Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:18 AM
Ignite Modification Date:
2025-12-25 @ 12:18 AM
NCT ID:
NCT06920758
Brief Summary:
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.
Detailed Description:
Hair shedding and thinning is presenting at alarming rates. It affects over 80% of men and 50% of women in the United States alone. As a multifactorial condition, while genetics is a small component, change in environmental exposures, nutrition, hormones, stress and lifestyle play significant roles. Currently, many individuals are looking for natural or prescription free options to combat challenges in hair thinning. One of the main ingredients added to current formulations is the natural supplement Saw Palmetto (Serenoa repens). To maintain thick full hair takes work, and prevention of hair thinning, shedding and hair loss requires early intervention. This study is performed to demonstrate the success of a long-standing supplement in the hair loss treatment armamentarium.
Oral medications come with significant side effects, and other modalities like laser and platelet rich plasma can be expensive to afford. Supplements therefore become a great natural alternative. Saw palmetto or Serenoa repens is a plant from the Areaceae family also known as Sabal serrulataa that acts as a competitive nonselective inhibitor of 5-alpha reductase (5αR) types I and II, which blocks the conversion of testosterone to its active metabolite, dihydrotestosterone. This process has been shown to help prevent miniaturization of hairs that lead to hair loss. Valensa International has analyzed the vast amount of science, as well as their own research data, to understand the impact of USPlus® DERM which contains concentrated lipidosterolic extracts of saw palmetto on hair health. The mechanism of action appears to prolong the anagen phase, tends to enhance dermal papilla, and maintains the follicle stem cell niche. USPlus® DERM is concentrated in bioactive free fatty acids (the building blocks of hair) and can help benefit hair health, the hair growth cycle and hair characteristics. Since hair loss has a multifactorial etiology, studying USPlus® DERM in the treatment
The purpose of this clinical research study is to evaluate the efficacy and safety of USPlus® DERM compared to placebo in sixty (60) healthy male and female subjects, 25-65 years of age with self-perceived hair thinning over the course of six (6) months of continued use.
Pre-Study Procedures
1. Candidate subjects will be screened with selected eligibility requirements by telephone prior to Visit 1. The questions include the following: (1) Are you between the ages of 25-65? (2) Do you feel that your hair is thinning? 3) Are you able to attend periodic visits at your study doctor's office (3 visits and one phone call over a 6 month period)?
2. Candidate subjects will be assigned an appointment time for visiting the clinic.
VISIT PROCEDURES
Visit 1: Baseline, Day 0
1. Individuals will be given an informed consent form (ICF) document, HIPAA form and Photography release form to read. They will have all of their study related questions answered by the Investigator and if they agree, they will sign the ICF, HIPAA and Photography release forms. Subjects will be given one copy of the signed ICF, HIPAA and Photography release forms to keep. The original documents will remain at Ablon Skin Institute and Research Center in the subject's file.
2. Investigator and/or Study Coordinator will review with subject and complete the checklist for demographics, medical history and previous/concomitant medications.
3. Investigator and/or Study Coordinator will review with subject and complete the checklist for all inclusion and exclusion criteria.
4. Subjects will receive a brief physical exam, including examination of the scalp, to rule out any immediately observable medical issues and scalp disorders that are unacceptable for qualification in accordance with the study exclusion criteria. The physical will additionally include vital signs (blood pressure, heart rate, respiration rate, and temperature), weight and height. Subjects hair thinning will be rated by the Investigator using either the Norwood Scale for men or the Savin Pictorial Scale for women.
5. Subjects who are female of childbearing potential will have a urine pregnancy test performed.
6. Subjects who have completed all the initial paperwork and meet the inclusion/exclusion qualifications (including findings of the physical exam) will be assigned a unique subject number. Subjects will be randomized to a treatment group.
7. Subjects will have Canfield Intellistudio 2-D digital photography of their entire head/hair region to assess overall general hair growth and fullness.
