Clinical trial NCT04365140: MicroRNA-126 and Its Target VCAM-1Dermatitis to Nickel
Official title: Alteration of the microRNA-126 Expression: a Possible Mechanism in Allergic Contact Dermatitis to Nickel
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Contact Dermatitis
Keywords: allergic contact dermatitis
nickel
microRNAs
VCAM-1
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female and male patients with allergic contact dermatitis for more than one year

Brief 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Expression of miR-126
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Potosí
country: Mexico
facility: Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
Study officials:
affiliation: Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"
name: Juan P Castanedo-Cazares, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.