Fractional Photothermolysis for Hair Loss
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03382184|
Recruitment Status : Recruiting
First Posted : December 22, 2017
Last Update Posted : December 22, 2017
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|
|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)|
|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|
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.
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03382184
|Contact: Margit Juhasz, MDemail@example.com|
|Contact: Chloe Ekelem, MDfirstname.lastname@example.org|
|United States, California|
|University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall||Recruiting|
|Irvine, California, United States, 92697|
|Contact: Margit Juhasz, MD 949-824-1732 email@example.com|
|Contact: Chloe Ekelem, MD 949-824-7103 firstname.lastname@example.org|