A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy
1 other identifier
interventional
44
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2013
CompletedFirst Posted
Study publicly available on registry
October 22, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2014
CompletedResults Posted
Study results publicly available
May 6, 2015
CompletedMay 6, 2015
May 1, 2015
5 months
October 18, 2013
May 5, 2015
May 5, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Incandescent red light source
PLACEBO COMPARATORA 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 COMPARATORStudy subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Interventions
One, 30 minute treatment, every other day for 16 weeks.
Eligibility Criteria
You may qualify if:
- 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 -
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Capillus, LLClead
Study Sites (2)
Bodian Dermatology
Great Neck, New York, 11021, United States
Center for Aesthetic Dermatology
Woodbury, New York, 11797, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Patricia Schnoor
- Organization
- Capillus LLC
Study Officials
- STUDY DIRECTOR
Raymond R. Blanche, BA
NST Consulting, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2013
First Posted
October 22, 2013
Study Start
March 1, 2014
Primary Completion
August 1, 2014
Study Completion
September 1, 2014
Last Updated
May 6, 2015
Results First Posted
May 6, 2015
Record last verified: 2015-05