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Phototherapy: Not a Cause of Demodicosis

The Effect of Phototherapy on Demodex Density: A Case-Control Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06000189
Enrollment
60
Registered
2023-08-21
Start date
2023-05-01
Completion date
2023-08-30
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Demodicidosis

Keywords

Demodex, phototherapy, NBUVB, demodicosis, immunsupression

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.

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.

Interventions

PROCEDUREStandardized 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.

Sponsors

Istanbul Medeniyet University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

Inclusion criteria

* Participants who received phototherapy for various dermatological indications

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Phototherapy: Not a Cause of Demodicosis4 monthsA 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026