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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Incandescent red light source | Placebo Comparator | A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks. |
|
| Handi-Dome Laser | Active Comparator | Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Handi-Dome Laser | Device | One, 30 minute treatment, every other day for 16 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 17 weeks |
| 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. | baseline and 17 weeks |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Raymond R. Blanche, BA | NST Consulting, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bodian Dermatology | Great Neck | New York | 11021 | United States | ||
| Center for Aesthetic Dermatology |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Handi-Dome Laser |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percent change | baseline and 17 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patricia Schnoor | Capillus LLC | 7868881874 | pschnoor@capillus.com |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Incandescent red light source. |
| Device |
One, 30 minute treatment, every other day for 16 weeks. |
|
| Woodbury |
| New York |
| 11797 |
| United States |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | terminal hairs | baseline and 17 weeks |
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| EG001 | 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. | 0 | 22 | 0 | 22 |
PI may not disclose the results of the trial.
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Hair count, difference |
|