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Completed

NCT Number: NCT04365140

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, 78210, Mexico

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Primary outcomes

  1. Expression of miR-126

    Time frame: 9 months

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

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de San Luis Potosí

Other

Registry information

Official study title

Alteration of the microRNA-126 Expression: a Possible Mechanism in Allergic Contact Dermatitis to Nickel

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 28, 2020
Registry last updated
Apr 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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