Clinical trial NCT00981461: Treatment of Androgenetic Alopecia in Females, 9 Beam
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Hair Loss
Female Pattern Baldness
Keywords: Andregenetic Alopecia
Hair Loss
Female Pattern Baldness
Lead sponsor: Lexington International, LLC
Sponsor class: INDUSTRY
First posted: 2009-09-22
Enrollment: 72
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Changes in Terminal Hair Count Week 16 and 26 Weeks Over Baseline
timeFrame: Baseline, 16 weeks, 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jose Mendez, DO
state: Florida
city: Palm Beach
country: United States
facility: Abe Marcadis, MD
state: Florida
city: Hackensack
country: United States
facility: David Goldberg, MD
state: New Jersey
city: New York
country: United States
facility: Sadick Research Group
state: New York
city: Lynchburg
country: United States
facility: Janet Hickman, MD
state: Virginia
Study officials:
affiliation: DermaResearch, Inc.
name: Michael Jarratt, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Palm Beach Research Center
name: Abe Marcadis, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack, NJ
name: David Goldberg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sadick Research Group
name: Neil S Sadick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Dermatology Research, Inc.
name: Jose Mendez, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: The Education and Researvh Foundation
name: Janet Hickman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.2165/00044011-200929050-00001.