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NCT Number: NCT07817277

Hair Changes in Females With Type 2 Diabetes Clinical and Trichoscopic Examination

The aim of this thesis is to investigate the effect of diabetes mellitus on hair by assessing and comparing clinical and dermoscopic hair changes in diabetic patients versus age and sex-matched healthy controls.

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Key information

Age range

20 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Al Zahraa hospital

Cairo, Cairo Governorate, Egypt

About this study

The patients will be recruited from the dermatology and endocrinology outpatient clinics of Al-Zahraa University Hospital.

Inclusion criteria

Cases:

Female patients aged 20-60 years Diagnosed with type 2 diabetes mellitus for at least 1 year HbA1c ≥ 6.5% o Consent to participate

  • Controls:

Age-matched healthy females (no history of diabetes or insulin resistance) Normal fasting blood sugar (<100 mg/dL) and HbA1c (<5.7%) No known chronic illness Consent to participate Exclusion Criteria (for both groups)

  • Current pregnancy or lactation
  • Thyroid dysfunction
  • Polycystic ovary syndrome (PCOS) • Anemia (Hb < 10 g/dL)
  • History of chemotherapy, radiotherapy, or recent acute illness
  • Scalp diseases (e.g., tinea capitis, scarring alopecia)
  • Recent use of drugs known to affect hair growth (e.g., isotretinoin, spironolactone)

All patients and control will undergo:

  • Full history taking 2. Clinical Assessment All participants will undergo generalized dermatological examination including the scalp and body hair. The following aspects will be documented: A. General Scalp Examination • Hair density: visual inspection (reduced, normal) • Scalp condition: erythema, scaling, atrophy, scarring • Presence of inflammation or follicular hyperkeratosis • Hair shaft fragility or breakage • Sebum level: dry, normal, oily

B. Hair Loss Type Classification Hair loss will be clinically categorized into one of the following types:

  • Telogen effluvium (TE) Diffuse shedding, positive hair pull test
  • Female pattern hair loss (FPHL) Frontal or vertex thinning with preserved frontal hairline
  • Alopecia areata (AA) Patches of non-scarring alopecia
  • Chronic diffuse hair loss Shedding >6 months without clear pattern C. Hair Pull Test • Performed by grasping ~50 hairs from the frontal, parietal, and occipital regions • Considered positive if >6 hairs are easily extracted • Helps diagnose active shedding, especially in TE 3. Dermoscopic (Trichoscopic) Assessment Dermoscopy will be performed using a handheld dermoscope ( dermasight DS175 -cutechs LLC, Cairo, Egypt ) at 10× magnification, with or without immersion fluid.

A. Sites Examined

  • Frontal scalp (midline, 2 cm behind hairline)
  • Vertex
  • Occipital region (serves as internal control)

Each site will be examined systematically, and the following features will be documented:

B. Dermoscopic Parameters Hair shaft diameter diversity (HSDD) >20% variation Yellow dots Peripilar signs (brown halos) Short vellus hairs Thin hairs <30 μm Empty follicular openings Black dots Exclamation mark hairs Broken / dystrophic hairs

  • Blinding and Reproducibility
  • Two independent dermatologists will assess dermoscopic images. • In case of disagreement, a third reviewer will be consulted. • Observers will be blinded to diabetic status to minimize bias.
  • Photographic Documentation • High-resolution digital images of scalp regions 6. Laboratory investigations:

The following laboratory serum tests will be done:

  • Complete blood count.
  • serum ferritin.
  • Thyroid stimulating hormone.
  • serum vitamin D3.
  • Erythrocyte sedimentation rate.
  • Glycated hemoglobin.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cases:
  • Female patients aged 20-60 years
  • Diagnosed with type 2 diabetes mellitus for at least 1 year
  • HbA1c ≥ 6.5% o Consent to participate
  • Controls:
  • Age-matched healthy females (no history of diabetes or insulin resistance)
  • Normal fasting blood sugar (<100 mg/dL) and HbA1c (<5.7%) o No known chronic illness
  • Consent to participate

Exclusion criteria

  • Current pregnancy or lactation
  • Thyroid dysfunction • Polycystic ovary syndrome (PCOS)
  • Anemia (Hb < 10 g/dL)
  • History of chemotherapy, radiotherapy, or recent acute illness
  • Scalp diseases (e.g., tinea capitis, scarring alopecia)
  • Recent use of drugs known to affect hair growth (e.g., isotretinoin, spironolactone)

Treatment and study plan

Primary outcomes

  1. Evaluation of Hair Changes in Female Patients with Type 2 Diabetes Mellitus Versus Non-Diabetic Controls: A Clinical and Dermoscopic Cross-Sectional Study

    Time frame: 1 year

    Clinical Hair Assessment:

    • Hair loss pattern (diffuse, frontal, vertex, etc.)
    • Duration of hair loss (months/years)
    • Hair pull test results (positive/negative)

    Dermoscopic (Trichoscopic) Features:

    • Hair shaft diameter variability (%)
    • Presence of yellow dots, white dots, or peripilar signs
    • Follicular density (number/cm²)
    • Miniaturized hair count

    Metabolic and Laboratory Parameters:

    • BMI (kg/m²)
    • HbA1c (%)
    • Serum Ferritin (ng/mL)
    • Vitamin D3 (ng/mL)
    • TSH (µIU/mL)
    • Hemoglobin (g/dL)
    • ESR (mm/hr)

    Diabetes-Related Measures:

    • Duration of diabetes (years)
    • Presence of diabetic neuropathy (yes/no)

    Patient-Reported Outcomes

    Visual Analog Scale (VAS) for hair loss severity (ludwing scale-sinclair scale)

    Physician's Global Assessment of hair changes

Study contacts

Contact information is provided by the study sponsor or research team.

Heba khaled younes, resident

CONTACT

[email protected]

+201025858377

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Evaluation of Hair Changes in Female Patients With Type2 Diabetes Mellitus Versus Non-Diabetic Controls :A Clinical and Dermoscopic Cross-Sectional Study

Acronym: TrichoscopyDM2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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