Phototherapy: Not a Cause of Demodicosis

Sponsor
Istanbul Medeniyet University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT06000189
Collaborator
(none)
60
1
4
15.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether there is an increase in the frequency of demodicosis and the density of Demodex mites after 20 sessions of phototherapy.

The main question(s)it aims to answer are;

  • Are Demodex mites higher in patients treated with phototherapy?

  • 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 phototherapy effects demodex intensity on patients.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standardized skin surface biopsies (SSSB)

Detailed Description

This study employee as a case-control study to compare the Demodex densities before and after 20 sessions of narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy in patients who will receive phototherapy for any dermatological indication. The study is going to be conducted at Istanbul Medeniyet University Department of Dermatology between June 2023 and August 2023. Ethical approval was obtained from Istanbul Medeniyet University Local Ethics Committee (decision number: 2022/0340).

Demographic and medical information, including age, gender, smoking and alcohol habits, dermatological indication of phototherapy, presence of facial involvement of the relevant disease, and use of medications or cosmetic products on the face in the last week, will be obtained through a standardized form. Patients will be evaluated by the researcher for the presence of clinical conditions associated with primary/secondary demodicosis, such as acne, rosacea, perioral dermatitis, seborrheic dermatitis, folliculitis, blepharitis, or pityriasis folliculorum.

The standardized skin surface biopsy (SSSB) technique is going to be utilized to assess Demodex density. Skin samples will be obtained from four regions of the participants' faces, including the forehead, right cheek, left cheek, and the nose, before phototherapy and after 20 sessions of phototherapy. The SSSB will be performed as follows: a 1 cm² square will be drawn on a glass slide using a ruler. The skin areas to be sampled will be gently swabbed with a dry gauze to induce irritation by this way to obtain more mites. Then, one drop of cyanoacrylate adhesive will be dropped onto the marked area on the glass slide, and the adhesive surface of the slide will be pressed onto the skin surface for approximately one minute. Afterwards, the slide will be gently lifted, and the sampled area will be examined under a light microscope at x10 and x40 magnifications after applying immersion oil. The presence of more than five Demodex mites per square centimeter will be defined as increased Demodex density.

Statistical analysis will be performed using IBM Statistical Package for the Social Sciences [SPSS] v.17. Means, standard deviations, or frequencies will be calculated for relevant variables as required. Paired samples t-test will be used to compare Demodex densities, and the McNemar test will be used to compare the presence of demodicosis between pre- and post-treatment. A p-value of less than 0.05 will be considered statistically significant.

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Effect of Phototherapy on Demodex Density: A Case-Control Study
Actual Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Aug 30, 2023
Anticipated Study Completion Date :
Aug 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Participants who received phototherapy for various dermatological indications

A case-control study will be conducted participants who received narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy for various dermatological indications. Standardized skin surface biopsies (SSSB) were performed before and after phototherapy to assess Demodex density. Demographic data, medical information, and the presence of demodex-related skin conditions were recorded using a standardized form. Statistical analysis will be performed to compare the demodex densities and prevalence of demodicosis between baseline and 20th session of phototherapy.

Procedure: Standardized skin surface biopsies (SSSB)
Skin samples will be obtained from four regions of the participants' faces, including the forehead, right cheek, left cheek, and the nose, before phototherapy and after 20 sessions of phototherapy. The SSSB will be performed as follows: a 1 cm² square will be drawn on a glass slide using a ruler. The skin areas to be sampled will be gently swabbed with a dry gauze to induce irritation by this way to obtain more mites. Then, one drop of cyanoacrylate adhesive will be dropped onto the marked area on the glass slide, and the adhesive surface of the slide will be pressed onto the skin surface for approximately one minute. Afterwards, the slide will be gently lifted, and the sampled area will be examined under a light microscope at x10 and x40 magnifications after applying immersion oil. The presence of more than five Demodex mites per square centimeter will be defined as increased Demodex density.

Outcome Measures

Primary Outcome Measures

  1. Phototherapy: Not a Cause of Demodicosis [4 months]

    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 performed before and after phototherapy to assess Demodex density.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • Participants who received phototherapy for various dermatological indications
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Istanbul Medeniyet University Istanbul Kadıköy Turkey 34720

Sponsors and Collaborators

  • Istanbul Medeniyet University

Investigators

  • Study Chair: Melek Aslan Kayıran, Ass.Prof, Istanbul Medeniyet University
  • Study Chair: sümeyye Altıntaş Kakşi, Specialist, Istanbul Medeniyet University
  • Study Chair: Vefa Aslı Erdemir, Prof, Istanbul Medeniyet University
  • Study Chair: Yeşim Dede, Resident, Istanbul Medeniyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hasan Aksoy, Medical Doctor, Istanbul Medeniyet University
ClinicalTrials.gov Identifier:
NCT06000189
Other Study ID Numbers:
  • 2022/0340
First Posted:
Aug 21, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hasan Aksoy, Medical Doctor, Istanbul Medeniyet University

Study Results

No Results Posted as of Aug 21, 2023