AlopeciaThaiScalpBxNCT01651689
Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia
An observational study of Alopecia, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
Hair disorders, expecialy scarring alopecia were diagnosed by scalp biopsy specimens in horizontal and vertical sections.(1-4) Data on hair density in Thais are lacking, although in Asians have more fewer hairs than whites.(5-7)Howevery, previous study from East Asian just had only one study and the data was more… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2010to May 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thai patients who have alopecia and on scadule for hair transplantation
Who may be able to join
- Thai
- Age >= 18 years
- Diagnosis alopecia and on list for hair transplantation in Siriraj hospital
Who cannot join
- Alopecia areata or positive hair pulling test
- Underlying disease : DM, chronic renal failure, chronic liver disease
Trial locations and contacts
1 site in 1 country.
About this study
Hair disorders, expecialy scarring alopecia were diagnosed by scalp biopsy specimens in horizontal and vertical sections.(1-4) Data on hair density in Thais are lacking, although in Asians have more fewer hairs than whites.(5-7)Howevery, previous study from East Asian just had only one study and the data was more differently from West Asian and whites. Then this study was performed to evaluate hair density in Thais, and compared to previous study.
- Conditions
- Alopecia
- Keywords
- Scalp biopsy, Hair count, Vertical section, Horizontal section, Thais
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Scalp biopsy | Subjects are on scadule list for hair transplantation in Siriraj hospital. Scalp biopsy with punch biopsy No.4 Scalp biopsy by punch biopsy No.4 at occipital area was done in subjects who have hair transplantaion. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study startOct 2010
- Primary completionApr 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rattapon Thuangtong, Siriraj Hospital
- Investigators
- Rattapon Thuangtong, MD, Principal investigator, Department of Dermatology, Siriraj hospital, Faculty of Medicine, Mahidol University, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651689
- Sponsor's protocol ID
- SirirajH-003
- Other IDs
- 553/2553(EC3)
- Acronym
- ThaiScalpBx
- Status last verified
- Jul 2012
- First submitted
- 25 Jul 2012
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Elston DM, McCollough ML, Angeloni VL. Vertical and transverse sections of alopecia biopsy specimens: combining the two to maximize diagnostic yield. J Am Acad Dermatol. 1995 Mar;32(3):454-7. doi: 10.1016/0190-9622(95)90068-3.
PubMed 7868715Elston DM, Ferringer T, Dalton S, Fillman E, Tyler W. A comparison of vertical versus transverse sections in the evaluation of alopecia biopsy specimens. J Am Acad Dermatol. 2005 Aug;53(2):267-72. doi: 10.1016/j.jaad.2005.03.007.
PubMed 16021122Garcia C, Poletti E. Scalp biopsy specimens: transverse vs vertical sections. Arch Dermatol. 2007 Feb;143(2):268. doi: 10.1001/archderm.143.2.268-a. No abstract available.
PubMed 17310014Elston DM. Vertical vs. transverse sections: both are valuable in the evaluation of alopecia. Am J Dermatopathol. 2005 Aug;27(4):353-6. doi: 10.1097/01.dad.0000164602.10908.92. No abstract available.
PubMed 16121061Sperling LC. Hair density in African Americans. Arch Dermatol. 1999 Jun;135(6):656-8. doi: 10.1001/archderm.135.6.656.
PubMed 10376692Lee HJ, Ha SJ, Lee JH, Kim JW, Kim HO, Whiting DA. Hair counts from scalp biopsy specimens in Asians. J Am Acad Dermatol. 2002 Feb;46(2):218-21. doi: 10.1067/mjd.2002.119558.
PubMed 11807433Aslani FS, Dastgheib L, Banihashemi BM. Hair counts in scalp biopsy of males and females with androgenetic alopecia compared with normal subjects. J Cutan Pathol. 2009 Jul;36(7):734-9. doi: 10.1111/j.1600-0560.2008.01149.x.
PubMed 19519605
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia
- ClinicalTrials.gov ID
- NCT01651689
- Acronym / sponsor ID
- ThaiScalpBx / SirirajH-003
- Conditions
- Alopecia
- Keywords
- Scalp biopsy, Hair count, Vertical section, Horizontal section, Thais
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 27 Jul 2012 (estimated)
- 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.
Hair disorders, expecialy scarring alopecia were diagnosed by scalp biopsy specimens in horizontal and vertical sections.(1-4) Data on hair density in Thais are lacking, although in Asians have more fewer hairs than whites.(5-7)Howevery, previous study from East Asian just had only one study and the data was more differently from West Asian and whites. Then this study was performed to evaluate hair density in Thais, and compared to previous study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scalp biopsy | – | –Subjects are on scadule list for hair transplantation in Siriraj hospital. Scalp biopsy with punch biopsy No.4 Scalp biopsy by punch biopsy No.4 at occipital area was done in subjects who have hair transplantaion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thai patients who have alopecia and on scadule for hair transplantation
Key inclusion criteria (3 listed)
- Thai
- Age >= 18 years
- Diagnosis alopecia and on list for hair transplantation in Siriraj hospital
Key exclusion criteria (2 listed)
- Alopecia areata or positive hair pulling test
- Underlying disease : DM, chronic renal failure, chronic liver disease
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
- Background: PubMed 7868715Elston DM, McCollough ML, Angeloni VL. Vertical and transverse sections of alopecia biopsy specimens: combining the two to maximize diagnostic yield. J Am Acad Dermatol. 1995 Mar;32(3):454-7. doi: 10.1016/0190-9622(95)90068-3.
- Background: PubMed 16021122Elston DM, Ferringer T, Dalton S, Fillman E, Tyler W. A comparison of vertical versus transverse sections in the evaluation of alopecia biopsy specimens. J Am Acad Dermatol. 2005 Aug;53(2):267-72. doi: 10.1016/j.jaad.2005.03.007.
- Background: PubMed 17310014Garcia C, Poletti E. Scalp biopsy specimens: transverse vs vertical sections. Arch Dermatol. 2007 Feb;143(2):268. doi: 10.1001/archderm.143.2.268-a. No abstract available.
- Background: PubMed 16121061Elston DM. Vertical vs. transverse sections: both are valuable in the evaluation of alopecia. Am J Dermatopathol. 2005 Aug;27(4):353-6. doi: 10.1097/01.dad.0000164602.10908.92. No abstract available.
- Background: PubMed 10376692Sperling LC. Hair density in African Americans. Arch Dermatol. 1999 Jun;135(6):656-8. doi: 10.1001/archderm.135.6.656.
- Background: PubMed 11807433Lee HJ, Ha SJ, Lee JH, Kim JW, Kim HO, Whiting DA. Hair counts from scalp biopsy specimens in Asians. J Am Acad Dermatol. 2002 Feb;46(2):218-21. doi: 10.1067/mjd.2002.119558.
- Background: PubMed 19519605Aslani FS, Dastgheib L, Banihashemi BM. Hair counts in scalp biopsy of males and females with androgenetic alopecia compared with normal subjects. J Cutan Pathol. 2009 Jul;36(7):734-9. doi: 10.1111/j.1600-0560.2008.01149.x.
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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.
Rattapon Thuangtong, MD principal investigator
Department of Dermatology, Siriraj hospital, Faculty of Medicine, Mahidol University, Thailand
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 Alopecia, run by Siriraj Hospital at 1 site in Thailand.
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 3 inclusion and 2 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 27 Jul 2012. 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 Thailand. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01651689, which also lists 7 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 27 Jul 2012.