Clinical Trial Finder

Association Between Biologic Therapy and Demodex Density in Psoriasis Patients: A Comparative Study

Study Purpose

The goal of this observational study is to investigate whether the density of Demodex mites is higher in psoriasis patients treated with biologic agents compared to treatment-naive or topically treated patients. The main question[s]it aims to answer are:

  • - Are Demodex mites higher in psoriasis patients treated with biologic agents? - In which localization and with what intensity was demodicosis most common? Participants will be assessed using standardized skin surface biopsy technique in four localization on their face .
Researchers will compare demodex intensity per cm² to see if the biologic treatments effects demodex intensity on psoriasis patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - pathologically or clinically diagnosed psoriasis patients receiving biologic therapy or topical therapy or treatment naive.

Exclusion Criteria:

- systemic therapy other then biologic agents including methotrexate, asitretin, cyclosporin etc.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05954572
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Hasan Aksoy
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 hasan aksoy
Principal Investigator Affiliation Istanbul Medeniyet University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Turkey
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Demodicidosis
Additional Details

This study employes a cross-sectional design to compare the density of Demodex mites in psoriasis patients receiving biologic therapy and those who had not yet initiated any treatment or were using topical medications only. The study is going to be conducted at Istanbul Medeniyet University Department of Dermatology between July 2023-August 2023. Ethics approval was obtained from Istanbul Medeniyet University Local Ethics Commitee (decision number:2022/0341). A standardized form will be used to collect demographic information, and details regarding smoking and alcohol habits. Additional information regarding their treatment regimens will be recorded. Furthermore, patients will be evaluated for the presence of acne, rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis folicullorum, as these conditions have been associated with an increased Dd. The standardized skin surface biopsy (SSSB) technique is going to be utilized to assess demodicosis. This technique will be applied in four facial localizations, including the forehead, cheeks, and nose. The surface biopsy procedure will be performed as follows: one cm² area will be marked on a glass slide using a fine ruler. The designated skin area for sampling will be gently swabbed with a dry gauze pad to create mild irritation. Subsequently, one drop of cyanoacrylate adhesive will be applied to the marked area on the glass slide. The glass slide will be carefully pressed onto the skin, allowing the adhesive to adhere. After approximately one minute, the glass slide will be gently lifted. The sampled area on the glass slide will be examined under x10 and x40 magnification. Immersion oil will be applied to enhance visualization and determine the number of Demodex parasites within the marked area. An increased Demodicosis will be defined as the presence of five or more Demodex parasites per square centimeter of skin. Statistical analysis will be performed using Statistical Package for the Social Sciences [SPSS] v.17. Descriptive statistics will be calculated for relevant variables, including means, standard deviations, and frequencies. The independent samples t-test will be utilized to compare the Demodex densities, and the Chi-Square test will be used to compare the presence of demodicidosis between the two groups. P-values less than 0.05 will be considered statistically significant.

Arms & Interventions

Arms

: psoriasis patients receiving biologic therapy

A standardized form is going to be used to collect demographic information, and details regarding smoking and alcohol habits. Additional information regarding their treatment regimens will be recorded. Furthermore patients will be evaluated for the presence of acne, rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis folicullorum, as these conditions have been associated with an increased demodicosis. After that the standardized skin surface biopsy (SSSB) technique will be utilized to assess demodicosis.

: treatment-naive or topically treated psoriasis patients

A standardized form is going to be used to collect demographic information, and details regarding smoking and alcohol habits. Additional information regarding their treatment regimens will be recorded. Furthermore patients will be evaluated for the presence of acne, rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis folicullorum, as these conditions have been associated with an increased demodicosis. After that the standardized skin surface biopsy (SSSB) technique will be utilized to assess demodicosis.

Interventions

Diagnostic Test: - standardized skin surface biopsy (SSSB)

This technique is applied in four facial localizations, including the forehead, cheeks, and nose. The surface biopsy procedure is performed as follows: one cm² area was marked on a glass slide using a fine ruler. The designated skin area for sampling is gently swabbed with a dry gauze pad to create mild irritation. Subsequently, one drop of cyanoacrylate adhesive is applied to the marked area on the glass slide. The glass slide is carefully pressed onto the skin, allowing the adhesive to adhere. After approximately one minute, the glass slide is gently lifted. The sampled area on the glass slide is examined under x10 and x40 magnification. Immersion oil is applied to enhance visualization and determine the number of Demodex parasites within the marked area. An increased demodicosis is defined as the presence of five or more Demodex parasites per square centimeter of skin.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Istanbul Medeniyet University, Istanbul, Kadıköy, Turkey

Status

Recruiting

Address

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720

Site Contact

hasan aksoy

haxoil@yahoo.com

+90 505 300 54 60

Powered By

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.