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Topical Agent

Laser for Male Pattern Baldness

Phase 2
Waitlist Available
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0, week 4(+4), week 8(+4)
Awards & highlights

Study Summary

This trial is testing whether a laser can help a solution of minoxidil 2% grow hair in people with male pattern hair loss.

Eligible Conditions
  • Male Pattern Baldness

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0, week 4(+4), week 8(+4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0, week 4(+4), week 8(+4) 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 in Hair Growth Satisfaction Scale (HGSS)
Change in Investigator Global Assessment of Photography
Hair Growth Assessment (HGA)
+1 more
Secondary outcome measures
Change in Additional Investigator Global Assessment of Photography
Change in Scalp Symptom Assessments

Side effects data

From 2017 Phase 3 trial • 384 Patients • NCT02259088
8%
Upper respiratory tract infection
7%
Nasopharyngitis
6%
Cough
6%
Hypertension
5%
Urinary tract infection
5%
Intraocular pressure increased (Study eye)
4%
Conjunctival haemorrhage (Study eye)
4%
Dry eye (Study eye)
4%
Vitreous haemorrhage (Fellow eye)
3%
Dry eye (Fellow eye)
3%
Anaemia
3%
Hyperlipidaemia
3%
Diabetic nephropathy
2%
Coronary artery disease
2%
Vitreous haemorrhage (Study eye)
1%
Cerebral infarction
1%
Diabetic neuropathy
1%
Angina unstable
1%
Lung infection
1%
Pneumonia
1%
Diabetes mellitus inadequate control
1%
Hypoglycaemia
1%
Cataract (Fellow eye)
1%
Chronic obstructive pulmonary disease
1%
Diabetic vascular disorder
1%
Alanine aminotransferase increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ranibizumab (RFB002)
Laser

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Treatment BExperimental Treatment2 Interventions
Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure At-Home Minoxidil 5%: 2ml of 50mg/ml foam q24 h for duration of study
Group II: Treatment AExperimental Treatment1 Intervention
Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Minoxidil 2%: 2ml of 20mg/ml sterile solution, applied post-laser procedure
Group III: Safety GroupExperimental Treatment4 Interventions
will participate in one visit, receiving laser assisted delivery of minoxidil and PK data. The safety group treatments will follow dose escalation as follows: Safety Participant 1: Post-laser 5mg minoxidil (0.25ml of 20mg/ml sterile solution, applied post-laser procedure) Safety Participant 2: Post-laser 10mg minoxidil (0.5ml of 20mg/ml sterile solution, applied post-laser procedure) Safety Participant 3: Post-laser 20mg minoxidil (1mL of 20mg/mL sterile solution, applied post-laser procedure)
Group IV: PlaceboPlacebo Group1 Intervention
Laser: Fractional ablative, deep mode, 5% fractional coverage Post-Laser Saline 0.9%: 2ml of sterile saline solution applied post-laser procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Laser
2008
Completed Phase 4
~2170

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor
1,379 Previous Clinical Trials
1,588,492 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some dangers associated with Laser treatments?

"Lasers are considered to be a level 2 on our Power scale because, while there is some evidence of safety, none yet exists for efficacy."

Answered by AI

Are there any other scientific papers which mention Laser?

"There are a total of 6 clinical trials studying Laser. Out of those, 2 have progressed to Phase 3 testing. Many of the tests are being conducted in Paramus, New jersey; however, there other centres across America running similar studies."

Answered by AI

Are people still being signed up to participate in this clinical trial?

"As of July 12th, 2022, this study is no longer looking for new candidates. However, there are 93 different trials studying alopecia and 6 more that focus on Laser treatment which are still recruiting patients."

Answered by AI

Does this experiment have an upper age limit for participants?

"To be eligible for this clinical trial, participants must be between the ages of 21 and 65."

Answered by AI

How many participants are you looking for in this experiment?

"Unfortunately, this study is no longer recruiting patients. The posting for the trial was first made on September 30th, 2022 and edited for the last time on July 12th, 2022. There are 93 other studies seeking patients with alopecia and 6 trials involving lasers that are still open to participants."

Answered by AI

Could I qualify to take part in this experiment?

"The purpose of this study is to test a new medication for those with alopecia. To participate, you must be between 21-65 years old and currently suffer from alopecia. There are only 48 positions available."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia
2022. "Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03852992.
~0 spots leftby Apr 2025
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