Hydraderm for Male Pattern Baldness

Overseen By Irmina Wallander

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Must be taking: Alopecia treatments

Disqualifiers: Skin conditions, Autoimmune diseases, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new scalp treatment called Venus Glow (also known as Hydradermabrasion) for individuals with male pattern baldness. The goal is to determine if this treatment can improve scalp health and promote hair growth. It suits healthy men and women who have experienced male pattern baldness and have not changed their hair loss treatment in the last four months. Participants must continue using the same hair treatment and shampoo throughout the study. Participation involves several treatment sessions and a follow-up visit to track results. As a Phase 4 trial, this treatment has already received FDA approval and proven effective, offering participants the chance to benefit from a well-established therapy.

Do I have to stop taking my current medications?

No, you must continue your current treatment for androgenetic alopecia throughout the study without any changes.

What is the safety track record for Venus Glow?

Research has shown that Venus Glow, a treatment for skin cleansing, is safe for use on the scalp. This treatment enhances blood flow to the scalp, potentially supporting hair growth. It is approved for this purpose and does not leave visible scars, making it a gentle option.

While specific safety data for treating male pattern baldness is lacking, individuals can quickly resume normal activities after the treatment, suggesting it is generally well-tolerated. This information may reassure those considering participation in a clinical trial for this treatment. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for male pattern baldness, which often involve medications like finasteride and minoxidil, Venus Glow offers a unique, non-invasive approach. This treatment is distinctive because it utilizes a hydradermabrasion technique, which combines cleansing and exfoliation with the infusion of serums directly into the scalp. Researchers are excited about Venus Glow because it has the potential to stimulate hair growth by improving scalp health, possibly offering a fresh alternative for those seeking non-drug interventions.

What evidence suggests that hydradermabrasion is effective for male pattern baldness?

Research has shown that hydradermabrasion, particularly with the Venus Glow device, might improve scalp health and support hair growth in individuals with male pattern baldness. Studies have found that hydradermabrasion can enhance scalp health, potentially aiding hair growth. While direct evidence on Venus Glow's effect on hair growth is limited, its method of cleaning and nourishing the scalp appears promising. This treatment is minimally invasive, requiring no surgery and allowing for quick recovery. Venus Glow leaves no visible scars, enabling a swift return to normal activities. ^{1 2 3 4 5}

Who Is on the Research Team?

Ronda Farah, MD

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Participants who agree to be photographed for research purposes and their identity may not be concealed in these photographs.

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.

Exclusion Criteria

I am on immunosuppressive therapy.

Participants who are pregnant, planning to become pregnant or breastfeeding. A urine pregnancy test will be done to rule out pregnancy

Non-English speakers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hydradermabrasion treatment on the scalp to improve scalp health and hair growth

16 weeks

4 sessions at 1-week intervals, followed by 3 sessions each 4 weeks apart

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• Venus Glow

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 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

Venus Glow is already approved in United States, Canada for the following indications:

Approved in United States as Venus Glow for:

• Skin rejuvenation
• Deep pore cleansing
• Acne treatment
• Anti-aging

Approved in Canada as Venus Glow for:

• Skin rejuvenation
• Deep pore cleansing
• Acne treatment
• Anti-aging

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

A study of 50 cosmetic products containing alpha hydroxy acids (AHAs) found that 19 exceeded the recommended maximum concentration of 10%, raising safety concerns for consumers.

Only 16 out of 50 products included necessary sunburn alerts, highlighting a lack of compliance with FDA guidelines and the need for better consumer information regarding the use of AHAs in cosmetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Are cosmetics based on alpha hydroxy acids safe to use when purchased over the internet? Krstonošić, V., Ćirin, D.[2022]

Between 2004 and 2017, 41% of all adverse events related to cosmetics reported to the FDA were cancer-related, totaling 4427 reports, with a significant number linked to ovarian cancer and talc powders.

