AlopeciaNCT03284021
Fraxel Laser for Alopecia
A study testing Fractional erbium-glass 1550 nm laser in people with Alopecia, run by Northwestern University at 1 site in United States.
Trial summary
This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alopecia
- What is being tested?
- Fractional erbium-glass 1550 nm laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2019to 24 Apr 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years old
- Subjects are in good health as judged by the investigator.
- Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata.
- Subject is seeking treatment for alopecia.
- Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
- Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator.
Who cannot join
- Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
- Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
- Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
- History of recurrent facial or labial herpes simplex infection
- History of hypertrophic scars or keloids
- Subjects who have any requirement for the use of local or systemic steroids or other immunosuppressive agent
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- Pregnant or breast feeding
- Uncooperative patients or patients with neurological disorders who are incapable of following directions or who are predictably unwilling to return for follow-up examinations.
- Subjects who are unable to understand the protocol or give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Department of Dermatology
Chicago, Illinois, 60611
About this study
Official title: A Pilot Study on 1550 nm Fractional Erbium-glass Laser for Alopecia Treatment
This is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the scalp. Follow-up is at 150 days.
This study was a pilot study designed to determine feasibility of this procedure.
- Conditions
- Alopecia
- Being tested
- Fractional erbium-glass 1550 nm laser
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fractional erbium-glass 1550 nm laserDevice
Also called Fraxel RE:STORE
The fractional erbium-glass 1550 nm laser will be applied to the previously 100 cm2 determined area of the scalp with the following parameters: 5-10 mm tip, 5-10 mJ, pulse energy 500-1500 MTZ/cm2 density, one to twopasses, static mode.
| Study group | Role | What they receive |
|---|---|---|
| Fraxel laser | Other | Not described Receives: Device: Fractional erbium-glass 1550 nm laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical change of alopecia from baseline to 150 days.
Outcome assessors will measure clinical change using the Jaeschke scale, a 15 point scale that describes how worse or better the condition is.
Measured: Baseline and 150 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study start24 Apr 2019 (estimated)
- Primary completion24 Apr 2019 (estimated)
- Study completion24 Apr 2019 (estimated)
Why it stopped: The study did not start.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murad Alam, Northwestern University
- Investigators
- Murad Alam, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284021
- Sponsor's protocol ID
- STU00205107
- Status last verified
- Dec 2021
- First submitted
- 13 Sep 2017
- Last updated
- 6 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on 1550 nm Fractional Erbium-glass Laser for Alopecia Treatment
- ClinicalTrials.gov ID
- NCT03284021
- Acronym / sponsor ID
- STU00205107
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study did not start.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Apr 2019 (estimated)
- Primary completion
- 24 Apr 2019 (estimated)
- Study completion
- 24 Apr 2019 (estimated)
- First posted
- 15 Sep 2017 (actual)
- 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 is a pilot study to evaluate the effect of the 1550 nm fractional erbium-glass laser in patients with nonscarring alopecias. Participants currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment. Participants will receive 5 sessions of laser, 30 days apart, to the area of alopecia on the scalp. Follow-up is at 150 days.
This study was a pilot study designed to determine feasibility of this procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fraxel laser | Other | Device: Fractional erbium-glass 1550 nm laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females ≥ 18 years old
- Subjects are in good health as judged by the investigator.
- Diagnosed by a dermatologist with mild to moderate androgenetic alopecia or alopecia areata.
- Subject is seeking treatment for alopecia.
- Subject has never previously used finasteride or minoxidil or has consistently used finasteride or minoxidil for at least 1 year.
Key exclusion criteria (9 listed)
- Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments.
- Subjects who are unwilling to avoid initiating treatment with minoxidil or finasteride for the duration of the study; or in subjects who have been treated with minoxidil or finasteride for at least 1 year, unwilling to avoid changes in the dosing regimen of these medications for the duration of the study.
- Willing to refrain from washing hair or using hair product 24 hours before and after treatment visits
- History of recurrent facial or labial herpes simplex infection
- History of hypertrophic scars or keloids
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 |
|---|---|---|
| Fractional erbium-glass 1550 nm laserAlso: Fraxel RE:STOREThe fractional erbium-glass 1550 nm laser will be applied to the previously 100 cm2 determined area of the scalp with the following parameters: 5-10 mm tip, 5-10 mJ, pulse energy 500-1500 MTZ/cm2 density, one to twopasses, static mode. | Device | Fraxel laser |
Primary outcome
Clinical change of alopecia from baseline to 150 days.
Time frame: Baseline and 150 Days
Outcome assessors will measure clinical change using the Jaeschke scale, a 15 point scale that describes how worse or better the condition is.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Murad Alam, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional erbium-glass 1550 nm laser in people with Alopecia, run by Northwestern University 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 9 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: withdrawn, as of the sponsor's last update on 6 Dec 2021. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical change of alopecia from baseline to 150 days. (time frame: Baseline and 150 Days). 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 6 Dec 2021.