Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2023-05-01
2023-08-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Istanbul Medeniyet University
OTHER
Responsible Party
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Hasan Aksoy
Medical Doctor
Principal Investigators
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Melek Aslan Kayıran, Ass.Prof
Role: STUDY_CHAIR
Istanbul Medeniyet University
sümeyye Altıntaş Kakşi, Specialist
Role: STUDY_CHAIR
Istanbul Medeniyet University
Vefa Aslı Erdemir, Prof
Role: STUDY_CHAIR
Istanbul Medeniyet University
Yeşim Dede, Resident
Role: STUDY_CHAIR
Istanbul Medeniyet University
Locations
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Istanbul Medeniyet University
Istanbul, Kadıköy, Turkey (Türkiye)
Countries
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References
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Turkmen D, Turkoglu G. Demodex Infestation in Patients with Rosacea. Turkiye Parazitol Derg. 2019 Dec 23;43(4):194-197. doi: 10.4274/tpd.galenos.2019.6456.
Kulac M, Ciftci IH, Karaca S, Cetinkaya Z. Clinical importance of Demodex folliculorum in patients receiving phototherapy. Int J Dermatol. 2008 Jan;47(1):72-7. doi: 10.1111/j.1365-4632.2007.03336.x.
Forton F, Seys B. Density of Demodex folliculorum in rosacea: a case-control study using standardized skin-surface biopsy. Br J Dermatol. 1993 Jun;128(6):650-9. doi: 10.1111/j.1365-2133.1993.tb00261.x.
Aytekin S. Outbreak of demodex folliculitis on the face and upper trunk during 311-nm UVB therapy for psoriasis. J Eur Acad Dermatol Venereol. 2004 Mar;18(2):236-8. doi: 10.1111/j.1468-3083.2004.00898.x. No abstract available.
Other Identifiers
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2022/0340
Identifier Type: -
Identifier Source: org_study_id
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