Trial Outcomes & Findings for Treatment of Androgenetic Alopecia in Males (NCT NCT00947505)

Results Overview

Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

16 and 26 weeks

Results posted on

2012-07-30

Participant Flow

Male subjects who have been diagnosed with androgenetic alopecia, who are between 25 and 60 years of age, have Fitzpatrick Skin Types I-Iv, with Norwood Hamilton Classifications of IIa-V, have active hair loss with the last 12 months

Exclusion Criteria: Individuals with photosensitivity to laser light, histor of any malignancy in target area. Also, use of phytotherapy (e.g. saw palmetto) within 8 weeks prior to baseline and use of retinoids in past year, chronic dermatological condtion (eczema , psoriasis, infection, etc.) of the scalp other than male pattern baldness

Participant milestones

Participant milestones
Measure	LLT Device 2009 7 Beam	Control Device
Overall Study STARTED	33	16
Overall Study COMPLETED	24	14
Overall Study NOT COMPLETED	9	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Androgenetic Alopecia in Males

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LLT Device 2009 7 Beam n=33 Participants	Control Device n=16 Participants	Total n=49 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	16 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants	16 Participants n=7 Participants	49 Participants n=5 Participants

PRIMARY outcome

Timeframe: 16 and 26 weeks

Results of terminal hair count will be compared to baseline for each user between active and control devicea at 26 weeks with an interim evaluation at week 16. Terminal hair count, which is non-vellus/non-miniaturized hair counts, will be assessed in the target region

Outcome measures

Outcome measures
Measure	LLT Device 2009 7 Beam n=24 Participants This is the active LLLT device	Control Device n=14 Participants This is the control device emitting white light
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline Change at 16 weeks	17.7 change in terminal hair count Standard Deviation 12.83	2.8 change in terminal hair count Standard Deviation 6.89
Changes in Terminal Hair Count at 16 and 26 Weeks Over Baseline Change at 26 weeks	18.4 change in terminal hair count Standard Deviation 16.6	1.6 change in terminal hair count Standard Deviation 8.60

Adverse Events

LLT Device 2009 7 Beam

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David Michaels

Lexington International, LLC

Phone: 561-417-0200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place