Back to resultsA Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
Primary Purpose
Androgenetic Alopecia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Handi-Dome Laser
Incandescent red light source.
Sponsored by
About this trial
This is an interventional treatment trial for Androgenetic Alopecia
Eligibility Criteria
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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Sites / Locations
- Bodian Dermatology
- Center for Aesthetic Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Incandescent red light source
Handi-Dome Laser
Arm Description
A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01967277
Brief Title
A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
Official Title
A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capillus, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Androgenetic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Incandescent red light source
Arm Type
Placebo Comparator
Arm Description
A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Arm Title
Handi-Dome Laser
Arm Type
Active Comparator
Arm Description
Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Intervention Type
Device
Intervention Name(s)
Handi-Dome Laser
Intervention Description
One, 30 minute treatment, every other day for 16 weeks.
Intervention Type
Device
Intervention Name(s)
Incandescent red light source.
Intervention Description
One, 30 minute treatment, every other day for 16 weeks.
Primary Outcome Measure Information:
Title
Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Description
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
Title
Absolute Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects.
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond R. Blanche, BA
Organizational Affiliation
NST Consulting, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Bodian Dermatology
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Center for Aesthetic Dermatology
City
Woodbury
State/Province
New York
ZIP/Postal Code
11797
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
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