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Fractional Photothermolysis for Hair Follicle Induction

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ClinicalTrials.gov Identifier: NCT03382184
Recruitment Status : Active, not recruiting
First Posted : December 22, 2017
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Beckman Laser Institute
Information provided by (Responsible Party):
Margit Juhasz, MD, University of California, Irvine

Brief 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). 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.


Condition or disease Intervention/treatment Phase
Alopecia Device: Fraxel Dual laser Device: Halo laser Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Fractional Photothermolysis for the Treatment of Hair Loss
Actual Study Start Date : October 20, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fraxel DUAL 1550 nm
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. 25 patients with alopecia will be part of this group.
Device: Fraxel Dual laser
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.

Experimental: Halo Hybrid Laser 1550 nm
The 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.
Device: Halo laser
The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.




Primary Outcome Measures :
  1. Hair regrowth by dermoscopy [ Time Frame: 24 weeks ]
    Hair will be counted before and after treatment using dermoscopy on both the treated and untreated scalp.

  2. Hair regrowth by optical coherence tomography (OCT). [ Time Frame: 24 weeks ]
    Hair will be counted before and after treatment using OCT on both the treated and untreated scalp.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 24 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382184


Locations
United States, California
University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall
Irvine, California, United States, 92697
Sponsors and Collaborators
University of California, Irvine
Beckman Laser Institute

Publications:
Responsible Party: Margit Juhasz, MD, Clincail Research Fellow, University of California, Irvine
ClinicalTrials.gov Identifier: NCT03382184     History of Changes
Other Study ID Numbers: 2017-3385
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Currently there is no plan to share individual participant data with other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical