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AlopeciaNCT03382184

Fractional Photothermolysis for Hair Follicle Induction

A study testing Fraxel Dual laser and Halo laser in people with Alopecia, run by University of California, Irvine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is being done to evaluate the effects of fractional photothermolysis (known as laser resurfacing) using fractional laser for the induction of hair follicles via skin rejuvenation in subjects with scalp alopecia (specifically, alopecia on the superior forehead at the frontal hairline). Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Alopecia
What is being tested?
Fraxel Dual laser and Halo laser
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited States
Study dates
20 Oct 2017to 29 May 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must be between the ages of 18 to 90 years old
  • Diagnosed with hair loss on scalp by a dermatology
  • No other treatments for hair loss have been done in the past 1 month
  • No evidence of spontaneous hair growth
  • Good health
  • Must agree to comply with study treatment and protocol
  • Healthy scalp without evidence of neoplasm
  • Scarring and/or non-scarring alopecia acceptable

Who cannot join

  • Any visible signs of neoplasm, infection, inflammatory disease of the scalp
  • No history of photosensitivity, impaired wound healing, chronic liver or kidney disease
  • No concurrent use of minoxidil/Rogaine, platelet-rich plasma (PRP), or light devices for hair regrowth
  • Has not initiated use of finasteride/Propecia or spironolactone in the 3 months preceding the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall

    Irvine, California, 92697

Other trials in United States

About this study

Official title: Fractional Photothermolysis for the Induction of Hair Follicles Via Skin Rejuvenation

This study is being done to evaluate the effects of fractional photothermolysis (known as laser resurfacing) using fractional laser for the induction of hair follicles via skin rejuvenation in subjects with scalp alopecia (specifically, alopecia on the superior forehead at the frontal hairline). Fractional photothermolysis has been shown to be effective in promoting hair growth. The investigators will study 50 subjects who will be treated 6-10 times at 2-4 week intervals. Each participant will have half of their head treated with a laser, either Fraxel DUAL 1550 or Halo by Sciton, and the other half of their head will be left untreated as a control. Half of the individuals will randomly be assigned to the group to be treated with Fraxel DUAL 1550, and the other half will be treated with Halo by Sciton. Visual observation and digital, photographic, non-invasive imaging will be used to compare the treated and untreated area to assess for differences in hair follicle stimulation rates, number and density of hairs.

As noted above, the types of lasers we plan to use include the non-ablative fractional laser settings for the Fraxel DUAL 1550 and Halo by Sciton. A fractional laser is a laser that directs an intense burst of laser energy on the skin. The treatment deposits heat deep into the dermis to tighten skin and stimulate collagen remodeling. The necrotic (death of cells or tissue) injury heals rapidly and adverse effects are few. Laser resurfacing is commonly used for rejuvenation of the skin to improve quality, tone, and texture.

Read the detailed description

Introduction Alopecia is also known as hair loss, and it occurs due to aging, nutritional or hormonal imbalance, or immune system etiology. It affects both males and females of different ages and races. Hair may fall out in clumps, break off leaving short stubs, or become thinner over time. The alopecia can be of a scarring or non-scarring nature. The most common form of hair loss is non-scarring, or noncicatricial, alopecia. In this case, the damage is not permanent, and although hair loss cannot be cured, it can be treated. Hair loss is usually not a sign of an underlying medical disorder. However, hair loss may affect self-esteem and cause anxiety affecting the quality of life. Scarring, or cicatricial, alopecia is a rare disorder that destroys the hair follicle and replaces it with scar tissue, resulting in permanent hair loss.

Causes

There are many genes that contribute to hair loss, so it can be hereditary. There are also other causes, including:

  • Thyroid disorders
  • Pregnancy
  • Anemia
  • Autoimmune diseases like polycystic ovarian syndrome
  • Skin conditions like Psoriasis and seborrheic dermatitis

Treatment Options Topical Minoxidil (Rogaine) and anti-inflammatory medications, such as topical and intra-lesional steroids, are used for alopecia. It is a solution that is applied directly to the scalp to stimulate the hair follicle. It slows hair loss, and some people grow new hair. Hair loss returns when the medication is stopped.

Finasteride is a prescription medicine that interferes with the production of a highly active form of testosterone that is linked to baldness. It slows hair loss. It works slightly better than minoxidil. Hair loss returns when you stop using the medicine. This prescription medication is also sometimes given to women who have been through menopause. Its role in female pattern hair loss is controversial, with both success and failure reported to occur.

Dutasteride is similar to finasteride, but may be more effective.

Hair transplants are also an option, though they are invasive and expensive. It consists of removing tiny plugs of hair from areas where the hair is continuing to grow and placing them in areas that are balding. This can cause minor scarring and possibly infection.

New Therapy Fractional photothermolysis was originally designed as a form of laser therapy to treat wrinkles and scars. Although the link between laser treatment and hair growth is not clear and the exact mechanism still unknown, there is evidence to support that laser irradiation holds potential for the induction of hair follicles in subjects with alopecia. Laser therapy has been reported to increase hair growth and activate hair follicles. The lasers rejuvenate skin, and hair follicles are a part of skin, along with nails, so through the rejuvenation of skin, these things also get rejuvenated. Clinical examples of photo-induced hair growth include the paradoxical hair growth after laser hair removal, and hair growth after some level of wound healing by lasers has been performed. Several studies have been performed, analyzing the effectiveness of laser treatment of different settings, and researchers have observed an increase in hair numbers and density on the treatment side of the head. Improvements were most notable when the laser settings followed a low energy and high density protocol. A review of the literature demonstrates that more research needs to be done on this topic, but fractional photothermolysis may be a new, effective way to treat different types of hair loss. The types of lasers the investigators plan to use include Fraxel restore and Sciton Halo, a fractional hybrid laser that combines fractional erbium ablative lasers with a fractional non-ablative laser. The use of the fractional photothermolysis Fraxel laser and Sciton Halo laser have been approved by the FDA for treatment of the hands, face, and body. Fraxel received aesthetic clearance in November 2003.

