Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04365140
Other study ID # ACDm126
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date November 30, 2019

Study information

Verified date April 2020
Source Universidad Autonoma de San Luis Potosí
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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 80ÂșC until processing


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date November 30, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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


Locations

Country Name City State
Mexico Dermatology Department. Hospital Central "Dr. Ignacio Morones Prieto" San Luis Potosí

Sponsors (1)

Lead Sponsor Collaborator
Universidad Autonoma de San Luis Potosí

Country where clinical trial is conducted

Mexico, 

References & Publications (3)

Ahlström MG, Thyssen JP, Wennervaldt M, Menné 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. Review. — View 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. — View Citation

Martins LE, Reis VM. Immunopathology of allergic contact dermatitis. An Bras Dermatol. 2011 May-Jun;86(3):419-33. English, Portuguese. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Expression of miR-126 Relative expression of the miR-126 on skin biopsies from ACD patients 9 months
See also
  Status Clinical Trial Phase
Completed NCT03945760 - Efficacy of Baricitinib In Treatment of Delayed-Type Hypersensitivity Versus Irritant Skin Reactions in Healthy Adult Male Subjects Early Phase 1
Not yet recruiting NCT05498467 - The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis Phase 3
Active, not recruiting NCT03680131 - Evaluation of EB01 Cream for the Treatment of Chronic Allergic Contact Dermatitis Phase 2
Recruiting NCT05535738 - Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation Phase 2/Phase 3
Recruiting NCT06191627 - Patient Experience and Quality of Patch Testing on the Legs vs Back N/A
Completed NCT00867607 - Safety, Tolerability, and Efficacy of 21 Days Dermal Application of MRX-6 on Mild to Moderate Contact Dermatitis Phase 1/Phase 2
Recruiting NCT00445029 - Pathophysiological Study of Allergic Contact Dermatitis to Para-Phenylenediamine (PPD). Analysis of Cellular and Molecular Targets in Skin Inflammation N/A
Recruiting NCT05991674 - A Prospective Study to Investigate Contact Sensitization Using Classic and Machine Learning Techniques
Completed NCT00931242 - Study of Apremilast in Atopic or Contact Dermatitis Phase 2
Completed NCT01798589 - Bioequivalence of Ethylenediamine Dihydrochloride Study Phase 4
Completed NCT01546298 - Immune Reactions in Contact Dermatitis Affected Skin
Completed NCT05339750 - Allergy Skin Patch Artificial Intelligence (AI) N/A
Recruiting NCT03935971 - The Effects of Dupilumab on Allergic Contact Dermatitis Phase 4
Completed NCT01797562 - Clinical Evaluation of T.R.U.E. Test Allergens in Children an Adolescents N/A
Not yet recruiting NCT05858723 - Repeated Open Application Test (ROAT) Study With Hydroperoxides of Linalool N/A
Completed NCT02534441 - Epidemiology and Co-Reactivity of Novel Surfactant Allergens N/A
Not yet recruiting NCT01413477 - Nickel Desensitization Using Topical Therapy N/A
Completed NCT00133341 - Clinical Evaluation of the 3 Allergens: Methyldibromoglutharonitrile, Parthenolide and Goldnatriumthiosulphate Phase 2
Completed NCT00132600 - Clinical Evaluation of Bacitracin Phase 2
Completed NCT03902392 - Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis N/A