Trial Outcomes & Findings for Fractional Photothermolysis for Hair Follicle Induction (NCT NCT03382184)
NCT ID: NCT03382184
Last Updated: 2026-03-03
Results Overview
Hair density will be measured as increased or decreased before and after treatment using dermoscopy on both the treated and untreated scalp.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
24 weeks
Results posted on
2026-03-03
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
Halo laser: The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
0
|
|
Overall Study
COMPLETED
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fractional Photothermolysis for Hair Follicle Induction
Baseline characteristics by cohort
| Measure |
Fraxel DUAL 1550 nm
n=5 Participants
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.
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.
|
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.
Halo laser: The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=41 Participants
|
—
|
5 Participants
n=76 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Age, Continuous
|
32 years
n=41 Participants
|
—
|
32 years
n=76 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=41 Participants
|
—
|
1 Participants
n=76 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=41 Participants
|
—
|
4 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=41 Participants
|
—
|
5 Participants
n=76 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=41 Participants
|
—
|
3 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
—
|
0 Participants
n=76 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=41 Participants
|
—
|
2 Participants
n=76 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=41 Participants
|
—
|
5 participants
n=76 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Hair density will be measured as increased or decreased before and after treatment using dermoscopy on both the treated and untreated scalp.
Outcome measures
| Measure |
Fraxel DUAL 1550 nm
n=5 Participants
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.
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.
|
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.
Halo laser: The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.
|
|---|---|---|
|
Hair Density Change by as Seen by Dermoscopy
Hair density increased
|
5 Participants
|
—
|
|
Hair Density Change by as Seen by Dermoscopy
Hair density decreased
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Hair density will be measured as increased or decreased before and after treatment using OCT on both the treated and untreated scalp.
Outcome measures
| Measure |
Fraxel DUAL 1550 nm
n=5 Participants
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.
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.
|
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.
Halo laser: The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.
|
|---|---|---|
|
Hair Density Change as Seen by Optical Coherence Tomography (OCT).
Hair density decreased
|
0 Participants
|
—
|
|
Hair Density Change as Seen by Optical Coherence Tomography (OCT).
Hair density increased
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: 24 weeksPopulation: Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
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).
Outcome measures
| Measure |
Fraxel DUAL 1550 nm
n=5 Participants
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.
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.
|
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.
Halo laser: The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.
|
|---|---|---|
|
Hair Regrowth Impact on Quality of Life (Improved or Not Improved)
|
3.4 units on a scale
Standard Deviation 0.55
|
—
|
Adverse Events
Halo Hybrid Laser 1550 nm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fraxel DUAL 1550 nm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Natasha Mesinkovska, MD, PhD, Associate Professor, Dermatology
University of California, Irvine
Phone: 949-824-5515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place