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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment USPlus DERM for hair loss?

The research on topical minoxidil, a treatment for hair loss, shows significant increases in hair counts, suggesting that similar treatments might also be effective for hair loss. ^{1 2 3 4 5}

Is USPlus DERM safe for treating hair loss?

While specific safety data for USPlus DERM is not available, similar treatments like finasteride and minoxidil have been studied. Finasteride has been associated with depression, sexual dysfunction, and reproductive toxicity, while minoxidil can cause scalp irritation. Dutasteride, another similar treatment, showed mild adverse effects like nasopharyngitis and erectile dysfunction in a study. ^{6 7 8 9 10}

How does the treatment USPlus DERM for hair loss differ from other treatments?

USPlus DERM is unique because it may involve a novel combination of ingredients or a new mechanism of action, such as inhibiting 5-α-reductase activity, reducing inflammation, and stimulating extracellular matrix protein synthesis, which are not commonly addressed by standard treatments like minoxidil or finasteride. ^{2 5 11 12 13}

What is the purpose of this trial?

The goal of this clinical trial is to substantiate the effectiveness and safety of USPlus® DERM for self-perceived thinning hair compared to placebo in healthy men and women ages 25-65 over the course of six months of continued use. Participants will be asked to have attend three office visits, one phone call, have photos taken of their hair and answer questionnaires related to their thinning hair.

Research Team

Glynis Ablon, MD, FAAD, PI

Principal Investigator

Ablon Skin Institute Research Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Androgenetic alopecia: treatment results with topical minoxidil. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

New Treatments for Hair Loss. [2018]

3. United States pubmed.ncbi.nlm.nih.gov

What's New in Hair Loss. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The Hairdex quality of life instrument-A translation and psychometric validation in patients with alopecia areata. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review of the Outcome of Hair Transplantation in Primary Scarring Alopecia. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Finasteride and Suicide: A Postmarketing Case Series. [2021]

7. United States 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). [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Retrospective cohort study of CDK4/6-inhibitor-induced alopecia in breast cancer patients. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of dutasteride in the treatment of male patients with androgenetic alopecia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Differences in reproductive toxicology between alopecia drugs: an analysis on adverse events among female and male cases. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Hair loss]. [2013]

12. United States pubmed.ncbi.nlm.nih.gov

A new strategy to modulate alopecia using a combination of two specific and unique ingredients. [2013]

13. United States pubmed.ncbi.nlm.nih.gov

A Survey of Patient Attitudes Towards Topical Minoxidil in the Treatment of Hair Loss. [2022]