A 6-month, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of USPlus DERM to Promote Hair Growth in Men and Women With Self-perceived Thinning Hair.

Launched by ABLON SKIN INSTITUTE RESEARCH CENTER · Apr 3, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating the effectiveness and safety of a product called USPlus® DERM to help promote hair growth in men and women who feel their hair is thinning. The study will last for six months, and participants will need to attend three office visits, have some photos taken of their hair, and complete questionnaires about their experience with hair thinning. To be eligible, participants must be healthy adults aged 25 to 65 who notice their hair thinning but do not have a medical diagnosis related to hair loss.

Those who join the study can expect regular check-ins and will be asked to follow specific instructions regarding their hair care and overall health routines during the trial. It's important to note that participants should not make significant changes to their diet or medications during this time. Additionally, women who can become pregnant will need to take a pregnancy test and use effective birth control throughout the study. This trial is currently active but is not recruiting new participants at this time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy males and females of all Fitzpatrick Skin Types between 25 and 65 years of age.
• • 2. Subjects must be willing to provide verbal understanding and sign an Informed Consent Form, HIPAA Form and Photography Release Form approved by the Institutional Review Board.
• • 3. Subjects must be in general good health, as determined by the Investigator.
• • 4. Subjects with self-perceived hair thinning as determined on initial study assessment by the Investigator (excluding patients with medically diagnosed telogen effluvium).
• • 5. Subjects willing to undergo a brief physical exam to include height, weight, blood pressure, pulse, physical scalp exam and basic systems evaluation (Skin, Respiratory, Cardiovascular, Gastrointestinal, Endocrine, Neurological and Musculoskeletal systems) by the Investigator.
• • 6. Male subjects with frontal and/or vertex patterns I, II, IIA, III, III vertex and IV during the physical scalp exam by the Investigator rated based on the Norwood Classification Scale.
• • 7. Female subjects with I-1, I-2 and I-3 during the physical scalp exam by the Investigator rated based on the Savin Pictorial Scale.
• • 8. Subjects willing to not substantially change their current diet, medications, dietary supplements and exercise routines for the duration of the study. If a subject receives physician guidance during the study to change diet, medications, supplements or exercise routine, the subject will need to notify the clinic as soon as possible.
• • 9. Females of child bearing potential (FOCBP) must be willing to have a urine pregnancy test and practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months as of the start of the study, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing®, injection, transdermal patch or abstinence.) Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study. Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study. The initiation of birth control should not have been associated with the initiation of hair loss/thinning.
• • 10. FOCBP must have a negative urine pregnancy test at the Baseline Visit.
• • 11. Subjects willing to have 2-D digital photography of the entire head/hair region for overall evaluation of general hair growth and quality by the Investigator.
• • 12. Subjects willing to have digital trichoscopy photography of the target site areas on the scalp for analysis of hair counts and other hair measurements.
• • 13. Subjects must be willing and able to complete and understand the rating questionnaires.
• • 14. Subjects must maintain a consistent length, cut, style and color throughout the six (6) month study period.
• • 15. Subjects who have color treated hair must be willing to have the color treatment performed at the same time interval prior to each visit (i.e. If on Visit 1 the color treatment was done one week prior then the color treatment is expected to occur at a similar interval of one week prior to Visits 2 and 3).
• • 16. Subjects willing to maintain their normal hair shampooing frequency, use a mild non-medicated shampoo and conditioner for the duration of the study and attend visits with clean and dry hair (shampoo must be done 24 hours or more prior to the visit).
• • 17. Subjects must be willing and able to attend all study visits and comply with the study product daily usage and lifestyle instructions.
• Exclusion Criteria:
• • 1. Subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study.
• • 2. Male subjects with male pattern hair loss with frontal and/or vertex patterns IIIA, IVA, V, VA, VI, VII ratings using the Norwood Classification Scale as determined during the physical scalp exam by the Investigator.
• • 3. Female subjects with I-4, II-1,II-2, III Advanced and Frontal ratings using the Savin Pictorial Scale as determined during the physical scalp exam by the Investigator.
• • 4. Subjects who have had a hair transplant.
• • 5. Subjects with hair extensions or who are planning on getting hair extensions during the duration of the study.
• • 6. Subjects with any known allergy or sensitivity to any shampoo and/or conditioner.
• • 7. Subjects with a known stressful incident within the last six months (e.g. death in family, miscarriage).
• • 8. Subjects who have recently (within the last 3 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (3 months or longer) in order to be eligible for the study.
• • 9. Subjects using Low Level Laser Therapy (LLLT) or other light therapy to treat thinning hair in the last 3 months.
• • 10. Subjects who have regularly used Rogaine (Minoxidil), Nioxin and /or Finasteride or undergone any other hair or scalp treatments within the last 3 months.
• • 11. Subjects who have used prescription drugs known to affect the hair growth cycle within the last 3 months (e.g., hormone-based birth control for less than 3 months, cyproterone acetate, aldactone/spironolactone or any 5-alpha-reductase inhibitor).
• • 12. Subjects who have regularly used anti-androgenic therapies (i.e. spironolactone, flutamide, cyproterone acetate, progesterone and/or bicalutamide) or undergone any other hair or scalp treatments within the last 3 months.
• • 13. Subjects suffering from other hair loss disorders, such as alopecia areata, scarring alopecia, androgenetic alopecia and telogen effluvium as determined during initial study assessment and physical scalp exam by the Investigator.
• • 14. Subjects with self-reported uncontrolled diseases (i.e. diabetes, hypertension, hyperthyroidism, hypothyroidism, etc.). Whether medical conditions are under control with or without treatment will be assessed on an individual basis by the Investigator based on her medical and clinical expertise.
• • 15. Subjects with self-reported active hepatitis, immune deficiency, HIV or autoimmune disease.
• • 16. Subjects having a known active dermatologic condition of the scalp that may place the subject at a greater risk or interfere with clinical evaluations (ie. seborrheic dermatitis, psoriasis, atopic dermatitis, advanced skin cancer, etc.) as determined by the Investigator based on her medical and clinical expertise.
• • 17. Subjects who are unable to communicate or cooperate with the Investigator due to language problems, poor mental development, or impaired cerebral function.
• • 18. Subjects with any underlying disease that the Investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.
• • 19. Subjects with use of any medications that are known to potentially cause hair loss or affect hair growth as determined by the Investigator based on her medical and clinical expertise.