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A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Capillus, LLC
ClinicalTrials.gov Identifier:
NCT01967277
First received: October 18, 2013
Last updated: May 5, 2015
Last verified: May 2015
  Purpose
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.

Condition Intervention
Androgenetic Alopecia
Device: Handi-Dome Laser
Device: Incandescent red light source.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Novel Approach to Treating Androgenetic Alopecia in Females With Low Level Laser Therapy

Resource links provided by NLM:


Further study details as provided by Capillus, LLC:

Primary Outcome Measures:
  • Percentage Increase in Terminal Hair Counts From Pre-Treatment, Baseline for Active Test Subjects Over the Placebo Test Subjects. [ Time Frame: 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. [ Time Frame: 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.


Enrollment: 44
Study Start Date: March 2014
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Incandescent red light source
A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.
Device: Incandescent red light source.
One, 30 minute treatment, every other day for 16 weeks.
Active Comparator: Handi-Dome Laser
Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
Device: Handi-Dome Laser
One, 30 minute treatment, 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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967277

Locations
United States, New York
Bodian Dermatology
Great Neck, New York, United States, 11021
Center for Aesthetic Dermatology
Woodbury, New York, United States, 11797
Sponsors and Collaborators
Capillus, LLC
Investigators
Study Director: Raymond R. Blanche, BA NST Consulting, LLC
  More Information

Responsible Party: Capillus, LLC
ClinicalTrials.gov Identifier: NCT01967277     History of Changes
Other Study ID Numbers: USC650
Study First Received: October 18, 2013
Results First Received: May 5, 2015
Last Updated: May 5, 2015

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on March 24, 2017