DemodicidosisNCT06000189
Phototherapy: Not a Cause of Demodicosis
An observational study of Demodicidosis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Demodicidosis
- What is being tested?
- Standardized skin surface biopsies (SSSB)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 30 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Participants aged between 18 and 65 which are received narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy for various dermatological indications
Who may be able to join
- Participants who received phototherapy for various dermatological indications
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medeniyet University
Istanbul, Kadıköy, 34720
About this study
Official title: The Effect of Phototherapy on Demodex Density: A Case-Control Study
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.
Read the 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.
- Conditions
- Demodicidosis
- Being tested
- Standardized skin surface biopsies (SSSB)
- Keywords
- Demodex, phototherapy, NBUVB, demodicosis, immunsupression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized skin surface biopsies (SSSB)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Standardized skin surface biopsies (SSSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phototherapy: Not a Cause of Demodicosis
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 May 2023
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DemodicidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasan Aksoy, Istanbul Medeniyet University
- Investigators
- Melek Aslan Kayıran, Ass.Prof, Study chair, Istanbul Medeniyet Universitysümeyye Altıntaş Kakşi, Specialist, Study chair, Istanbul Medeniyet UniversityVefa Aslı Erdemir, Prof, Study chair, Istanbul Medeniyet UniversityYeşim Dede, Resident, Study chair, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000189
- Sponsor's protocol ID
- 2022/0340
- Status last verified
- Aug 2023
- First submitted
- 28 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31865655Kulac 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.
PubMed 18173609Forton 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.
PubMed 8338749Aytekin 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.
PubMed 15009323
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Phototherapy on Demodex Density: A Case-Control Study
- ClinicalTrials.gov ID
- NCT06000189
- Acronym / sponsor ID
- 2022/0340
- Conditions
- Demodicidosis
- Keywords
- Demodex, phototherapy, NBUVB, demodicosis, immunsupression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants who received phototherapy for various dermatological indications | – | Procedure: Standardized skin surface biopsies (SSSB)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants aged between 18 and 65 which are received narrow-band ultraviolet B (NBUVB) or ultraviolet A-1 (UVA-1) therapy for various dermatological indications
Key inclusion criteria (1 listed)
- Participants who received phototherapy for various dermatological indications
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Participants who received phototherapy for various dermatological indications |
Primary outcome
Phototherapy: Not a Cause of Demodicosis
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Results publication: PubMed 31865655Turkmen 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.
- Results publication: PubMed 18173609Kulac 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.
- Results publication: PubMed 8338749Forton 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.
- Results publication: PubMed 15009323Aytekin 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melek Aslan Kayıran, Ass.Prof study chair
Istanbul Medeniyet University
sümeyye Altıntaş Kakşi, Specialist study chair
Istanbul Medeniyet University
Vefa Aslı Erdemir, Prof study chair
Istanbul Medeniyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Demodicidosis, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phototherapy: Not a Cause of Demodicosis (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000189, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.