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Low Level Laser Therapy Device

LaserCaps for Male Pattern Baldness

N/A
Recruiting
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
25 years and older
Be older than 18 years old
Must not have
Women with AGA: Ludwig stage III, advanced
Men with AGA: Norwood stage Va, VI, VII
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to study the effects of low level laser therapy (LLLT) devices on promoting hair growth in individuals with androgenetic alopecia (AGA). The study will compare a low-fl

Who is the study for?
This trial is for men and women aged 25 or older with Androgenetic Alopecia (commonly known as male pattern baldness), who haven't treated it recently, or have stopped previous treatments for at least 6 months. Men should be in the early to moderate stages of hair loss, while women can also join if they're experiencing certain patterns of thinning. Participants must have skin types I to IV according to the Fitzpatrick scale.
What is being tested?
The study tests three different scalp treatments using laser caps: a fake 'Sham' LaserCap that doesn't emit real lasers, a 'LaserCap SD' with low energy emission, and a 'LaserCap HD+' with high energy emission. The goal is to see if higher energy levels from these caps can increase hair density more effectively than lower levels or no treatment.
What are the potential side effects?
Since this trial involves non-invasive laser therapy devices, side effects are expected to be minimal. However, potential side effects might include scalp irritation or redness due to light exposure from the laser devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 25 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a woman with advanced stage hair loss.
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I am a man with advanced hair loss.
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I haven't used treatments for hair loss like minoxidil or finasteride in the last 6 months.
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I am 25 years old or younger.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lasercap SDExperimental Treatment1 Intervention
Low fluence LLLT
Group II: Lasercap HD+Experimental Treatment1 Intervention
High fluence LLLT
Group III: Sham LaserCapPlacebo Group1 Intervention
Sham device

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Who is running the clinical trial?

Transdermal Cap, Inc.Industry Sponsor
University of ArizonaLead Sponsor
539 Previous Clinical Trials
161,626 Total Patients Enrolled
~14 spots leftby Dec 2025
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