Androgenetic Alopecia
Conditions
Brief summary
This study will acquire data on hair growth of the head that is the result of treatment with a non-heat generating, laser product. This data will come from counting of terminal hairs before treatment begins and after treatment is completed. The treatment regime is every other day for 16 weeks.
Detailed description
The purpose of this study is to evaluate the efficacy of Low Level Laser Therapy product that is configured in the novel design of a baseball cap, for promoting hair growth in females diagnosed with genetic hair loss/female pattern hair loss.
Interventions
DEVICEHandi-Dome Laser
One, 30 minute treatment, every other day for 16 weeks.
DEVICEIncandescent red light source.
One, 30 minute treatment, every other day for 16 weeks.
Sponsors
Capillus, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Diagnosis of Androgenetic Alopecia / Female Pattern Hair Loss Fitzpatrick skin phototypes of I - IV Ludwig-Savin Hair Loss scale I - II In overall good health as determined by the physician investigator Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments -
Exclusion criteria
Photosensitivity to the specific wavelength of light - 650 nanometers. Malignancy in the target treatment area Other forms of alopecia of the head Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously affects the scalp. In willingness to remove hair replacement products during the 16 weeks of therapy. Using any medications deemed to inhibit hair growth as determined by the physician investigator. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | baseline and 17 weeks | At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted. |
| Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | baseline and 17 weeks | At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Incandescent Red Light Source Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks. | 22 |
| Handi-Dome Laser Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks. | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | Unrelated illness | 0 | 1 |
Baseline characteristics
| Characteristic | Incandescent Red Light Source | Handi-Dome Laser | Total |
|---|---|---|---|
| Age, Continuous | 49 years | 49.5 years | 49 years |
| Region of Enrollment United States | 22 participants | 22 participants | 44 participants |
| Sex: Female, Male Female | 22 Participants | 22 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Time frame: baseline and 17 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Incandescent Red Light Source | Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | Hair count, difference | 18.5 terminal hairs | Standard Deviation 24.4 |
| Incandescent Red Light Source | Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | Hair count, baseline | 216.9 terminal hairs | Standard Deviation 109.1 |
| Incandescent Red Light Source | Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | Hair count, post treatment | 235.3 terminal hairs | Standard Deviation 105.8 |
| Handi-Dome Laser | Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | Hair count, baseline | 189.3 terminal hairs | Standard Deviation 85.8 |
| Handi-Dome Laser | Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | Hair count, post treatment | 268.3 terminal hairs | Standard Deviation 117.7 |
| Handi-Dome Laser | Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | Hair count, difference | 89.9 terminal hairs | Standard Deviation 63.3 |
Primary
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
At baseline, a 25 mm area of treatment was trimmed of hair (to 3mm) at the vertex of the scalp and photographs were taken, terminal hairs were counted.
Time frame: baseline and 17 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Incandescent Red Light Source | Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | 12.48 percent change | Standard Deviation 13.76 |
| Handi-Dome Laser | Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. | 63.67 percent change | Standard Deviation 50.9 |
Comparison: H0: µL ≤ µs Versus Ha: µL \> µsp-value: <0.001t-test, 2 sided