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Device

iRestore Hair Rejuvenation System for Male Pattern Baldness

N/A
Waitlist Available
Led By Jonathan Dosik, MD
Research Sponsored by Freedom Laser Therapy, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week 4, week 12, and week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee
Awards & highlights

Study Summary

The purpose of this study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia

Eligible Conditions
  • Male Pattern Baldness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week 4, week 12, and week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 4, week 12, and week 24 subjects will have their scalp evaluated by the dermatologist or a trained designee for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Screening/Baseline Hair Growth at Week 12 and Week 24
Secondary outcome measures
Visual Scalp Assessment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: iRestore Hair Rejuvenation SystemExperimental Treatment1 Intervention
Seventy six (76) subjects will be enrolled in the 24-week study; of which 38 will be male and 38 will be female using the iRestore hair growth device
Group II: Sham Device ArmPlacebo Group1 Intervention
This study arm will use a sham device consistent with the experimental device with 12 men and 12 women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days

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Who is running the clinical trial?

Freedom Laser Therapy, Inc.Lead Sponsor
1 Previous Clinical Trials
40 Total Patients Enrolled
TKL Research, Inc.Industry Sponsor
19 Previous Clinical Trials
1,597 Total Patients Enrolled
Jonathan Dosik, MDPrincipal InvestigatorTKL Research, Inc.
2 Previous Clinical Trials
100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness
2012. "24 Week Clinical Trial to Evaluate Safety and Effectiveness of a Hair Growth System to Treat Male and Female Baldness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01686295.
All > Androgenetic Alopecia
~8 spots leftby May 2025
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