NCT01655602

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 2, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

8 months

First QC Date

July 17, 2012

Last Update Submit

August 1, 2012

Conditions

Androgenetic Alopecia

Keywords

Trichophytic closurehair transplantationdonor siteAndrogenetic alopecia

Outcome Measures

Primary Outcomes (1)

  • 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\*

    1 week, 4 week, 12 week, 24 week

Secondary Outcomes (1)

  • Number of Participants with wound complication

    immediate, 1week, 4week, 12week, 24week

Study Arms (3)

upper edge trimming

EXPERIMENTAL

Surgery: trichophytic closure The 1-millimetre trimming of upper edge of linear incision before wound closure

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

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

Procedure: Trichophytic closure both edge trimming

Interventions

Trichophytic closure upper edge trimmingPROCEDURE

'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.

Also known as: upper Trichophytic, upper edge trimming
upper edge trimming
Trichophytic closure lower edge trimmingPROCEDURE

'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.

Also known as: lower trichophytic closure, lower edge trimming
lower edge trimming
Trichophytic closure both edge trimmingPROCEDURE

'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.

Also known as: both edge Trichophytic closure, both edge trimming
Both edge trimming

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male
  • Age of 25 or more
  • Diagnosis of androgenetic alopecia
  • Do not response to conventional treatment and undergo hair transplantation surgery

You may not qualify if:

  • Have skin lesion at donor site
  • Psychological disturbance including trichotillomania
  • Anti-HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok, Bangkok, 10700, Thailand

RECRUITING

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Rattapon Thuangtong, MD

    Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rattapon Thuangtong, MD

CONTACT

+662-419-4333rattaponthuangtong@yahoo.com

Saroj Suvanasuthi, MD, PhD

CONTACT

+662-419-4333doctorhe@gmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 17, 2012

First Posted

August 2, 2012

Study Start

July 1, 2012

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

TH(1)