NCT07845149

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Sep 2026Feb 2028

First Submitted

Initial submission to the registry

September 22, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

September 26, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2028

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

AcneAssiutIn vitro susceptibilityDemodexHerbal extracts

Outcome Measures

Primary Outcomes (3)

  • Prevalence of Demodex infestation

    Proportion of participants with Demodex mites detected by standardized skin surface biopsy.

    Baseline

  • Mean Demodex density

    Mean number of Demodex mites per cm² of skin surface.

    Baseline

  • Mean in vitro survival time of Demodex mites

    Mean survival time in minutes of live Demodex mites exposed to the medicinal herbal extracts.

    Baseline

Secondary Outcomes (6)

  • Distribution of Demodex species

    Baseline

  • Mean mite density according to acne severity

    Baseline

  • Mean survival time at 5% herbal extract concentration

    Baseline

  • Mean survival time at 10% herbal extract concentration

    Baseline

  • Mean survival time at 25% herbal extract concentration

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Study Officials

  • Magda M Atiaa, prof

    Medical parasitology Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Marina G shawqy, Resident

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician, Department of medical Parasitology

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

September 26, 2026

Primary Completion (Estimated)

September 26, 2027

Study Completion (Estimated)

February 10, 2028

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share