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

Completed

• Conditions: Allergic Contact Dermatitis

• Registration Number: NCT04365140
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

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

Study Timeline

• Study Start: 2019-03-01
• Primary Completion: 2019-11-01
• Study Completion: 2019-11-30
• Status Verified: 2020-04
• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-23
• Last Update Submitted: 2020-04-27
• Study First Posted: 2020-04-28
• Last Update Posted: 2020-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expression of miR-126	9 months	Relative expression of the miR-126 on skin biopsies from ACD patients

Trial Locations

Locations (1)

Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto"; 🇲🇽 San Luis Potosí, Mexico