USPlus DERM for Hair Loss

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ablon Skin Institute Research Center

Must not be taking: Rogaine, Nioxin, Finasteride, others

Disqualifiers: Pregnancy, Hair transplant, Alopecia, others

Compensation: Varies

Number of Visits: 4

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness and safety of USPlus DERM softgels for individuals experiencing hair thinning. Participants will take either the actual softgels or a placebo (a pill with no active ingredient) for six months. The trial seeks healthy individuals who have noticed thinning hair and can commit to the study's requirements, such as attending office visits and maintaining their usual hair care routine. As an unphased trial, this study provides participants an opportunity to contribute to early research on potential solutions for hair thinning.

Will I have to stop taking my current medications?

The trial requires that you do not make substantial changes to your current medications during the study. If your doctor advises you to change your medications, you must inform the clinic as soon as possible.

Is there any evidence suggesting that USPlus DERM is likely to be safe for humans?

Research shows that USPlus DERM has been tested for its ability to improve hair growth and scalp health. In one study, participants used a cream version of USPlus DERM for 12 weeks. This study examined hair loss and scalp health but did not report any specific side effects or safety concerns.

While detailed safety information for USPlus DERM in pill form is not yet available, similar hair loss treatments, such as finasteride and minoxidil, are usually well-tolerated. This suggests that USPlus DERM might be safe, though more direct evidence would be beneficial.

As the current trial remains in the early stages, it likely focuses on collecting basic safety and effectiveness information. Participants should consider this when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for hair loss, which often include topical minoxidil or oral finasteride, USPlus DERM is unique because it uses bioactive fatty acids in the form of softgels. These fatty acids are designed to help tackle hair loss from within, offering a novel approach compared to the usual topical applications or hormone-modulating medications. Researchers are excited about USPlus DERM because it could provide an alternative treatment option that is easy to take and may work in harmony with the body’s natural processes to support hair growth.

What evidence suggests that USPlus DERM might be an effective treatment for hair loss?

Research has shown that USPlus DERM may promote hair growth and reduce hair loss. In a recent study, applying USPlus DERM serum (2%) on the scalp led to noticeable improvements in hair growth and thickness for both men and women. Another small study found a significant decrease in hair loss over three months. These results suggest that USPlus DERM could be effective for individuals experiencing thinning hair. The treatment contains special fatty acids believed to support hair health by nourishing the scalp and hair roots. Participants in this trial will receive either USPlus DERM softgels or placebo softgels to evaluate the treatment's effectiveness. ^{2 3 4 5 6}

Who Is on the Research Team?

Glynis Ablon, MD, FAAD, PI

Principal Investigator

Ablon Skin Institute Research Center

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 25-65 who feel their hair is thinning. Participants must be able to attend three office visits, take a phone call, have photos taken of their hair, and complete questionnaires.

Inclusion Criteria

Subjects must be willing to provide verbal understanding and sign required forms approved by the Institutional Review Board

Subjects must be in general good health as determined by the Investigator

Subjects must maintain consistent hair length, cut, style, and color throughout the study period

Exclusion Criteria

Subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study

Subjects who have had a hair transplant or plan to get hair extensions during the study

Subjects with recent stressful incidents, recent hormone use, or recent hair treatments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 phone call

Treatment

Participants receive USPlus DERM or placebo for hair growth over 6 months

24 weeks

3 visits (in-person), 1 phone call

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• USPlus DERM

Trial Overview The study tests USPlus DERM Bioactive Fatty Acids (160 mg softgels) against a placebo to see if it promotes hair growth over six months. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real treatment.

How Is the Trial Designed?

Group I: USPlus DERM softgels Active Control 1 Intervention

USPlus® DERM Bioactive Fatty Acids 160 mg Softgels

Group II: Placebo softgels Placebo Group 1 Intervention

Placebo Softgels

Who Is Running the Clinical Trial?

Ablon Skin Institute Research Center

Lead Sponsor

Trials

8

Recruited

370+

U.S. Nutraceuticals, Inc. dba Valensa International

Collaborator

Published Research Related to This Trial

Dutasteride 0.5 mg, taken daily for 52 weeks, demonstrated long-term safety and tolerability in 120 Japanese male patients with androgenetic alopecia, with mild adverse events like nasopharyngitis and erectile dysfunction reported in 17% of participants, none leading to withdrawal from the study.

The treatment resulted in significant improvements in hair growth, hair restoration, and overall hair appearance by the end of the study, indicating its efficacy as a potential treatment for male pattern hair loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia. Tsunemi, Y., Irisawa, R., Yoshiie, H., et al.[2022]

In a study of 28 breast cancer patients, those treated with CDK4/6 inhibitors (CDKiA) showed a higher prevalence of vertex involvement in alopecia compared to those on endocrine monotherapy, indicating a distinct pattern of hair loss associated with this treatment.

After 4-6 months of minoxidil treatment, 80% of patients with CDKiA experienced moderate to significant improvement in alopecia, although this was less effective than in patients with endocrine-induced alopecia (EIA), suggesting that alternative treatments may be needed for better outcomes in CDKiA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective cohort study of CDK4/6-inhibitor-induced alopecia in breast cancer patients. Minta, A., Rose, L., Park, C., et al.[2023]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06920758

Study Details | NCT06920758 | A 6-month, Randomized, ... The goal of this clinical trial is to substantiate the effectiveness and safety of USPlus® DERM for self-perceived thinning hair compared to ...

2. avensonline.org avensonline.org/wp-content/uploads/JCID-2373-1044-13-0089.pdf

Clinical Outcome of the Topical Application of a Novel Hair ... This 3-month, observational, consumer-use pilot study of USPlus DERM Topical 2% serum found significant improvements in hair loss reduction and ...

3. withpower.com withpower.com/trial/phase-alopecia-11-2024-d2919

USPlus DERM for Hair Loss · Info for Participants After 4-6 months of minoxidil treatment, 80% of patients with CDKiA experienced moderate to significant improvement in alopecia, although this was less ...

4. trial.medpath.com trial.medpath.com/clinical-trial/8fed753a82f8468b/nct06920758-usplus-derm-hair-growth-men-women

A 6-month, Randomized, Double-blind, Placebo Controlled ... The purpose of this clinical research study is to evaluate the efficacy and safety of USPlus® DERM compared to placebo in sixty (60) healthy ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ics.70035?af=R

A proprietary lipidosterolic extract of Serenoa repens ... A recent study demonstrated that topical application of USPlus® DERM serum (2%) improved hair growth and hair density in males and females ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06920758

Study Details | NCT06920758 | A 6-month, Randomized, ... The purpose of this clinical research study is to evaluate the efficacy and safety of USPlus® DERM compared to placebo in sixty (60) healthy ...