AcneNCT07845149
Demodex Mites in Acne Patients and Herbal Extract Susceptibility
An observational study of Acne and Demodex Infestation, run by Assiut University.
Trial summary
This case-control study aims to detect the presence and density of Demodex mites in patients with acne, identify the species using molecular methods, and evaluate the in vitro survival time of live mites exposed to medicinal herbal extracts. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Demodex Infestation
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 26 Sep 2026to 10 Feb 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult patients with clinically diagnosed acne vulgaris attending the dermatology outpatient clinic at Assiut University Hospital, and age- and sex-matched healthy controls.
Who may be able to join
- - Age 18 to 45 years
- Clinically diagnosed acne vulgaris of any severity (cases)
- Age- and sex-matched healthy individuals without dermatosis or pruritus (controls)
- Written informed consent
Who cannot join
- - Use of topical anti-acne or acaricidal treatments within the last 4 weeks
- Use of systemic antibiotics or systemic retinoids within the last 3 months
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Detection and Molecular Identification of Demodex Species in Acne Patients and Its In Vitro Susceptibility to Some Medicinal Herbal Extracts
This case-control study aims to detect the presence and density of Demodex mites in patients with acne, identify the species using molecular methods, and evaluate the in vitro survival time of live mites exposed to medicinal herbal extracts.
Read the detailed description
Demodex mites may contribute to treatment-resistant acne. This observational study will include patients with clinically diagnosed acne and age- and sex-matched healthy controls.
Skin samples will be collected using standardized skin surface biopsy. Mite density will be calculated microscopically, species will be identified by PCR, and live mites will be exposed to different concentrations of medicinal herbal extracts to determine survival time.
- Conditions
- Acne, Demodex Infestation
- Keywords
- Acne, Assiut, In vitro susceptibility, Demodex, Herbal extracts
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Acne | Patients with clinically diagnosed acne of any severity (mild, moderate, or severe) who will undergo standardized skin surface biopsy for Demodex detection and density calculation. | |
| Healthy Controls | Age- and sex-matched healthy individuals without dermatosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Demodex infestation
Proportion of participants with Demodex mites detected by standardized skin surface biopsy.
Measured: Baseline
Mean Demodex density
Mean number of Demodex mites per cm² of skin surface.
Measured: Baseline
Mean in vitro survival time of Demodex mites
Mean survival time in minutes of live Demodex mites exposed to the medicinal herbal extracts.
Measured: Baseline
Secondary outcomes (6)
Distribution of Demodex species
Frequency and percentage of Demodex folliculorum and Demodex brevis among positive cases identified by PCR.
Measured: Baseline
Mean mite density according to acne severity
Mean Demodex density (mites/cm²) in mild, moderate, and severe acne groups according to the Global Acne Grading System.
Measured: Baseline
Mean survival time at 5% herbal extract concentration
Mean survival time in minutes of Demodex mites exposed to 5% concentration of the herbal extract
Measured: Baseline
Mean survival time at 10% herbal extract concentration
Mean survival time in minutes of Demodex mites exposed to 10% concentration of the herbal extract.
Measured: Baseline
Mean survival time at 25% herbal extract concentration
Mean survival time in minutes of Demodex mites exposed to 25% concentration of the herbal extract.
Measured: Baseline
Mean survival time at 50% herbal extract concentration
Mean survival time in minutes of Demodex mites exposed to 50% concentration of the herbal extract
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start26 Sep 2026 (estimated)
- Primary completion26 Sep 2027 (estimated)
- Study completion10 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Gamil Shawqi, Assiut University
- Investigators
- Magda M Atiaa, prof, Study chair, Medical parasitology Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845149
- Sponsor's protocol ID
- Demodex-Acne-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection and Molecular Identification of Demodex Species in Acne Patients and Its In Vitro Susceptibility to Some Medicinal Herbal Extracts
- ClinicalTrials.gov ID
- NCT07845149
- Acronym / sponsor ID
- Demodex-Acne-Assiut-2026
- Conditions
- Acne, Demodex Infestation
- Keywords
- Acne, Assiut, In vitro susceptibility, Demodex, Herbal extracts
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 26 Sep 2027 (estimated)
- Study completion
- 10 Feb 2028 (estimated)
- First posted
- 28 Sep 2026 (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.
This case-control study aims to detect the presence and density of Demodex mites in patients with acne, identify the species using molecular methods, and evaluate the in vitro survival time of live mites exposed to medicinal herbal extracts.
Detailed description
Demodex mites may contribute to treatment-resistant acne. This observational study will include patients with clinically diagnosed acne and age- and sex-matched healthy controls.
Skin samples will be collected using standardized skin surface biopsy. Mite density will be calculated microscopically, species will be identified by PCR, and live mites will be exposed to different concentrations of medicinal herbal extracts to determine survival time.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Acne | – | –Patients with clinically diagnosed acne of any severity (mild, moderate, or severe) who will undergo standardized skin surface biopsy for Demodex detection and density calculation. |
| Healthy Controls | – | –Age- and sex-matched healthy individuals without dermatosis. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult patients with clinically diagnosed acne vulgaris attending the dermatology outpatient clinic at Assiut University Hospital, and age- and sex-matched healthy controls.
Key inclusion criteria (4 listed)
- - Age 18 to 45 years
- Clinically diagnosed acne vulgaris of any severity (cases)
- Age- and sex-matched healthy individuals without dermatosis or pruritus (controls)
- Written informed consent
Key exclusion criteria (2 listed)
- - Use of topical anti-acne or acaricidal treatments within the last 4 weeks
- Use of systemic antibiotics or systemic retinoids within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Demodex infestation
Time frame: Baseline
Proportion of participants with Demodex mites detected by standardized skin surface biopsy.
Mean Demodex density
Time frame: Baseline
Mean number of Demodex mites per cm² of skin surface.
Mean in vitro survival time of Demodex mites
Time frame: Baseline
Mean survival time in minutes of live Demodex mites exposed to the medicinal herbal extracts.
6 secondary outcomes
Distribution of Demodex species
Time frame: Baseline
Mean mite density according to acne severity
Time frame: Baseline
Mean survival time at 5% herbal extract concentration
Time frame: Baseline
Mean survival time at 10% herbal extract concentration
Time frame: Baseline
Mean survival time at 25% herbal extract concentration
Time frame: Baseline
Mean survival time at 50% herbal extract concentration
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Magda M Atiaa, prof study chair
Medical parasitology Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Acne and Demodex Infestation, run by Assiut University.
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 4 inclusion and 2 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marina G shawqy, Resident (+20 12 76121351, Marina.gamil@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Demodex infestation (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026.