Androgenetic AlopeciaPhase 1NCT01655602
Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation
A Phase 1 study testing Trichophytic closure upper edge trimming, Trichophytic closure lower edge trimming and Trichophytic closure both edge trimming in people with Androgenetic Alopecia, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
This study aim to compare cosmetic results between 3 trichophytic closure techniques for donor site (the trimming of upper, lower and both edge of linear incision) in hair transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Trichophytic closure upper edge trimming, Trichophytic closure lower edge trimming and Trichophytic closure both edge trimming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2012to May 2013
- Phase
- Phase 1
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male
- Age of 25 or more
- Diagnosis of androgenetic alopecia
- Do not response to conventional treatment and undergo hair transplantation surgery
Who cannot join
- Have skin lesion at donor site
- Psychological disturbance including trichotillomania
- Anti-HIV positive
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok, Bangkok, 10700
Rattapon Thuangtong, MD, +662-419-4333, rattaponthuangtong@yahoo.com
Kanchalit Thanomkitti, MD, +662-419-4333, kanchalitt@hotmail.com
About this study
This study aim to compare cosmetic results between 3 trichophytic closure techniques for donor site (the trimming of upper, lower and both edge of linear incision) in hair transplantation.
Read the detailed description
Strip harvesting technique, a conventional hair transplantation procedure, is widely used in the treatment of androgenetic alopecia for more than half a century. It provides less time-consuming, more feasible and more cost-effective comparing with follicular unit extraction (FUE) technique. However, linear scar at the donor site is also introduced.
The latest method to fine the scar at the donor site was invented and known as 'Trichophytic closure technique'. It can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
This research is a pilot, split-wound comparison study of trichophytic closure techniques for donor site in hair transplantation.10 males, aged ≥ 25 years, who require strip harvesting follicular unit transplantation in the treatment of androgenetic alopecia will be enrolled. Preoperative and perioperative process will be conducted as standard procedure except wound closure technique. Each incision wound of donor site will be equally divided into 3 parts (marked with tattoos as Fig.2) and each part will be randomly treated with different trichophytic closure techniques as below.
- The 1-millimetre trimming of upper edge of linear incision before wound closure
- The 1-millimetre trimming of lower edge of linear incision before wound closure
- The 0.5-millimetre trimming of both edge of linear incision before wound closure For evaluation, we have planned to assess both cosmetic results and side effects as shown in the table. ( Table 1 - image file ) After data collecting process, we have planned to analyze the demographic data, rate of infection and other side effects in a descriptive manner. However, the evaluation for cosmetic results will be analyzed by paired t-test in the same technique at different follow up period and by one-way ANOVA between each technique at the same follow up period.
- Conditions
- Androgenetic Alopecia
- Being tested
- Trichophytic closure upper edge trimming, Trichophytic closure lower edge trimming, Trichophytic closure both edge trimming
- Keywords
- Trichophytic closure, hair transplantation, donor site, Androgenetic alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trichophytic closure upper edge trimmingProcedure or surgery
Also called upper Trichophytic, upper edge trimming
'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
Trichophytic closure lower edge trimmingProcedure or surgery
Also called lower trichophytic closure, lower edge trimming
'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
Trichophytic closure both edge trimmingProcedure or surgery
Also called both edge Trichophytic closure, both edge trimming
'Trichophytic closure technique' can be done by trimming upper and lower wound edge for about 0.5 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
| Study group | Role | What they receive |
|---|---|---|
| upper edge trimming | Experimental | Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure Receives: Procedure: Trichophytic closure upper edge trimming |
| lower edge trimming | Experimental | Surgery: trichophytic closure The 1-millimetre trimming of lower edge of linear incision before wound closure Receives: Procedure: Trichophytic closure lower edge trimming |
| Both edge trimming | Experimental | Surgery: trichophytic closure The 0.5-millimetre trimming of both edge of linear incision before wound closure Receives: Procedure: Trichophytic closure both edge trimming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changing of scar on the donor site during time courses
- Hair density
- Width of scar
- Global photographic view (taken with Cannon 60D 18.0 Megapixels 100 mm macro lens)
- Uninvolved dermatologist's assessment *
- Self assessment*
Measured: 1 week, 4 week, 12 week, 24 week
Secondary outcomes (1)
Number of Participants with wound complication
Record number of patient who have wound problem example Hematoma, Wound separation, wound Infection, etc.