These lasers do not meet the definition of a significant risk device because the investigators do not believe that they present a potential for serious risk to the health, safety, or welfare of a subject. Side effects that have been reported from use with these lasers include redness and tenderness in the area that it was applied, and these side effects don't last more than a couple days. These lasers do not impair human health.

Conditions
Alopecia
Being tested
Fraxel Dual laser, Halo laser
Medical subject headings
Alopecia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fraxel Dual laserDevice

    The Fraxel DUAL 1550 nm laser will be used at 7 mJ, 8 pulses, 120 spots/cm2, treatment level 3 (9% coverage) for hair regrowth.

  • Halo laserDevice

    The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.

Study groups in NCT03382184
Study groupRoleWhat they receive
Fraxel DUAL 1550 nmExperimentalThe Fraxel DUAL 1550 nm laser will be used at 7 mJ, 8 pulses, 120 spots/cm2, treatment level 3 (9% coverage) for hair regrowth. 25 patients with alopecia will be part of this group.
Receives: Device: Fraxel Dual laser
Halo Hybrid Laser 1550 nmExperimentalThe Halo laser will be used per protocol due to the dynamic thermal optimization technology for hair regrowth. 25 patients with alopecia will be part of this group.
Receives: Device: Halo laser

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hair Density Change by as Seen by Dermoscopy

    Hair density will be measured as increased or decreased before and after treatment using dermoscopy on both the treated and untreated scalp.

    Measured: 24 weeks

  2. Hair Density Change as Seen by Optical Coherence Tomography (OCT).

    Hair density will be measured as increased or decreased before and after treatment using OCT on both the treated and untreated scalp.

    Measured: 24 weeks

Secondary outcomes (1)
  1. Hair Regrowth Impact on Quality of Life (Improved or Not Improved)

    Patients will be asked how hair regrowth has affected their quality of life over the period of 12 weeks of treatment and then 12 weeks of follow-up using a Likert scale (1-5, worse to very much improved).

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2017
  2. Study start20 Oct 2017
  3. Primary completion29 May 2019
  4. Study completion29 May 2019

Why it stopped: The study procedures and enrollment were stopped due to COVID-19 restrictions on non-essential research. The study was not able to continue due to change in research personnel after research was able to resume.

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
This is a prospective, dual-arm study involving the Fraxel DUAL or Halo laser for the regrowth of hair after alopecia.
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03382184
Sponsor's protocol ID
20173385
Status last verified
Mar 2026
First submitted
13 Dec 2017
Last updated
3 Mar 2026
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Currently there is no plan to share individual participant data with other researchers.

Publications

  • Kim WS, Lee HI, Lee JW, Lim YY, Lee SJ, Kim BJ, Kim MN, Song KY, Park WS. Fractional photothermolysis laser treatment of male pattern hair loss. Dermatol Surg. 2011 Jan;37(1):41-51. doi: 10.1111/j.1524-4725.2010.01833.x. Epub 2010 Dec 28.

    PubMed 21199096
  • Lee GY, Lee SJ, Kim WS. The effect of a 1550 nm fractional erbium-glass laser in female pattern hair loss. J Eur Acad Dermatol Venereol. 2011 Dec;25(12):1450-4. doi: 10.1111/j.1468-3083.2011.04183.x. Epub 2011 Aug 4.

    PubMed 21812832
  • Bae JM, Jung HM, Goo B, Park YM. Hair regrowth through wound healing process after ablative fractional laser treatment in a murine model. Lasers Surg Med. 2015 Jul;47(5):433-40. doi: 10.1002/lsm.22358. Epub 2015 May 6.

    PubMed 25945952
  • Update on fractional laser technology. J Clin Aesthet Dermatol. 2010 Jan;3(1):42-50. No abstract available.

    PubMed 20725538
  • Mlacker S, Aldahan AS, Simmons BJ, Shah V, McNamara CA, Samarkandy S, Nouri K. A review on laser and light-based therapies for alopecia areata. J Cosmet Laser Ther. 2017 Apr;19(2):93-99. doi: 10.1080/14764172.2016.1248440. Epub 2017 Jan 25.

    PubMed 27802065
  • Gupta AK, Carviel J, Abramovits W. Treating Alopecia Areata: Current Practices Versus New Directions. Am J Clin Dermatol. 2017 Feb;18(1):67-75. doi: 10.1007/s40257-016-0230-4.

    PubMed 27770310

Questions about this trial

What is this clinical trial studying?

A study testing Fraxel Dual laser and Halo laser in people with Alopecia, run by University of California, Irvine 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 3 Mar 2026. 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?

Yes. Results are posted in the registry (first posted 3 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Hair Density Change by as Seen by Dermoscopy (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 NCT03382184, which also lists 6 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 3 Mar 2026.

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