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CompletedNCT04365140Updated Apr 29, 2020

MicroRNA-126 and Its Target VCAM-1Dermatitis to Nickel

An observational study in Allergic Contact Dermatitis, sponsored by Universidad Autonoma de San Luis Potosí. Completed at 1 site in Mexico. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-04-29.

Sponsored by Universidad Autonoma de San Luis Potosí · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
15
Ages
18 Years to 60 Years
Sex
All
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Study summary

Background. Allergic Contact Dermatitis (ACD) is an inflammatory skin disease mediated by direct contact with allergens as nickel, the most common allergen, that may be related with epigenetic changes.

Objective. Evaluate the miR-126 expression and its target VCAM-1, in the skin of patients with ACD to nickel.

Methods. Fifteen patients with positive patch test to nickel were included, and the expression of miR-126 and VCAM-1 was evaluated by RT-qPCR.

Read the detailed description

Patients that went to the dermatology and outpatient department of the Central Hospital "Dr. Ignacio Morones Prieto ", with a suspected diagnosis of nickel allergic contact dermatitis, were invited to participate in this study. Later, the objective and methodology of the study were explained to them, as well as the advantages of participating and the possible undesirable effects. All patients signed the informed consent previous perfom the medical history. After, the epicutaneous patch test was performed, and patients were divided according to the result them. Finally, under local anesthesia, two 3-mm punch biopsies, from lesional (positive parch test site) and adjacent non lesional skin, 10 cm apart, were performed. Tissues for reverse transcriptase real-time polymerase chain reaction (RT-qPCR) analyses were stored frozen in sterile tubes at 80ºC until processing

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Conditions studied

  • Allergic Contact Dermatitis

Keywords

  • allergic contact dermatitis
  • nickel
  • microRNAs
  • VCAM-1
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In context

Dermatitis

1,435 studies on the registry are indexed under Dermatitis; 131 are open to participants now.

This study's enrollment of 15 is below the median of 100 across 232 observational studies indexed under Dermatitis.

Browse Dermatitis studies →

Lead sponsor

Universidad Autonoma de San Luis Potosí is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Female and male patients with allergic contact dermatitis for more than one year

Inclusion criteria

  • 18 years of age and older
  • Epicutaneous Patch Test positive to Nickel
  • without previous treatment within the previous 4 weeks

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • nursing
  • menopause
  • consumption of any type of drugs (including anti-inflammatories and hormonal treatments) within the previous 2 months
  • coexistence of other dermatoses conditions
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
15 participants (actual)
Target follow-up
9 Months
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • positive ACD to nickel

    Patients with positive epicutaneous patch test to nickel

  • negative ACD to nickel

    Patients with negative epicutaneous patch test to nickel

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What researchers measure

Primary outcomes

  1. Expression of miR-126

    Relative expression of the miR-126 on skin biopsies from ACD patients

    Time frame: 9 months

07

Study locations

1 site
  • Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
    San Luis Potosí, 78210, Mexico
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References and documents

Publications

  • Martins LE, Reis VM. Immunopathology of allergic contact dermatitis. An Bras Dermatol. 2011 May-Jun;86(3):419-33. doi: 10.1590/s0365-05962011000300001. English, Portuguese. PubMed 21738956 ↗
  • Ahlstrom MG, Thyssen JP, Wennervaldt M, Menne T, Johansen JD. Nickel allergy and allergic contact dermatitis: A clinical review of immunology, epidemiology, exposure, and treatment. Contact Dermatitis. 2019 Oct;81(4):227-241. doi: 10.1111/cod.13327. Epub 2019 Jul 9. PubMed 31140194 ↗
  • Cerutti C, Edwards LJ, de Vries HE, Sharrack B, Male DK, Romero IA. MiR-126 and miR-126* regulate shear-resistant firm leukocyte adhesion to human brain endothelium. Sci Rep. 2017 Mar 30;7:45284. doi: 10.1038/srep45284. PubMed 28358058 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04365140
Lead sponsor
Universidad Autonoma de San Luis Potosí
Responsible party
Juan Pablo Castanedo-Cazares (Adjunt professor, Universidad Autonoma de San Luis Potosí) — Principal investigator
First posted
Apr 28, 2020
Start date
Mar 1, 2019
Primary completion
Nov 1, 2019
Completion
Nov 30, 2019
Last update
Apr 29, 2020

Study contacts

Juan P Castanedo-Cazares, MD
principal investigator · Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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