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Hydraderm for Male Pattern Baldness
Phase 4
Recruiting
Led By Ronda Farah
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments.
Participants who agree to continue their same treatment they are on at the baseline visit for androgenetic alopecia, for the entire duration of the study without plans to stop, change or add additional treatments
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at visit 8
Awards & highlights
Study Summary
This trial will study the effects of a hydradermabrasion treatment on the scalp. The goal is to see if it improves scalp health and hair growth.
Who is the study for?
This trial is for men and women aged 18-65 with male pattern baldness who can consent to the study, follow instructions, attend visits, be photographed without identity concealment, and maintain their current hair loss treatment. Excluded are those with scalp conditions/infections/cancers, autoimmune or blood disorders, recent scalp procedures, immunosuppression, non-English speakers or pregnant/breastfeeding individuals.Check my eligibility
What is being tested?
The trial tests hydradermabrasion (Venus Glow) on the scalp to evaluate its effects on scalp health and hair growth in individuals with androgenic alopecia. Participants will receive this non-invasive treatment while continuing their existing hair loss treatments.See study design
What are the potential side effects?
While not explicitly listed in the provided information, potential side effects of hydradermabrasion may include temporary redness or irritation at the treatment site. As a non-invasive procedure it's generally considered safe with minimal risks.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to not change my current hair loss treatment during the study.
Select...
I agree to not change my current hair loss treatment during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at visit 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at visit 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hair Changes
Scalp Health- ASFS
Scalp Health- Erythema
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
4 sessions of treatment at 1-week interval for first 4 weeks 3 sessions of treatment each 4 weeks apart, at week 8, week 12 and week 16
1 Follow-up visit: Follow up 4 weeks after the last treatment at week 20
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venus Glow
2023
N/A
~40
Find a Location
Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,381 Previous Clinical Trials
1,588,735 Total Patients Enrolled
Ronda FarahPrincipal InvestigatorUniversity of Minnesota
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am on immunosuppressive therapy.I have a bleeding or clotting disorder.I have been diagnosed with a blood disorder.I am between 18 and 65 years old and in good health.I agree to not change my current hair loss treatment during the study.I understand the study, can follow instructions, and will attend all required visits.I am positive for HIV, Hepatitis B, or Hepatitis C.I have an active skin infection or inflammation in the area to be treated.I have had a skin biopsy or procedure on my scalp in the last month.You have been diagnosed with an autoimmune disease.You have a current severe skin allergy.I have had skin cancer on my scalp before.I do not have scalp conditions like eczema, psoriasis, infections, or scars in the treatment area.You have male or female pattern baldness.I am currently receiving chemotherapy.I haven't changed my hair loss treatment in the last 4 months.You have a medical device implanted near the area where the treatment will be given.I am using birth control or am unable to have children due to menopause or surgery.I agree to not change my current hair loss treatment during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Male Pattern Baldness Patient Testimony for trial: Trial Name: NCT05426629 — Phase 4
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being monitored in this research project?
"Affirmative. According to clinicaltrials.gov, this experiment has been open for recruitment since March 14th 2022 and was recently updated on June 20th 2022. The research is enrolling 40 participants from a single medical setting."
Answered by AI
Are there any active openings for participants to join this research?
"According to the clinicaltrials.gov database, this research programme is still accepting participants; it was first made available on March 14th 2022 and has received a recent update as of June 20th 2022."
Answered by AI
Will persons younger than 80 years be considered for involvement in this research?
"The criteria for enrollment into this clinical trial includes a minimum age of 18 and an upper limit of 65."
Answered by AI
Are there any health risks associated with using Venus Glow?
"Evidence from the Phase 4 trial demonstrates that Venus Glow is safe, thereby assigning it a score of 3."
Answered by AI
Who would be most suitable to enroll in this medical experiment?
"This clinical trial seeks 40 adults (18-65 years) who suffer from alopecia and meet the following criteria: comprehension of study guidelines, voluntary provision of written consent including HIPAA compliance, current treatment for alopecia with no plans to change it during the course of the trial, agreement to be photographed without concealment for research purposes, commitment to use one specific shampoo throughout the duration."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Oregon
Minnesota
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
University of Minnesota
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I've been experiencing hair thinning and hair loss and I would like to act before it gets too late.
PatientReceived 1 prior treatment
I have suffered with female artery hair loss and I would like to find a solution and help others who are suffering.
PatientReceived 2+ prior treatments
Just interested in clinical trials that could help me in my quest to reverse half a lifetime of male pattern baldness.
PatientReceived 2+ prior treatments
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