Hair LossNCT03155958
Ocular Finding in Alopecia Areata
An observational study of Hair Loss, run by Assiut University.
Trial summary
Alopecia areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of hair loss. Several etiological factors, including psychological, trauma-related, genetic and autoimmune factors have been considered as possible etiological factors . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hair Loss
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2017to 1 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.
Who may be able to join
- patients of alopecia areata will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.
Who cannot join
- Patients with documented eye disease.
- Patients with any systemic illness.
- Patients who received any systemic treatment with possible ocular implications in the last three months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ocular Comorbidities of Alopecia Areata
Alopecia areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of hair loss.
Several etiological factors, including psychological, trauma-related, genetic and autoimmune factors have been considered as possible etiological factors . A T cell-mediated autoimmune mechanism in genetically vulnerable individuals is the most acceptable etiology.
Read more
Alopecia areata presents clinically with well demarcated patches of non cicatricial hair loss in any hair bearing area with no remarkable gender preference.
Although AA may occur at any age, incidence is high among younger age groups. In fact, it is the most common form of alopecia seen in children. Various clinical patterns of alopecia have been described as patchy, diffuse, reticulate, ophiasis and ophiasis inversus. Depending on the extent of hair loss, it can be classified into alopecia subtotalis, alopecia totalis (complete loss of scalp hair), and alopecia universalis (complete loss of body hair).
National Alopecia Areata Foundation has devised "Severity of Alopecia Tool Score" (SALT score) as a measure of disease severity. Scalp is divided into 4 areas, namely, Vertex-40% of scalp surface area; right and left profiles-18% each and posterior scalp aspect-24%. SALT score is the sum of percentage of hair loss in the above mentioned areas.
Read the detailed description
Alopecia areata is now considered a systemic autoimmune disease that may have other serious comorbidities, such as cardiovascular and ocular. However, the results of studies of ocular findings in AA are controversial.
Several ocular alterations have been previously reported in patients with AA ranging from minor punctate opacities to cataract. However, there are contrasting opinions on the significance of these lenticular changes. In addition, Horner syndrome, pupil ectopia, iris atrophy, fundus changes , bilateral keratoconus, iris changes and retinal changes have been reported in AA.
Dermoscopy is a noninvasive, diagnostic tool which visualizes subtle patterns of skin lesions not normally visible to the unaided eye. Characteristic dermoscopic finding of AA included black dots , tapering hair corresponding to " exclamation mark hairs " , broken hairs , yellow dots , and clustered short vellus hairs ( shorter than 10 mm).
Since ocular affection can be a profound morbidity factor in patients with AA, we will search deeply in this study about this correlation in order to conclude the value of ocular screening in each and every patient with AA.
- Conditions
- Hair Loss
- Medical subject headings
- Alopecia
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of patient with occular affection in alopecia areata
percentage
Measured: 2 years
Secondary outcomes (1)
correlate dermoscopic finding with disease severity and ocular finding
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hair LossStudies 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155958
- Sponsor's protocol ID
- OCCAA
- Status last verified
- May 2017
- First submitted
- 15 May 2017
- Last updated
- 16 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Madani S, Shapiro J. Alopecia areata update. J Am Acad Dermatol. 2000 Apr;42(4):549-66; quiz 567-70.
PubMed 10727299Esmer O, Karadag R, Cakici O, Bilgili SG, Demircan YT, Bayramlar H, Karadag AS. Ocular findings in patients with alopecia areata. Int J Dermatol. 2016 Jul;55(7):814-8. doi: 10.1111/ijd.13114. Epub 2016 Apr 7.
PubMed 27061214Ergin C, Acar M, Kaya Akis H, Gonul M, Gurdal C. Ocular findings in alopecia areata. Int J Dermatol. 2015 Nov;54(11):1315-8. doi: 10.1111/ijd.12897. Epub 2015 Jul 3.
PubMed 26147700Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. doi: 10.1016/s0190-9622(87)70095-4.
PubMed 3549809Pandhi D, Singal A, Gupta R, Das G. Ocular alterations in patients of alopecia areata. J Dermatol. 2009 May;36(5):262-8. doi: 10.1111/j.1346-8138.2009.00636.x.
PubMed 19382996Recupero SM, Abdolrahimzadeh S, De Dominicis M, Mollo R, Carboni I, Rota L, Calvieri S. Ocular alterations in alopecia areata. Eye (Lond). 1999 Oct;13 ( Pt 5):643-6. doi: 10.1038/eye.1999.174.
PubMed 10696317Nischal KC, Khopkar U. Dermoscope. Indian J Dermatol Venereol Leprol. 2005 Jul-Aug;71(4):300-3. doi: 10.4103/0378-6323.16633. No abstract available.
PubMed 16394450Inui S, Nakajima T, Nakagawa K, Itami S. Clinical significance of dermoscopy in alopecia areata: analysis of 300 cases. Int J Dermatol. 2008 Jul;47(7):688-93. doi: 10.1111/j.1365-4632.2008.03692.x.
PubMed 18613874
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Comorbidities of Alopecia Areata
- ClinicalTrials.gov ID
- NCT03155958
- Acronym / sponsor ID
- OCCAA
- Conditions
- Hair Loss
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 16 May 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 areata (AA) is a common, idiopathic and sometimes recurrent non-scarring type of hair loss.
