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

• ClinicalTrials.gov Identifier: NCT01967277
• Recruitment Status: Completed
• First Posted: October 22, 2013
• Results First Posted: May 6, 2015
• Last Update Posted: May 6, 2015
• Sponsor: Capillus, LLC
• Information provided by (Responsible Party): Capillus, LLC

Tracking Information

• First Submitted Date: October 18, 2013
• First Posted Date: October 22, 2013
• Results First Submitted Date: May 5, 2015
• Results First Posted Date: May 6, 2015
• Last Update Posted Date: May 6, 2015
• Study Start Date: March 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 5, 2015)

• 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.

• Original Primary Outcome Measures (submitted: October 21, 2013): Percentage Increase in Terminal Hair Counts from Pre-Treatment, Baseline for active test subjects over the placebo test subjects. [ Time Frame: 16 weeks ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Androgenetic Alopecia

Intervention

• Device: Handi-Dome Laser
  One, 30 minute treatment, every other day for 16 weeks.
• Device: Incandescent red light source.
  One, 30 minute treatment, every other day for 16 weeks.

Study Arms

• 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.
  Intervention: Device: Incandescent red light source.
• Active Comparator: Handi-Dome Laser
  Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.
  Intervention: Device: Handi-Dome Laser

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 21, 2013): 44
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2014
• Actual Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)

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.

-

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01967277
• Other Study ID Numbers: USC650
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Capillus, LLC
• Original Responsible Party: Same as current
• Current Study Sponsor: Capillus, LLC
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Raymond R. Blanche, BA; NST Consulting, LLC

• PRS Account: Capillus, LLC
• Verification Date: May 2015