8. Subjects will have two (2) target sites selected and measured by the Investigator.
9. Subjects will have Canfield HairMetrix trichoscopy imaging of the two (2) target site areas taken for hair analysis.
10. Subjects will have a Hair Shedding Pull test in four regions of the hair by the Investigator.
11. Subjects will complete the Hair Thinning Quality of Life Questionnaire.
12. Subjects will be dispensed a three (3) month supply of the Active or Placebo and given written and verbal Usage and Lifestyle instructions.
13. Subjects will be given their next appointment date and time, and instructed to bring back all Study IP, including empty bottles.
Phone Call: Day 56 ± 2 days
1. The Study Coordinator will ask subjects if they have experienced any changes in their health or taken new/adjusted current medications since the last visit. If an AE or SAE is reported, the examining Investigator will be informed and the appropriate forms will be completed.
2. The subjects will be asked about the amount of unused Study IP that they have in their current bottles to determine subject compliance with the protocol and usage instructions. Subjects found to be consistently out of compliance will be reminded of the correct usage instructions. Non-compliance will be noted in the Subject IP Compliance Log.
3. Subjects will be asked a series of hair self-assessment questions and hair thinning quality of life questions. The answers to the questionnaires will be recorded in the subject file by the Study Coordinator.
4. Subjects will be reminded of their next appointment date and time, and instructed to bring back all Study IP, including empty bottles to their next appointment.
Visit 2: Day 90 (± 7 days)
1. The Study Coordinator will ask subjects if they have experienced any changes in their health or taken new/adjusted current medications since the last visit. If an AE or SAE is reported, the examining Investigator will be informed and the appropriate forms will be completed.
2. The unused Study IP will be collected and counted to determine subject compliance with the protocol and usage instructions. Subjects found to be consistently out of compliance will be reminded of the correct usage instructions. Non-compliance will be noted in the Subject IP Compliance Log.
3. The subject will have their weight, blood pressure, heart rate, respiratory rate and temperature monitored and recorded in the source.
4. Subjects will have Canfield Intellistudio 2-D digital photography of their entire head/hair region to assess overall general hair growth and fullness.
5. Subjects will have Canfield HairMetrix trichoscopy imaging of the two (2) target site areas taken for hair analysis.
6. Subjects will have a Hair Shedding Pull test in four regions of the hair by the Investigator.
7. Subjects will have their hair assessed by the Investigator for Hair Growth and Hair Quality.
8. Subjects will complete the Hair Self-Assessment Questionnaire and the Hair Thinning Quality of Life Questionnaire.
9. Subjects will be dispensed a three (3) month supply of the Active or Placebo and given written and verbal Usage and Lifestyle instructions.
10. Subjects will be given their next appointment date and time, and instructed to bring back all Study IP, including empty bottles.
Visit 3: Day 180 (± 7 days)
1. The Study Coordinator will ask subjects if they have experienced any changes in their health or taken new/adjusted current medications since the last visit. If an AE or SAE is reported, the examining Investigator will be informed and the appropriate forms will be completed.
2. The unused Study IP will be collected and counted to determine subject compliance with the protocol and usage instructions. Non-compliance will be noted in the Subject IP Compliance Log.
3. The subject will have their weight, blood pressure, heart rate, respiratory rate and temperature monitored and recorded in the source.
4. Subjects will have Canfield Intellistudio 2-D digital photography of their entire head/hair region to assess overall general hair growth and fullness.
5. Subjects will have Canfield HairMetrix trichoscopy imaging of the two (2) target site areas taken for hair analysis.
6. Subjects will have a Hair Shedding Pull test in four regions of the hair by the Investigator.
7. Subjects will have their hair assessed by the Investigator for Hair Growth and Hair Quality.
8. Subjects will complete the Hair Self-Assessment Questionnaire, Hair Thinning Quality of Life Questionnaire and the Hair Product Subject Satisfaction Questionnaire.
9. Subjects will be compensated for their participation in the study.
Study:
NCT06920758
Study Brief:
Protocol Section:
NCT06920758