Several etiological factors, including psychological, trauma-related, genetic and autoimmune factors have been considered as possible etiological factors . A T cell-mediated autoimmune mechanism in genetically vulnerable individuals is the most acceptable etiology.
Alopecia areata presents clinically with well demarcated patches of non cicatricial hair loss in any hair bearing area with no remarkable gender preference.
Although AA may occur at any age, incidence is high among younger age groups. In fact, it is the most common form of alopecia seen in children. Various clinical patterns of alopecia have been described as patchy, diffuse, reticulate, ophiasis and ophiasis inversus. Depending on the extent of hair loss, it can be classified into alopecia subtotalis, alopecia totalis (complete loss of scalp hair), and alopecia universalis (complete loss of body hair).
National Alopecia Areata Foundation has devised "Severity of Alopecia Tool Score" (SALT score) as a measure of disease severity. Scalp is divided into 4 areas, namely, Vertex-40% of scalp surface area; right and left profiles-18% each and posterior scalp aspect-24%. SALT score is the sum of percentage of hair loss in the above mentioned areas.
Detailed description
Alopecia areata is now considered a systemic autoimmune disease that may have other serious comorbidities, such as cardiovascular and ocular. However, the results of studies of ocular findings in AA are controversial.
Several ocular alterations have been previously reported in patients with AA ranging from minor punctate opacities to cataract. However, there are contrasting opinions on the significance of these lenticular changes. In addition, Horner syndrome, pupil ectopia, iris atrophy, fundus changes , bilateral keratoconus, iris changes and retinal changes have been reported in AA.
Dermoscopy is a noninvasive, diagnostic tool which visualizes subtle patterns of skin lesions not normally visible to the unaided eye. Characteristic dermoscopic finding of AA included black dots , tapering hair corresponding to " exclamation mark hairs " , broken hairs , yellow dots , and clustered short vellus hairs ( shorter than 10 mm).
Since ocular affection can be a profound morbidity factor in patients with AA, we will search deeply in this study about this correlation in order to conclude the value of ocular screening in each and every patient with AA.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.
Key inclusion criteria (1 listed)
- patients of alopecia areata will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt.
Key exclusion criteria (3 listed)
- Patients with documented eye disease.
- Patients with any systemic illness.
- Patients who received any systemic treatment with possible ocular implications in the last three months.
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
the number of patient with occular affection in alopecia areata
Time frame: 2 years
percentage
1 secondary outcome
correlate dermoscopic finding with disease severity and ocular finding
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2017.
- Background: PubMed 10727299Madani S, Shapiro J. Alopecia areata update. J Am Acad Dermatol. 2000 Apr;42(4):549-66; quiz 567-70.
- Background: PubMed 27061214Esmer O, Karadag R, Cakici O, Bilgili SG, Demircan YT, Bayramlar H, Karadag AS. Ocular findings in patients with alopecia areata. Int J Dermatol. 2016 Jul;55(7):814-8. doi: 10.1111/ijd.13114. Epub 2016 Apr 7.
- Background: PubMed 26147700Ergin C, Acar M, Kaya Akis H, Gonul M, Gurdal C. Ocular findings in alopecia areata. Int J Dermatol. 2015 Nov;54(11):1315-8. doi: 10.1111/ijd.12897. Epub 2015 Jul 3.
- Background: PubMed 3549809Price VH. Double-blind, placebo-controlled evaluation of topical minoxidil in extensive alopecia areata. J Am Acad Dermatol. 1987 Mar;16(3 Pt 2):730-6. doi: 10.1016/s0190-9622(87)70095-4.
- Background: PubMed 19382996Pandhi D, Singal A, Gupta R, Das G. Ocular alterations in patients of alopecia areata. J Dermatol. 2009 May;36(5):262-8. doi: 10.1111/j.1346-8138.2009.00636.x.
- Background: PubMed 10696317Recupero SM, Abdolrahimzadeh S, De Dominicis M, Mollo R, Carboni I, Rota L, Calvieri S. Ocular alterations in alopecia areata. Eye (Lond). 1999 Oct;13 ( Pt 5):643-6. doi: 10.1038/eye.1999.174.
- Background: PubMed 16394450Nischal KC, Khopkar U. Dermoscope. Indian J Dermatol Venereol Leprol. 2005 Jul-Aug;71(4):300-3. doi: 10.4103/0378-6323.16633. No abstract available.
- Background: PubMed 18613874Inui S, Nakajima T, Nakagawa K, Itami S. Clinical significance of dermoscopy in alopecia areata: analysis of 300 cases. Int J Dermatol. 2008 Jul;47(7):688-93. doi: 10.1111/j.1365-4632.2008.03692.x.
- Individual participant dataSharing planned: No
Related trials for Hair Loss
Enrolling by invitation
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
Androgenic Alopecia, Hair Loss/Baldness
RecruitingPhase 3
A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 3
A Study in Young People and Adults to Learn About the Medicine Ritlecitinib for Treatment of Patchy Hair Loss, Known by the Medical Term as Moderate Alopecia Areata
Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Recruiting
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Alopecia, Chemotherapy-induced Alopecia
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hair Loss, run by Assiut University.
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 3 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: status not confirmed, as of the sponsor's last update on 16 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman Riad, MD (00201005298992, E_raid@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the number of patient with occular affection in alopecia areata (time frame: 2 years). 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 NCT03155958, which also lists 8 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 16 May 2017.