Fractional Photothermolysis for Alopecia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: University of California, Irvine

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people aged 18 to 90 with alopecia on the scalp, specifically at the frontal hairline. Participants should be in good health, have not received other hair loss treatments in the past month, and must commit to following the study protocol. Those with a healthy scalp without tumors are eligible; both scarring and non-scarring alopecia are acceptable.

Inclusion Criteria

I have not experienced any unexpected hair regrowth.

I am between 18 and 90 years old.

I have been diagnosed with scalp hair loss by a dermatologist.

My scalp is healthy and cancer-free.

Participant Groups

The study tests fractional photothermolysis (laser resurfacing) using two types of lasers: Fraxel DUAL 1550 or Halo by Sciton. It aims to stimulate hair growth through skin rejuvenation. Fifty subjects will receive treatment up to ten times over several weeks, with one side of their head treated and the other as control.

2Treatment groups

Experimental Treatment

Group I: Halo Hybrid Laser 1550 nmExperimental Treatment1 Intervention

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.

Group II: Fraxel DUAL 1550 nmExperimental Treatment1 Intervention

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.