Focal Non-cicatricial AlopeciaNCT03260777
Relevance of Trichoscopy in Differential Diagnosis of Focal Non-cicatricial Alopecia in Children
An observational study of Focal Non-cicatricial Alopecia, run by Assiut University at 1 site in Egypt.
Trial summary
Alopecia is a common, distressing condition that is sometimes difficult to diagnose and treat. Losing hair is not usually health threatening; it can scar a young child's vulnerable self-esteem by causing immense psychological and emotional stress, not only to the patient, but also to the concerned parents and… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Focal Non-cicatricial Alopecia
- What is being tested?
- Trichoscopy
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Nov 2017to 1 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 100 Patients with focal non-cicatricial alopecia will be recruited from the outpatient clinic of Dermatology , Venereology and Andrology department at Assiut University Hospital
Who may be able to join
- -age from 3-18 years of both sexes with focal non-cicatricial alopecia.(1-5 patches of alopecia)
Who cannot join
- Patients who will not consent.
- uncooperative children.
- patients with active secondary bacterial infection in the alopecic patch.
- patients with any concomitant dermatological diseases.
- history of using any topical(1 month) or systemic treatment (3 month) for tinea capitis or alopecia areata prior to the study,
- cicatricial alopecia.
Trial locations and contacts
1 site in 1 country.
About this study
Alopecia is a common, distressing condition that is sometimes difficult to diagnose and treat.
Losing hair is not usually health threatening; it can scar a young child's vulnerable self-esteem by causing immense psychological and emotional stress, not only to the patient, but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed and treated early to overcome the resulting problems.
Read the detailed description
The majority of alopecia in children is presented as patchy alopecia, which is most commonly diagnosed as alopecia areata. However, other causes of patchy alopecia such as tinea capitis, trichotillomania, temporal triangular alopecia (TTA), nevus sebaceous and aplasia cutis congenita (ACC) can be easily missed.
Trichoscopy (hair and scalp dermoscopy) is a non-invasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye.
Trichoscopy allows visualization of hair shafts at high magnification and performing measurements, such as hair shaft thickness, without the need of removing hair for diagnostic purposes. It also allows in vivo visualization of the epidermal portion of hair follicles and perifollicular epidermis.
The advantages of trichoscopy in evaluating hair loss in children are numerous, as it is a fast in-office technique , non-invasive, inexpensive, and painless , and therefore it will be accepted by children and their parents.
Tinea capitis and alopecia areata are considered to be the most common causes of hairless patches of the scalp in pediatrics. Tinea capitis especially non-scaly type may have the same clinical appearance of alopecia areata, so trichoscopy has recently become a useful diagnostic tool for alopecia areata and tinea capitis, especially in doubtful cases as lab investigations like fungal culture or biopsy may take several weeks.
- Conditions
- Focal Non-cicatricial Alopecia
- Being tested
- Trichoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrichoscopyDevice
Trichoscopy (hair and scalp dermoscopy) is a noninvasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye Structures which may be visualized by trichoscopy include hair shafts of different types, the number of hairs in one pilosebaceous unit, hair follicle openings (dots), the peri and interfollicular areas and the vasculature.
| Study group | Role | What they receive |
|---|---|---|
| children with Alopecia Areata | Not described Receives: Device: Trichoscopy | |
| children with tinea capitis | Not described Receives: Device: Trichoscopy | |
| children with trichotillomania | Not described Receives: Device: Trichoscopy | |
| children with tractional alopecia | Not described Receives: Device: Trichoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of the common trichoscopic findings in diagnosis of clinically difficult cases of focal non-cicatricial alopecia in children.
Characteristic trichoscopic findings will be searched for in each case such as (exclamation mark hairs, yellow and black dots) for alopecia areata. Flame hairs, tulip hairs, coiled hairs, hook hairs, v-sign and irregularly broken hairs for trichotillomania.Findings for tinea capitis (comma hairs, zigzag hairs, corkscrew hairs and block hairs).Coiled irregularly broken hairs and hair casts for tractional alopecia.
Measured: 2017-2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start18 Nov 2017
- Primary completion1 Sep 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Focal Non-cicatricial AlopeciaStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260777
- Sponsor's protocol ID
- ROTIDDOFNCAIC
- Status last verified
- Jan 2021
- First submitted
- 21 Aug 2017
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lencastre A, Tosti A. Role of trichoscopy in children's scalp and hair disorders. Pediatr Dermatol. 2013 Nov-Dec;30(6):674-82. doi: 10.1111/pde.12173. Epub 2013 Aug 13.
PubMed 23937326Miteva M, Tosti A. Hair and scalp dermatoscopy. J Am Acad Dermatol. 2012 Nov;67(5):1040-8. doi: 10.1016/j.jaad.2012.02.013. Epub 2012 Mar 8.
PubMed 22405573Sarifakioglu E, Yilmaz AE, Gorpelioglu C, Orun E. Prevalence of scalp disorders and hair loss in children. Cutis. 2012 Nov;90(5):225-9.
PubMed 23270190Rakowska A. Trichoscopy (hair and scalp videodermoscopy) in the healthy female. Method standardization and norms for measurable parameters. J Dermatol Case Rep. 2009 Apr 5;3(1):14-9. doi: 10.3315/jdcr.2008.1021.
PubMed 21886722Hillmann K, Blume-Peytavi U. Diagnosis of hair disorders. Semin Cutan Med Surg. 2009 Mar;28(1):33-8. doi: 10.1016/j.sder.2008.12.005.
