Laser Hair Removal in Healthy SubjectsPhase 1/2NCT00279643
The Effect of Laser Hair Removal on Permanent Hair Reduction
A Phase 1/2 study testing Laser Hair Removal in people with Laser Hair Removal in Healthy Subjects, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to learn more about how hair removal with lasers achieves, what appears to be, permanent hair reduction. Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laser Hair Removal in Healthy Subjects
- What is being tested?
- Laser Hair Removal
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Jun 2006
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or older of either gender.
- At least moderately dense axillary (armpit) hair that is dark (not blonde or white) in color.
- Subjects must understand and sign the informed consent documents prior to participation.
- Subjects must be in generally good health.
- Subjects must be willing and able to comply with the requirements of the protocol
- You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study.
Who cannot join
- Oral retinoid use within one year of study entry.
- History of prior laser therapy or electrolysis of the axillae.
- Subjects who do not desire permanent reduction in axillary hair.
- Non-compliant subjects.
- Pregnant or nursing subjects.
- Subjects with a significant medical history or concurrent illness/condition that the investigator(s) feel is not safe for study participation.
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- Active infection of the site to be treated or a history of herpes simplex or zoster infection at the site to be treated.
- History of keloid scar formation.
- Known history of allergy or sensitivity to lidocaine.
- History of waxing, plucking, or bleaching of the hair for 6 weeks prior to the treatment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109
About this study
Official title: The Effect of Laser Hair Removal on Markers of Follicular Stem Cells
The purpose of this study is to learn more about how hair removal with lasers achieves, what appears to be, permanent hair reduction. Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about how the permanent reduction in the treated areas occurs. Recently, it has been discovered that certain cells in the hair follicle must be destroyed in order to achieve permanent hair reduction. A marker of these types of cells known as keratin 15 has been identified. By measuring the amount of keratin 15 before and after laser therapy, we hope to gain a better understanding of how lasers cause hair reduction on a biochemical level.
Read the detailed description
Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about the mechanisms involved in achieving what clinically appears to be permanent reduction in hair density in treated areas. We postulate that in order to achieve permanent hair reduction, stem cells located in the bulge region of the follicle must be destroyed. Recently, a marker of follicular stem cells (keratin 15) has been identified and noted to be detectable using immunohistochemical techniques. In addition, several other immunohistochemical markers for various components of the hair follicle are available.
We propose to quantitatively measure the effects of laser hair removal on the immunohistochemical staining properties of treated follicles with respect to keratin 15 and other follicular markers. We hypothesize that the degree of such staining will be greatly reduced following laser therapy, thus providing, to our knowledge, the first biochemical evidence to support permanence of the treatment's effects.
- Conditions
- Laser Hair Removal in Healthy Subjects
- Being tested
- Laser Hair Removal
- Keywords
- Laser, immunohistochemical staining, Laser Hair Removal, follicular stem cells, keratin 15
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Hair RemovalProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
measurement of the effects of laser hair removal on the immunohistochemical staining properties of human hair follicles, including the putative stem cells of the bulge region.
Secondary outcomes (1)
Hair Removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2006 (estimated)
- Study startJan 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser Hair Removal in Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey S. Orringer, University of Michigan
- Investigators
- John J Voorhees, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279643
- Sponsor's protocol ID
- Derm 543
- Status last verified
- Apr 2015
- First submitted
- 17 Jan 2006
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Laser Hair Removal on Markers of Follicular Stem Cells
- ClinicalTrials.gov ID
- NCT00279643
- Acronym / sponsor ID
- Derm 543
- Conditions
- Laser Hair Removal in Healthy Subjects
- Keywords
- Laser, immunohistochemical staining, Laser Hair Removal, follicular stem cells, keratin 15
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jan 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Jan 2006 (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.
The purpose of this study is to learn more about how hair removal with lasers achieves, what appears to be, permanent hair reduction. Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about how the permanent reduction in the treated areas occurs. Recently, it has been discovered that certain cells in the hair follicle must be destroyed in order to achieve permanent hair reduction. A marker of these types of cells known as keratin 15 has been identified. By measuring the amount of keratin 15 before and after laser therapy, we hope to gain a better understanding of how lasers cause hair reduction on a biochemical level.
Detailed description
Laser hair removal has become one of the most popular and commonly performed procedures in cosmetic dermatology. However, relatively little is known about the mechanisms involved in achieving what clinically appears to be permanent reduction in hair density in treated areas. We postulate that in order to achieve permanent hair reduction, stem cells located in the bulge region of the follicle must be destroyed. Recently, a marker of follicular stem cells (keratin 15) has been identified and noted to be detectable using immunohistochemical techniques. In addition, several other immunohistochemical markers for various components of the hair follicle are available.
We propose to quantitatively measure the effects of laser hair removal on the immunohistochemical staining properties of treated follicles with respect to keratin 15 and other follicular markers. We hypothesize that the degree of such staining will be greatly reduced following laser therapy, thus providing, to our knowledge, the first biochemical evidence to support permanence of the treatment's effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older of either gender.
- At least moderately dense axillary (armpit) hair that is dark (not blonde or white) in color.
- Subjects must understand and sign the informed consent documents prior to participation.
- Subjects must be in generally good health.
- Subjects must be willing and able to comply with the requirements of the protocol
Key exclusion criteria (10 listed)
- Oral retinoid use within one year of study entry.
- History of prior laser therapy or electrolysis of the axillae.
- Subjects who do not desire permanent reduction in axillary hair.
- Non-compliant subjects.
- Pregnant or nursing subjects.
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 |
|---|---|---|
| Laser Hair Removal | Procedure or surgery | – |
Primary outcome
measurement of the effects of laser hair removal on the immunohistochemical staining properties of human hair follicles, including the putative stem cells of the bulge region.
1 secondary outcome
Hair Removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
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.
John J Voorhees, MD study chair
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Laser Hair Removal in people with Laser Hair Removal in Healthy Subjects, run by University of Michigan at 1 site in United States.
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 6 inclusion and 10 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: finished, as of the sponsor's last update on 30 Apr 2015. 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 United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
measurement of the effects of laser hair removal on the immunohistochemical staining properties of human hair follicles, including the putative stem cells of the bulge region.. 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 30 Apr 2015.