The current data from the FDA's adverse event reporting system is limited due to high rates of redaction and potential reporter bias, indicating a need for improved reporting practices and regulatory science to better assess the safety of cosmetic products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cosmetics and Cancer: Adverse Event Reports Submitted to the Food and Drug Administration. Jacob, SL., Cornell, E., Kwa, M., et al.[2023]

Men are increasingly seeking cosmetic procedures due to societal pressures and the desire to maintain a youthful appearance, yet there is limited research on laser and light treatments specifically for male skin.

The review highlights unique male skin conditions, such as pseudofolliculitis barbae and rhinophyma, and discusses the need for more focused studies on the efficacy of laser treatments for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laser and Light-Based Aesthetics in Men. Green, JB., Metelitsa, AI., Kaufman, J., et al.[2015]

Male pattern baldness affects up to 50% of adult males, with treatments like minoxidil (Rogaine) gaining popularity over the past decade.

The article reviews the causes of male pattern baldness and discusses current and future treatment options, highlighting the growing interest in addressing this common condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Male pattern baldness. Duplechain, G., White, JA.[2013]

Scrotal rejuvenation, which addresses issues like hair loss, wrinkling, and vascular changes, is gaining attention but lacks the extensive research seen in vaginal rejuvenation, indicating a need for more studies in this area.

Potential treatments for scrotal rejuvenation include medical therapies like minoxidil for hair loss, laser treatments for skin issues, and surgical options for laxity, suggesting a variety of approaches to improve scrotal appearance and health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scrotal Rejuvenation. Cohen, PR.[2020]

Testosterone replacement therapy (TRT) using Glowmin ointment significantly improved symptoms related to late onset hypogonadism (LOH) in 41 patients over a 3-month period, including erectile dysfunction and overall health scores.

The therapy notably enhanced lower urinary tract symptoms (LUTS), particularly improving voiding disturbances more than storage disturbances, indicating its efficacy in addressing multiple symptoms associated with LOH.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testosterone replacement therapy by testosterone ointment relieves lower urinary tract symptoms in late onset hypogonadism patients. Amano, T., Imao, T., Takemae, K., et al.[2013]

Transdermal testosterone patches have been shown to effectively improve symptoms of low testosterone in aging males, such as erectile dysfunction and loss of muscle mass, over long-term use of 3 to 10 years.

The new topical gel formulation, Testim, offers a consistent delivery of testosterone over 24 hours, and short-term studies suggest it does not increase the risk of prostate cancer, making it a safer option for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New advances in the treatment of hypogonadism in the aging male. Steidle, CP.[2020]

Oral contraceptive pills (OCPs) are effective for treating mild hirsutism, while flutamide and spironolactone are recommended for more severe cases, indicating a range of treatment options based on severity.

Finasteride and gonadotropin-releasing analogues show inconsistent results, and metformin does not provide any benefit for hirsutism, highlighting the importance of choosing the right therapy for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for Hirsutism. van Zuuren, EJ., Fedorowicz, Z.[2018]

The new hair-lifting technique for treating male-pattern alopecia involves removing segments of bald skin and lifting existing hair into the bald areas, which can also provide a partial face-lift benefit.

This procedure is performed in stages under local anesthesia and is particularly effective for specific types of baldness, such as tonsure baldness in men and skull-cap androgenic alopecia in women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obliteration of alopecia by hair-lifting: a new concept and technique. Blanchard, G., Blanchard, B.[2018]

A study involving 4373 participants in Naples found that 19.4% of cosmetic users reported experiencing at least one adverse cosmetic event (ACE), with a higher prevalence in women (26.5%) compared to men (17.4%).

The majority of reported adverse events were cutaneous reactions (95.9%), with burning and itching being the most common symptoms, while only a small percentage of individuals sought professional help, highlighting the need for better reporting and evaluation systems for cosmetic-related injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cosmetovigilance survey: are cosmetics considered safe by consumers? Di Giovanni, C., Arcoraci, V., Gambardella, L., et al.[2022]

Minoxidil is an effective topical treatment for male pattern baldness, particularly beneficial for young men who are just starting to experience hair loss, as it has been extensively studied and shown to improve hair growth at the vertex of the scalp.

