Treatment of Androgenetic Alopecia in Females, 9 Beam
This study has been completed.
Sponsor:
Lexington International, LLC
Information provided by (Responsible Party):
Lexington International, LLC
ClinicalTrials.gov Identifier:
NCT00981461
First received: September 21, 2009
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
The purpose of this study is to evaluate the efficacy of the HairMax LaserComb 2009 9 beam model in promoting hair growth in females diagnosed with androgenetic alopecia when treatment is applied as directed.
| Condition | Intervention |
|---|---|
|
Androgenetic Alopecia Hair Loss Female Pattern Baldness |
Device: HairMax LaserComb Device: Control Device |
| 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 |
| Official Title: | A Randomized, Double-Blind Clinical Trial to Evaluate the Safety and Efficacy of the HairMax LaserComb 2009, 9 Beam Model: For the Treatment of Androgenetic Alopecia in Females |
Resource links provided by NLM:
Further study details as provided by Lexington International, LLC:
Primary Outcome Measures:
- Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline [ Time Frame: Baseline, 16 weeks, 26 weeks ] [ Designated as safety issue: No ]The primary analysis of effectiveness was an analysis of covariance, which separately modeled terminal hair count at Week 16 and Week 26 as a function of treatment group (HairMax LaserComb 2009 9 Beam vs.control), study center, age (as a continuous variable), and Fitzpatrick Skin Type classification (as a categorical variable with four levels). The active group was compared to the control device using least squares means with a two-sided test at the 5% level of significance.
| Enrollment: | 72 |
| Study Start Date: | October 2009 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: LLT Device 2009 9 Beam
HairMax LaserComb
|
Device: HairMax LaserComb
Device application 3 times week, for 26 weeks
Other Name: HairMax LaserComb
|
|
Sham Comparator: control device
control device
|
Device: Control Device
Device application 3 times week, for 26 weeks
Other Name: control device
|
Detailed Description:
This is a randomized double-blind, control device clinical study across 5 sites, 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 assess at visit 4 (week 16).
Safety analysis will be assessed based on the reports of adverse events during study.
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981461
Locations
| United States, Florida | |
| Jose Mendez, DO | |
| Miami, Florida, United States, 33144 | |
| Abe Marcadis, MD | |
| Palm Beach, Florida, United States | |
| United States, New Jersey | |
| David Goldberg, MD | |
| Hackensack, New Jersey, United States | |
| United States, New York | |
| Sadick Research Group | |
| New York, New York, United States, 10075 | |
| United States, Virginia | |
| Janet Hickman, MD | |
| Lynchburg, Virginia, United States, 24501 | |
Sponsors and Collaborators
Lexington International, LLC
Investigators
| Principal Investigator: | Michael Jarratt, M.D. | DermaResearch, Inc. |
| Principal Investigator: | Abe Marcadis, M.D. | Palm Beach Research Center |
| Principal Investigator: | David Goldberg, M.D. | Hackensack, NJ |
| Principal Investigator: | Neil S Sadick, MD | Sadick Research Group |
| Principal Investigator: | Jose Mendez, DO | International Dermatology Research, Inc. |
| Principal Investigator: | Janet Hickman, MD | The Education and Researvh Foundation |
More Information
Publications:
| Responsible Party: | Lexington International, LLC |
| ClinicalTrials.gov Identifier: | NCT00981461 History of Changes |
| Other Study ID Numbers: | 151.0805 |
| Study First Received: | September 21, 2009 |
| Results First Received: | April 12, 2012 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Lexington International, LLC:
|
Andregenetic Alopecia Hair Loss Female Pattern Baldness |
Additional relevant MeSH terms:
|
Alopecia Alopecia Areata Hypotrichosis |
Hair Diseases Skin Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 21, 2013