Treatment of Androgenetic Alopecia in Females, 12 Beam
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed...
Brief Summary
Official Title: “A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 12 Beam Model For The Treatment of Androgenetic Alopecia in Females”
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 12 beam model for androgenetic alopecia in females when treatment is applied as directed.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: March 2011
Detailed Clinical Trial Description
This is a randomized double-blind, sham controlled clinical study, evaluating changes in terminal hair count in the evaluation zone having evidence of androgenetic alopecia (miniaturized hair).
The trial with 60 female subjects, who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-IV, with classifications of Ludwig I-4, II-1, II-2, or frontal, have active hair loss within the last 12 months.
Subjects will use the device on three non-concurring days a week as directed per device for 26 weeks duration.
Initial efficacy endpoint for each subject will be assessed at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
Intervention(s) in this Clinical Trial
- Device: HairMax LaserComb 2009 model 12 beam
- HairMax LaserComb
- Device: Sham Device
- Sham Device
Arms, Groups and Cohorts in this Clinical Trial
- Sham Comparator: Sham Device
- Sham device
- Active Comparator: LLT Device 2009 12 Beams
- HairMax LaserComb 2009 model 12 beam
Outcome Measures for this Clinical Trial
Primary Measures
- Promotion of hair growth
- Time Frame: 26 weeks
Safety Issue?: No
- Time Frame: 26 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Diagnosis of androgenetic alopecia
- Fitzpatrick Skin types I-IV
- Ludwig I-4, II-1, II-2, or frontal
- Active hair loss within last 12 months
Exclusion Criteria:
- Photosensitivity to laser light
- Malignancy in the target area
- Pregnancy
- Lactating females
Gender Eligibility for this Clinical Trial: Female
Minimum Age for this Clinical Trial: 25 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Investigator Information
Lead Investigator: Lexington International, LLC Industry
Overall Clinical Trial Officials and Contacts
Maria Hordinsky, M.D. Principal Investigator University of Minnesota - Clinical and Translational Science Institute
Related Publications
References
Leavitt M, Charles G, Heyman E, Michaels D. HairMax LaserComb laser phototherapy device in the treatment of male androgenetic alopecia: A randomized, double-blind, sham device-controlled, multicentre trial. Clin Drug Investig. 2009;29(5):283-92.
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01016964
Study ID Number: 12 2009-F-02
ClinicalTrials.gov Identifier: NCT01016964
Health Authority: United States: Institutional Review Board
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01016964
