Fractional Photothermolysis for Hair Follicle Induction

NCT03382184 | Terminated Results FDA Device

• 1 other identifier: 20173385
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Alopecia

Outcome Measures

Primary Outcomes (2)

• 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.

  24 weeks

• 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.

  24 weeks

Secondary Outcomes (1)

• Hair Regrowth Impact on Quality of Life (Improved or Not Improved)

  24 weeks

Study Arms (2)

Fraxel DUAL 1550 nm

EXPERIMENTAL

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

Halo Hybrid Laser 1550 nm

EXPERIMENTAL

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

Interventions

Fraxel Dual laser DEVICE

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.

Fraxel DUAL 1550 nm

Halo laser DEVICE

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

Halo Hybrid Laser 1550 nm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (1)

University of California, Irvine, Department of Dermatology, Dermatology Clinical Research Center, Hewitt Hall

Irvine, California, 92697, United States

Location

Related Publications (6)

• 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.

  PMID: 21199096 BACKGROUND

• 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.

  PMID: 21812832 BACKGROUND

• 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.

  PMID: 25945952 BACKGROUND

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

  PMID: 20725538 BACKGROUND

• 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.

  PMID: 27802065 BACKGROUND

• 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.

  PMID: 27770310 BACKGROUND

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Natasha Mesinkovska, MD, PhD, Associate Professor, Dermatology
• Organization: University of California, Irvine

nmesinko@uci.edu

949-824-5515

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Vice Chair of Dermatology Clinical Research

Model Details: This is a prospective, dual-arm study involving the Fraxel DUAL or Halo laser for the regrowth of hair after alopecia.

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 22, 2017
• Study Start: October 20, 2017
• Primary Completion: May 29, 2019
• Study Completion: May 29, 2019
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)