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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.

Must not have

Immunosuppression

Participants who have been diagnosed or have a known history of haemostasis disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at visit 8

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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I agree to not change my current hair loss treatment during the study.

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I agree to not change my current hair loss treatment during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am on immunosuppressive therapy.

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I have a bleeding or clotting disorder.

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I have been diagnosed with a blood disorder.

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I am positive for HIV, Hepatitis B, or Hepatitis C.

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I have an active skin infection or inflammation in the area to be treated.

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I have had skin cancer on my scalp before.

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I do not have scalp conditions like eczema, psoriasis, infections, or scars in the treatment area.

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I am currently receiving chemotherapy.

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I am using birth control or am unable to have children due to menopause or surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at visit 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at visit 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at visit 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hair Changes

Scalp Health- ASFS

Scalp Health- Erythema

+1 more

Awards & Highlights

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.

Trial 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

0 / 11Eligibility criteria met