PubMed 19341940
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relevance of Trichoscopy in Differential Diagnosis of Focal Non-cicatricial Alopecia in Children
- ClinicalTrials.gov ID
- NCT03260777
- Acronym / sponsor ID
- ROTIDDOFNCAIC
- Conditions
- Focal Non-cicatricial Alopecia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 Nov 2017 (actual)
- Primary completion
- 1 Sep 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 24 Aug 2017 (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.
Alopecia is a common, distressing condition that is sometimes difficult to diagnose and treat.
Losing hair is not usually health threatening; it can scar a young child's vulnerable self-esteem by causing immense psychological and emotional stress, not only to the patient, but also to the concerned parents and siblings; so the cause of hair loss should be diagnosed and treated early to overcome the resulting problems.
Detailed description
The majority of alopecia in children is presented as patchy alopecia, which is most commonly diagnosed as alopecia areata. However, other causes of patchy alopecia such as tinea capitis, trichotillomania, temporal triangular alopecia (TTA), nevus sebaceous and aplasia cutis congenita (ACC) can be easily missed.
Trichoscopy (hair and scalp dermoscopy) is a non-invasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye.
Trichoscopy allows visualization of hair shafts at high magnification and performing measurements, such as hair shaft thickness, without the need of removing hair for diagnostic purposes. It also allows in vivo visualization of the epidermal portion of hair follicles and perifollicular epidermis.
The advantages of trichoscopy in evaluating hair loss in children are numerous, as it is a fast in-office technique , non-invasive, inexpensive, and painless , and therefore it will be accepted by children and their parents.
Tinea capitis and alopecia areata are considered to be the most common causes of hairless patches of the scalp in pediatrics. Tinea capitis especially non-scaly type may have the same clinical appearance of alopecia areata, so trichoscopy has recently become a useful diagnostic tool for alopecia areata and tinea capitis, especially in doubtful cases as lab investigations like fungal culture or biopsy may take several weeks.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| children with Alopecia Areata | – | Device: Trichoscopy |
| children with tinea capitis | – | Device: Trichoscopy |
| children with trichotillomania | – | Device: Trichoscopy |
| children with tractional alopecia | – | Device: Trichoscopy |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 100 Patients with focal non-cicatricial alopecia will be recruited from the outpatient clinic of Dermatology , Venereology and Andrology department at Assiut University Hospital
Key inclusion criteria (1 listed)
- -age from 3-18 years of both sexes with focal non-cicatricial alopecia.(1-5 patches of alopecia)
Key exclusion criteria (6 listed)
- Patients who will not consent.
- uncooperative children.
- patients with active secondary bacterial infection in the alopecic patch.
- patients with any concomitant dermatological diseases.
- history of using any topical(1 month) or systemic treatment (3 month) for tinea capitis or alopecia areata prior to the study,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrichoscopyTrichoscopy (hair and scalp dermoscopy) is a noninvasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye Structures which may be visualized by trichoscopy include hair shafts of different types, the number of hairs in one pilosebaceous unit, hair follicle openings (dots), the peri and interfollicular areas and the vasculature. | Device | children with Alopecia Areata, children with tinea capitis, children with tractional alopecia, children with trichotillomania |
Primary outcome
Sensitivity and specificity of the common trichoscopic findings in diagnosis of clinically difficult cases of focal non-cicatricial alopecia in children.
Time frame: 2017-2018
Characteristic trichoscopic findings will be searched for in each case such as (exclamation mark hairs, yellow and black dots) for alopecia areata. Flame hairs, tulip hairs, coiled hairs, hook hairs, v-sign and irregularly broken hairs for trichotillomania.Findings for tinea capitis (comma hairs, zigzag hairs, corkscrew hairs and block hairs).Coiled irregularly broken hairs and hair casts for tractional alopecia.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 23937326Lencastre A, Tosti A. Role of trichoscopy in children's scalp and hair disorders. Pediatr Dermatol. 2013 Nov-Dec;30(6):674-82. doi: 10.1111/pde.12173. Epub 2013 Aug 13.
- Background: PubMed 22405573Miteva M, Tosti A. Hair and scalp dermatoscopy. J Am Acad Dermatol. 2012 Nov;67(5):1040-8. doi: 10.1016/j.jaad.2012.02.013. Epub 2012 Mar 8.
- Background: PubMed 23270190Sarifakioglu E, Yilmaz AE, Gorpelioglu C, Orun E. Prevalence of scalp disorders and hair loss in children. Cutis. 2012 Nov;90(5):225-9.
- Background: PubMed 21886722Rakowska A. Trichoscopy (hair and scalp videodermoscopy) in the healthy female. Method standardization and norms for measurable parameters. J Dermatol Case Rep. 2009 Apr 5;3(1):14-9. doi: 10.3315/jdcr.2008.1021.
- Background: PubMed 19341940Hillmann K, Blume-Peytavi U. Diagnosis of hair disorders. Semin Cutan Med Surg. 2009 Mar;28(1):33-8. doi: 10.1016/j.sder.2008.12.005.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Focal Non-cicatricial Alopecia, run by Assiut 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 1 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: finished, as of the sponsor's last update on 13 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of the common trichoscopic findings in diagnosis of clinically difficult cases of focal non-cicatricial alopecia in children. (time frame: 2017-2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03260777, which also lists 5 linked publications.
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 13 Jan 2021.