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

July 13, 2023 updated by: Hasan Aksoy

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Kadıköy
      • Istanbul, Kadıköy, Turkey, 34720
        • Recruiting
        • Istanbul Medeniyet University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

psoriasis patients aged between 18 and 70 which are diagnosed pathologically or clinically receiving biologic therapy or topical therapy .

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The standardized skin surface biopsy (SSSB) technique
Time Frame: 1 month
measuring demodex intensity per cm² by applying the technique on four side of the face in both biologic therapy receiving group and control group.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasan Aksoy

Investigators

  • Principal Investigator: hasan aksoy, Istanbul Medeniyet University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Estimated)

August 14, 2023

Study Completion (Estimated)

August 14, 2023

Study Registration Dates

First Submitted

July 13, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 939951438

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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