Clinical Trial on Diabete Mellitus, Dermoscopy, Female Androgenetic Alopecia - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

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:

1. 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

4. 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.

5. 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.

Study Type

Observational

Enrollment (Estimated)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Heba khaled younes, resident
Phone Number: +201025858377
Email: drmedhatyoness@gmail.com

Study Locations

Egypt
- Cairo Governorate
  - Cairo, Cairo Governorate, Egypt
    - Al Zahraa hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Investigators

Principal Investigator: Basma Alsayed risha, lecturer, Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 4, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)