AlopeciaNCT01557491
Hair Regrowth After Bicoronal Incision
A study testing Straight Incision and Bevelled Incision in people with Alopecia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Loss of hair growth potential in long surgical scalp incisions can become obvious to the patient and others, given hair's tendency to part along the resulting scar. Bevelling incisions perpendicular to the hair follicle angle may increase hair growth through the scar. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- Straight Incision and Bevelled Incision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Nov 2013
- Phase
- Interventional
- 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
Who may be able to join
- Bicoronal Incision required as part of surgical plan
- Incision within hair-bearing scalp
Who cannot join
- Previous Bicoronal Incision
- Unfit for Surgery
- Unable to provide informed consent
- Unable to comply with followup
- Preexisting alopecia of scalp
- Cutaneous malignancy of scalp
Trial locations and contacts
1 site in 1 country.
Mathew A Plant, MD contact
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N3M5
Jeffrey Fialkov, MD, 4164804257
Jeffrey Fialkov, MD, FRCSC
About this study
Official title: A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions.
Loss of hair growth potential in long surgical scalp incisions can become obvious to the patient and others, given hair's tendency to part along the resulting scar. Bevelling incisions perpendicular to the hair follicle angle may increase hair growth through the scar. However, many factors may be confounders such as wound tension and cauterizing the incision. This study will investigate the effect a bevelled incision has on hair growth preservation compared to a standard incision that incises the skin perpendicular to its surface irrespective of hair follicle angles. Following informed voluntary consent, subjects who require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The right side of this bilateral incision will be randomized to receive either a bevelled or a standard incision and the left side will receive the opposite type. During routine surgical follow-up the hair growth within the scar of the two sides will be recorded for comparison and it is our hypothesis that the side with the bevelled incision will have more hair within the scar.
- Conditions
- Alopecia
- Being tested
- Straight Incision, Bevelled Incision
- Keywords
- Alopecia, Coronal Incision, Scar Quality
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Straight IncisionProcedure or surgery
The incision will be made at a 90 degree angle to the surface of the scalp
Bevelled IncisionProcedure or surgery
The Incision will be made at a 45 degree angle to the surface of the scalp.
| Study group | Role | What they receive |
|---|---|---|
| Straight Incision | Active comparator | incision made perpendicular to scalp surface Receives: Procedure: Straight Incision |
| Bevelled Incision | Active comparator | Incision made at 45 degrees to scalp surface Receives: Procedure: Bevelled Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hair Regrowth Within the Scar
Hair growth through the scar will be counted at 6 and 12 month followup
Measured: 12 months
Secondary outcomes (1)
Scar Characteristics
Scars will be rated based on the Vancouver Scar Scale (Sullivan, 1990)
Measured: 1 year post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionNov 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jeff Fialkov, Sunnybrook Health Sciences Centre
- Investigators
- Mathew A Plant, MD, Study director, University of Toronto Plastic and Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557491
- Sponsor's protocol ID
- 8080808
- Status last verified
- Mar 2012
- First submitted
- 15 Mar 2012
- Last updated
- 19 Mar 2012
- Results posted
- No
Publications
Camirand A, Doucet J. A comparison between parallel hairline incisions and perpendicular incisions when performing a face lift. Plast Reconstr Surg. 1997 Jan;99(1):10-5. doi: 10.1097/00006534-199701000-00002.
PubMed 8982181Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
PubMed 2373734
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Blinded Comparison of Hair Growth Following Either Bevelled or Standard Bi-coronal Scalp Incisions.
- ClinicalTrials.gov ID
- NCT01557491
- Acronym / sponsor ID
- 8080808
- Conditions
- Alopecia
- Keywords
- Alopecia, Coronal Incision, Scar Quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Nov 2013 (estimated)
- First posted
- 19 Mar 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.
Loss of hair growth potential in long surgical scalp incisions can become obvious to the patient and others, given hair's tendency to part along the resulting scar. Bevelling incisions perpendicular to the hair follicle angle may increase hair growth through the scar. However, many factors may be confounders such as wound tension and cauterizing the incision. This study will investigate the effect a bevelled incision has on hair growth preservation compared to a standard incision that incises the skin perpendicular to its surface irrespective of hair follicle angles. Following informed voluntary consent, subjects who require bi-coronal scalp incisions as part of a surgical plan will be enrolled. The right side of this bilateral incision will be randomized to receive either a bevelled or a standard incision and the left side will receive the opposite type. During routine surgical follow-up the hair growth within the scar of the two sides will be recorded for comparison and it is our hypothesis that the side with the bevelled incision will have more hair within the scar.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Straight Incision | Active comparator | Procedure: Straight Incisionincision made perpendicular to scalp surface |
| Bevelled Incision | Active comparator | Procedure: Bevelled IncisionIncision made at 45 degrees to scalp surface |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bicoronal Incision required as part of surgical plan
- Incision within hair-bearing scalp
Key exclusion criteria (6 listed)
- Previous Bicoronal Incision
- Unfit for Surgery
- Unable to provide informed consent
- Unable to comply with followup
- Preexisting alopecia of scalp
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 |
|---|---|---|
| Straight IncisionThe incision will be made at a 90 degree angle to the surface of the scalp | Procedure or surgery | Straight Incision |
| Bevelled IncisionThe Incision will be made at a 45 degree angle to the surface of the scalp. | Procedure or surgery | Bevelled Incision |
Primary outcome
Hair Regrowth Within the Scar
Time frame: 12 months
Hair growth through the scar will be counted at 6 and 12 month followup
1 secondary outcome
Scar Characteristics
Time frame: 1 year post surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Background: PubMed 8982181Camirand A, Doucet J. A comparison between parallel hairline incisions and perpendicular incisions when performing a face lift. Plast Reconstr Surg. 1997 Jan;99(1):10-5. doi: 10.1097/00006534-199701000-00002.
- Background: PubMed 2373734Sullivan T, Smith J, Kermode J, McIver E, Courtemanche DJ. Rating the burn scar. J Burn Care Rehabil. 1990 May-Jun;11(3):256-60. doi: 10.1097/00004630-199005000-00014.
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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.
Mathew A Plant, MD contact
Mathew A Plant, MD study director
University of Toronto Plastic and Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Straight Incision and Bevelled Incision in people with Alopecia, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 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 Canada. 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?
Contact Mathew A Plant, MD (mplant2008@meds.uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair Regrowth Within the Scar (time frame: 12 months). 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 NCT01557491, which also lists 2 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 19 Mar 2012.