Measured: immediate, 1week, 4week, 12week, 24week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMar 2013 (estimated)
- Study completionMay 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 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, Faculty of Medicine Siriraj Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655602
- Sponsor's protocol ID
- SirirajH-005
- Other IDs
- 825/2554EC3
- Status last verified
- Jul 2012
- First submitted
- 17 Jul 2012
- Last updated
- 2 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Split Wound Comparison of Trichophytic Closure Techniques for Donor Site in Hair Transplantation
- ClinicalTrials.gov ID
- NCT01655602
- Acronym / sponsor ID
- SirirajH-005
- Conditions
- Androgenetic Alopecia
- Keywords
- Trichophytic closure, hair transplantation, donor site, Androgenetic alopecia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Mar 2013 (estimated)
- Study completion
- May 2013 (estimated)
- First posted
- 2 Aug 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.
This study aim to compare cosmetic results between 3 trichophytic closure techniques for donor site (the trimming of upper, lower and both edge of linear incision) in hair transplantation.
Detailed description
Strip harvesting technique, a conventional hair transplantation procedure, is widely used in the treatment of androgenetic alopecia for more than half a century. It provides less time-consuming, more feasible and more cost-effective comparing with follicular unit extraction (FUE) technique. However, linear scar at the donor site is also introduced.
The latest method to fine the scar at the donor site was invented and known as 'Trichophytic closure technique'. It can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
This research is a pilot, split-wound comparison study of trichophytic closure techniques for donor site in hair transplantation.10 males, aged ≥ 25 years, who require strip harvesting follicular unit transplantation in the treatment of androgenetic alopecia will be enrolled. Preoperative and perioperative process will be conducted as standard procedure except wound closure technique. Each incision wound of donor site will be equally divided into 3 parts (marked with tattoos as Fig.2) and each part will be randomly treated with different trichophytic closure techniques as below.
- The 1-millimetre trimming of upper edge of linear incision before wound closure
- The 1-millimetre trimming of lower edge of linear incision before wound closure
- The 0.5-millimetre trimming of both edge of linear incision before wound closure For evaluation, we have planned to assess both cosmetic results and side effects as shown in the table. ( Table 1 - image file ) After data collecting process, we have planned to analyze the demographic data, rate of infection and other side effects in a descriptive manner. However, the evaluation for cosmetic results will be analyzed by paired t-test in the same technique at different follow up period and by one-way ANOVA between each technique at the same follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| upper edge trimming | Experimental | Procedure: Trichophytic closure upper edge trimmingSurgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure |
| lower edge trimming | Experimental | Procedure: Trichophytic closure lower edge trimmingSurgery: trichophytic closure The 1-millimetre trimming of lower edge of linear incision before wound closure |
| Both edge trimming | Experimental | Procedure: Trichophytic closure both edge trimmingSurgery: trichophytic closure The 0.5-millimetre trimming of both edge of linear incision before wound closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- Age of 25 or more
- Diagnosis of androgenetic alopecia
- Do not response to conventional treatment and undergo hair transplantation surgery
Key exclusion criteria (3 listed)
- Have skin lesion at donor site
- Psychological disturbance including trichotillomania
- Anti-HIV positive
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 |
|---|---|---|
| Trichophytic closure upper edge trimmingAlso: upper Trichophytic, upper edge trimming'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique. | Procedure or surgery | upper edge trimming |
| Trichophytic closure lower edge trimmingAlso: lower trichophytic closure, lower edge trimming'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique. | Procedure or surgery | lower edge trimming |
| Trichophytic closure both edge trimmingAlso: both edge Trichophytic closure, both edge trimming'Trichophytic closure technique' can be done by trimming upper and lower wound edge for about 0.5 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique. | Procedure or surgery | Both edge trimming |
Primary outcome
Changing of scar on the donor site during time courses
Time frame: 1 week, 4 week, 12 week, 24 week
* Hair density * Width of scar * Global photographic view (taken with Cannon 60D 18.0 Megapixels 100 mm macro lens) * Uninvolved dermatologist's assessment * * Self assessment*
1 secondary outcome
Number of Participants with wound complication
Time frame: immediate, 1week, 4week, 12week, 24week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2012.
Related trials for Androgenetic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
RecruitingPhase 1/2
Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia
Androgenetic Alopecia (AGA), Healthy Volunteers - Male and Female
RecruitingPhase 2/3
Phase 2/3 Efficacy and Safety of PP405 in Adult Males
Androgenetic Alopecia
Enrolling by invitation
Study to Evaluate Xtressé Gummy Supplement in Men With Androgenic Alopecia
Androgenic Alopecia, Hair Loss/Baldness
Recruiting
A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia
Androgenetic 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.
Rattapon Thuangtong, MD principal investigator
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trichophytic closure upper edge trimming, Trichophytic closure lower edge trimming and Trichophytic closure both edge trimming in people with Androgenetic 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 4 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 2 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Rattapon Thuangtong, MD (+662-419-4333, rattaponthuangtong@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changing of scar on the donor site during time courses (time frame: 1 week, 4 week, 12 week, 24 week). 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 2 Aug 2012.