate atopic dermatitis: a phase IIb randomized trial.

Y W Lee, C-H Won, K Jung, H-J Nam, G Choi, Y-H Park, M Park, B Kim

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of dermatology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 2 pooled it
8.2field-weighted citation impact, top 2% of its field
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

44 citing papers in PubMed, 2 syntheses or guidelines pooled it, 82 citations in OpenAlex.

  1. Pooled it
  2. Topical anti-inflammatory treatments for eczema: network meta-analysis.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Review
  4. TRPV1 antagonism occurs through diverse structural mechanisms.bioRxiv : the preprint server for biology · 2026
    Article
  5. Review
  6. Article
  7. The stem ofFrontiers in immunology · 2026
    Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Prurigo Nodularis: Pathogenesis and the Horizon of Potential Therapeutics.International journal of molecular sciences · 2024
    Review
  14. Review
  15. Novel Topical Treatments for Itch.Dermatology and therapy · 2024
    Review
  16. Article
  17. Review
  18. Review
  19. Challenges and Future Trends in Atopic Dermatitis.International journal of molecular sciences · 2023
    Review
  20. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

8 authors at 4 institutions in 1 country.

Y W LeeDepartment of Dermatology, Konkuk University School of Medicine, Seoul, Republic of Korea.
C-H WonDepartment of Dermatology, Ulsan University College of Medicine, Asan Medical Center, Seoul, Republic of Korea.
K JungVital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.
H-J NamVital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.
G ChoiVital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.
Y-H ParkVital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.
M ParkVital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.ORCID 0000-0003-3598-5420
B KimDepartment of Dermatology, Chung-Ang University College of Medicine, Seoul, Republic of Korea.
Amorepacific (South Korea) · KRAsan Medical Center · KRChung-Ang University · KRKonkuk University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransient receptor potential vanilloid subfamily, member 1 (TRPV1) may play an important role in pruritus and inflammation induction in atopic dermatitis (AD). The treatment effect of TRPV1 antagonist via topical application in patients with AD remains unknown.

objectivesTo assess the clinical efficacy and safety of PAC-14028, a TRPV1 antagonist, via topical application in patients with AD.

methodsIn this 8-week, phase IIb, randomized, double-blind, multicentre, vehicle-controlled study, patients with mild-to-moderate AD were randomized to receive PAC-14028 cream 0·1%, 0·3%, 1·0% or vehicle cream twice daily. The primary efficacy end point was the Investigator's Global Assessment (IGA) success rate defined as the percentage of patients with an IGA score of 0 or 1 at week 8. The secondary efficacy end points included the severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index (EASI) 75/90.

resultsA total of 194 patients were enrolled. IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (P = 0·0025 vs. vehicle), 38·30% for PAC-14028 cream 0·3% (P = 0·0087 vs. vehicle) and 57·45% for PAC-14028 cream 1·0% (P < 0·001 vs. vehicle). In particular, statistically significant differences were found between the vehicle and treatment groups in the IGA success rates with two-grade improvement. The SCORAD index, EASI 75/90, sleep disturbance score and pruritus visual analogue scale showed a trend towards improvement. No significant safety issues were reported.

conclusionsPAC-14028 cream may be an effective and safe treatment modality for the treatment of patients with mild-to-moderate AD.

Indexed as

AcrylamidesAdultAnti-Inflammatory AgentsDermatitis, AtopicDose-Response Relationship, DrugDouble-Blind MethodFemaleHumansMaleMiddle AgedPruritusPyridinesSeverity of Illness IndexSkin CreamTreatment OutcomeTRPV Cation ChannelsAcrylamidesAnti-Inflammatory AgentsN-(1-(3,5-difluoro-4-methanesulfonylaminophenyl)ethyl)-3-(2-propyl-6-trifluoromethylpyridine-3-yl)acrylamidePyridinesTRPV1 protein, humanTRPV Cation Channels

Identifiers

PMID30623408
PMCPMC6850419
OpenAlexW2909482080

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.