Hair loss can result from various causes, including hormonal imbalances and systemic diseases, and addressing these underlying issues can help reduce hair shedding, while surgical options are available for more severe cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hair loss. What causes it and what can be done about it. Burke, KE.[2019]

Cetosomal minoxidil 5% was found to be effective in treating androgenetic alopecia (AGA), with 52% of patients showing significant to excellent improvement after 16 weeks, compared to 68% in the combination group with finasteride.

The cetosomal formulation demonstrated good tolerability, with 64% of patients rating it as excellent, suggesting it may be a safer alternative to traditional alcoholic minoxidil solutions, which are often associated with adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Effectiveness, Safety, and Tolerability of Cetosomal Minoxidil 5% Alone and a Fixed Drug Combination of Cetosomal Minoxidil 5% With Finasteride 0.1% in the Management of Androgenetic Alopecia (Inbilt Study). Kerure, A., Ghalla, M., Mahajan, S., et al.[2023]

Oral dutasteride (OD) is an effective treatment for male androgenetic alopecia, with 90% of patients showing improvement after 12 months of treatment, particularly in those receiving it as monotherapy.

The safety profile of OD is favorable, with only 2.6% of patients experiencing adverse effects, which resolved after discontinuation of the drug, and no adverse effects reported in those on low doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and safety of oral dutasteride for male androgenetic alopecia in real clinical practice: A descriptive monocentric study. Vañó-Galván, S., Saceda-Corralo, D., Moreno-Arrones, OM., et al.[2020]

The TRICHOBIOLIGHT protocol, which combines mesotherapy with LED light treatment, showed excellent to good outcomes in 82.5% of the 103 patients treated for androgenetic alopecia and related hair loss conditions.

This innovative approach not only strengthens and thickens existing hair but also provides significant aesthetic and psychological benefits, enhancing the quality of life for those affected by hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trichobiolight: A new, effective protocol in the treatment of androgenetic alopecia and telogen effluvium. Piccolo, D., Crisman, G., Conforti, C., et al.[2021]

A 46-year-old woman with androgenic alopecia showed significant improvement after switching from finasteride to dutasteride, a different 5-reductase inhibitor, after 6 months of treatment.

Dutasteride was effective in this case without any observed side effects, suggesting it could be a promising alternative for treating androgenic alopecia, especially in patients who do not respond to other treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective treatment of female androgenic alopecia with dutasteride. Olszewska, M., Rudnicka, L.[2015]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05426629

NCT05426629 | Hydraderm for Androgenic Alopecia The study aims to assess the effect of this treatment on scalp health and hair growth. Official Title. The Use of Hydradermabrasion in the Scalp to Improve ...

2. withpower.com withpower.com/trial/phase-4-alopecia-areata-2-2022-0403a

Hydraderm for Male Pattern Baldness · Info for Participants Oral dutasteride (OD) is an effective treatment for male androgenetic alopecia, with 90% of patients showing improvement after 12 months of treatment, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11328498/

Clinical and preclinical approach in AGA treatment The efficacy of ASCs-CM was further evaluated in a study with 38 participants over 16 weeks, showing a significant increase in hair count and ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05426629/hydraderm-for-androgenic-alopecia

Hydraderm for Androgenic Alopecia | Clinical Research ... The study will be focused on evaluating the use of hydradermabrasion on the scalp. The study aims to assess the effect of this treatment on ...

5. venusconcept.com venusconcept.com/en-ie/hair-restoration-treatment.htm

Hair Restoration Treatment Devices | Venus Concept Venus Concept's hair loss solutions leave no visible linear scar, are minimally invasive, and patients can return to their routine within the same week.