Diabete MellitusTrichoscopyDM2NCT07817277
Hair Changes in Females With Type 2 Diabetes Clinical and Trichoscopic Examination
An observational study of Diabete Mellitus and Female Androgenetic Alopecia, run by Al-Azhar University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Diabete Mellitus, Female Androgenetic Alopecia, Dermoscopy
- How many people
- 130 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2026to 1 Mar 2027
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: The patients will be recruited from the dermatology and endocrinology outpatient clinics of Al-Zahraa University Hospital. 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).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Hair Changes in Female Patients With Type2 Diabetes Mellitus Versus Non-Diabetic Controls :A Clinical and Dermoscopic Cross-Sectional Study
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.
Read the 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:
- 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
- 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.
- 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:
- 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.
- Conditions
- Diabete Mellitus, Female Androgenetic Alopecia, Dermoscopy
- Keywords
- Dermoscopy, FPHL, DM2
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Hair Changes in Female Patients with Type 2 Diabetes Mellitus Versus Non-Diabetic Controls: A Clinical and Dermoscopic Cross-Sectional Study
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete MellitusStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Khaled Younes Mohamed, Al-Azhar University
- Investigators
- Basma Alsayed risha, lecturer, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817277
- Sponsor's protocol ID
- 2025072871
- Acronym
- TrichoscopyDM2
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hair Changes in Female Patients With Type2 Diabetes Mellitus Versus Non-Diabetic Controls :A Clinical and Dermoscopic Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07817277
- Acronym / sponsor ID
- TrichoscopyDM2 / 2025072871
- Conditions
- Diabete Mellitus, Female Androgenetic Alopecia, Dermoscopy
- Keywords
- Dermoscopy, FPHL, DM2
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 14 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.
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.
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:
- 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
- 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.
- 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:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The patients will be recruited from the dermatology and endocrinology outpatient clinics of Al-Zahraa University Hospital. 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).
Key inclusion criteria (8 listed)
- Cases:
Key exclusion criteria (6 listed)
- Current pregnancy or lactation
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
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: 1. Hair loss pattern (diffuse, frontal, vertex, etc.) 2. Duration of hair loss (months/years) 3. Hair pull test results (positive/negative) Dermoscopic (Trichoscopic) Features: 1. Hair shaft diameter variability (%) 2. Presence of yellow dots, white dots, or peripilar signs 3. Follicular density (number/cm²) 4. Miniaturized hair count Metabolic and Laboratory Parameters: 1. BMI (kg/m²) 2. HbA1c (%) 3. Serum Ferritin (ng/mL) 4. Vitamin D3 (ng/mL) 5. TSH (µIU/mL) 6. Hemoglobin (g/dL) 7. ESR (mm/hr) Diabetes-Related Measures: 1. Duration of diabetes (years) 2. 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
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 14 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Diabete Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Basma Alsayed risha, lecturer principal investigator
Al-Azhar 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 Diabete Mellitus and Female Androgenetic Alopecia, run by Al-Azhar University at 1 site in Egypt.
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 8 inclusion and 6 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 14 Sep 2026. 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 Egypt. 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?
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 Heba khaled younes, resident (+201025858377, drmedhatyoness@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 14 Sep 2026.