DemodicidosisNCT05954572
Association Between Biologic Therapy and Demodex Density in Psoriasis Patients: A Comparative Study
An observational study of Demodicidosis, run by Hasan Aksoy at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Demodicidosis
- What is being tested?
- standardized skin surface biopsy (SSSB)
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2023to 14 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: psoriasis patients aged between 18 and 70 which are diagnosed pathologically or clinically receiving biologic therapy or topical therapy .
Who may be able to join
- pathologically or clinically diagnosed psoriasis patients receiving biologic therapy or topical therapy or treatment naive.
Who cannot join
- systemic therapy other then biologic agents including methotrexate, asitretin, cyclosporin etc.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul Medeniyet University
Istanbul, Kadıköy, 34720
hasan aksoy, +90 505 300 54 60, haxoil@yahoo.com
öykü gönüllü, +90 536 373 8100, oykugonullu@gmail.com
About this study
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.
Read the 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.
- Conditions
- Demodicidosis
- Being tested
- standardized skin surface biopsy (SSSB)
- Keywords
- demodicosis, demodex, psoriasis, biologic therapy, immunosupression
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized skin surface biopsy (SSSB)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: standardized skin surface biopsy (SSSB) | |
| 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. Receives: Diagnostic Test: standardized skin surface biopsy (SSSB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The standardized skin surface biopsy (SSSB) technique
measuring demodex intensity per cm² by applying the technique on four side of the face in both biologic therapy receiving group and control group.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start14 Jul 2023
- Primary completion14 Aug 2023 (estimated)
- Study completion14 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasan Aksoy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hasan Aksoy, Istanbul Medeniyet University
- Investigators
- hasan aksoy, Principal investigator, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954572
- Sponsor's protocol ID
- 939951438
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Keles H, Pancar Yuksel E, Aydin F, Senturk N. Pre-Treatment and Post-Treatment Demodex Densities in Patients under Immunosuppressive Treatments. Medicina (Kaunas). 2020 Mar 3;56(3):107. doi: 10.3390/medicina56030107.
PubMed 32138191Gazi U, Taylan-Ozkan A, Mumcuoglu KY. Immune mechanisms in human and canine demodicosis: A review. Parasite Immunol. 2019 Dec;41(12):e12673. doi: 10.1111/pim.12673. Epub 2019 Oct 8.
PubMed 31557333Marquardt-Feszler A, Cekala K, Debska-Slizien A, Imko-Walczuk B. Demodicosis among immunocompromised patients: a review. Postepy Dermatol Alergol. 2022 Oct;39(5):829-837. doi: 10.5114/ada.2022.120879. Epub 2022 Nov 9.
PubMed 36457664Forton FMN, De Maertelaer V. Which factors influence Demodex proliferation? A retrospective pilot study highlighting a possible role of subtle immune variations and sebaceous gland status. J Dermatol. 2021 Aug;48(8):1210-1220. doi: 10.1111/1346-8138.15910. Epub 2021 May 9.
PubMed 33969532Georgala S, Katoulis AC, Kylafis GD, Koumantaki-Mathioudaki E, Georgala C, Aroni K. Increased density of Demodex folliculorum and evidence of delayed hypersensitivity reaction in subjects with papulopustular rosacea. J Eur Acad Dermatol Venereol. 2001 Sep;15(5):441-4. doi: 10.1046/j.1468-3083.2001.00331.x.
PubMed 11763386Pappu R, Ramirez-Carrozzi V, Sambandam A. The interleukin-17 cytokine family: critical players in host defence and inflammatory diseases. Immunology. 2011 Sep;134(1):8-16. doi: 10.1111/j.1365-2567.2011.03465.x. Epub 2011 Jul 4.
PubMed 21726218
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Biologic Therapy and Demodex Density in Psoriasis Patients: A Comparative Study
- ClinicalTrials.gov ID
- NCT05954572
- Acronym / sponsor ID
- 939951438
- Conditions
- Demodicidosis
- Keywords
- demodicosis, demodex, psoriasis, biologic therapy, immunosupression
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hasan AksoyUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- 14 Aug 2023 (estimated)
- Study completion
- 14 Aug 2023 (estimated)
- First posted
- 20 Jul 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 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psoriasis patients receiving biologic therapy | – | Diagnostic Test: standardized skin surface biopsy (SSSB)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. |
| treatment-naive or topically treated psoriasis patients | – | Diagnostic Test: standardized skin surface biopsy (SSSB)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- psoriasis patients aged between 18 and 70 which are diagnosed pathologically or clinically receiving biologic therapy or topical therapy .
Key inclusion criteria (1 listed)
- pathologically or clinically diagnosed psoriasis patients receiving biologic therapy or topical therapy or treatment naive.
Key exclusion criteria (1 listed)
- systemic therapy other then biologic agents including methotrexate, asitretin, cyclosporin etc.
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 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. | Diagnostic test | psoriasis patients receiving biologic therapy, treatment-naive or topically treated psoriasis patients |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Results publication: PubMed 32138191Keles H, Pancar Yuksel E, Aydin F, Senturk N. Pre-Treatment and Post-Treatment Demodex Densities in Patients under Immunosuppressive Treatments. Medicina (Kaunas). 2020 Mar 3;56(3):107. doi: 10.3390/medicina56030107.
- Results publication: PubMed 31557333Gazi U, Taylan-Ozkan A, Mumcuoglu KY. Immune mechanisms in human and canine demodicosis: A review. Parasite Immunol. 2019 Dec;41(12):e12673. doi: 10.1111/pim.12673. Epub 2019 Oct 8.
- Results publication: PubMed 36457664Marquardt-Feszler A, Cekala K, Debska-Slizien A, Imko-Walczuk B. Demodicosis among immunocompromised patients: a review. Postepy Dermatol Alergol. 2022 Oct;39(5):829-837. doi: 10.5114/ada.2022.120879. Epub 2022 Nov 9.
- Results publication: PubMed 33969532Forton FMN, De Maertelaer V. Which factors influence Demodex proliferation? A retrospective pilot study highlighting a possible role of subtle immune variations and sebaceous gland status. J Dermatol. 2021 Aug;48(8):1210-1220. doi: 10.1111/1346-8138.15910. Epub 2021 May 9.
- Results publication: PubMed 11763386Georgala S, Katoulis AC, Kylafis GD, Koumantaki-Mathioudaki E, Georgala C, Aroni K. Increased density of Demodex folliculorum and evidence of delayed hypersensitivity reaction in subjects with papulopustular rosacea. J Eur Acad Dermatol Venereol. 2001 Sep;15(5):441-4. doi: 10.1046/j.1468-3083.2001.00331.x.
- Results publication: PubMed 21726218Pappu R, Ramirez-Carrozzi V, Sambandam A. The interleukin-17 cytokine family: critical players in host defence and inflammatory diseases. Immunology. 2011 Sep;134(1):8-16. doi: 10.1111/j.1365-2567.2011.03465.x. Epub 2011 Jul 4.
- 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.
hasan aksoy principal investigator
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 Hasan Aksoy 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 20 Jul 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?
Contact hasan aksoy (+90 505 300 54 60, haxoil@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The standardized skin surface biopsy (SSSB) technique (time frame: 1 month). 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 NCT05954572, which also lists 6 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 20 Jul 2023.