Hair ThinningNCT06515496
A Clinical Trial to Examine the Efficacy of a Dietary Supplement to Improve the Health and Appearance of Hair.
A study testing Scale HLV Clinical Formula Hair Vitamins in people with Hair Thinning and Hair Shedding, run by Scale Media Inc at 1 site in United States.
Trial summary
This study evaluates the efficacy of Scale Media's HLV Clinical Formula Hair Vitamins on the health and appearance of hair, focusing on growth, volume, dullness, overall health, hair shedding, fullness, and strength. Read more about this study
- Who is it for?
- Ages 35 years and older, women only
- Conditions the study is for
- Hair Thinning, Hair Shedding
- What is being tested?
- Scale HLV Clinical Formula Hair Vitamins
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to 26 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female at birth, aged 35+.
- Self-perceived hair thinning and increased hair shedding for at least three months.
- Consistent hair care routine for at least one month prior.
- Willing to maintain hair care routine, diet, and refrain from new vitamins or supplements targeting hair growth during the study.
- Generally healthy without uncontrolled chronic diseases.
Who cannot join
- Hair loss conditions other than female pattern baldness.
- Pregnant, breastfeeding, or trying to conceive.
- Currently taking iron supplements or other hair growth treatments.
- Significant chronic conditions or planned medical procedures that interfere with protocol adherence.
- Recent chemical hair treatments or plans for such treatments during the study.
- Severe allergic reactions to the product's ingredients.
- Recent surgeries, major illnesses, or undergoing chemotherapy/radiotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy of Scale Media's HLV Clinical Formula Hair Vitamins on the health and appearance of hair, focusing on growth, volume, dullness, overall health, hair shedding, fullness, and strength. It is a randomized controlled trial with 50 female-at-birth participants experiencing self-perceived hair thinning.
- Conditions
- Hair Thinning, Hair Shedding
- Being tested
- Scale HLV Clinical Formula Hair Vitamins, Placebo
- Keywords
- Hair growth, Female pattern hair loss, Hair health
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scale HLV Clinical Formula Hair VitaminsDietary supplement
For the first week, participants will take 1 capsule in the morning and 2 capsules in the evening before food. From Week 2 onwards, participants will take 3 capsules daily in the evening before food.
PlaceboOther
For the first week, participants will take 1 capsule in the morning and 2 capsules in the evening before food. From Week 2 onwards, participants will take 3 capsules daily in the evening before food.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants in this arm will take the Scale HLV Clinical Formula Hair Vitamins. Receives: Dietary Supplement: Scale HLV Clinical Formula Hair Vitamins |
| Placebo | Placebo comparator | Participants in this arm will take a placebo product consisting of rice flour in vegetable cellulose capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Hair Shedding
Hair shedding will be measured through hair counts from the at-home comb test and hair health will be evaluated through expert dermatologist grading based on photos provided by participants.
Measured: Baseline, Day 90, and Day 180
Secondary outcomes (1)
Improvement in Hair Health Perception
Participants' perceptions of the product's effect on overall hair health, including volume, dullness, fullness, and strength, will be evaluated through self-reported questionnaires.
Measured: Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start26 Mar 2024
- Primary completion26 Sep 2024 (estimated)
- Study completion26 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hair ThinningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scale Media Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515496
- Sponsor's protocol ID
- 20413
- Status last verified
- Jul 2024
- First submitted
- 17 Jul 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan includes sharing individual participant data (IPD) collected during the study. The data to be shared includes de-identified individual participant data that underlie the results reported in the publication, including text, tables, figures, and appendices.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Examine the Efficacy of a Dietary Supplement to Improve the Health and Appearance of Hair.
- ClinicalTrials.gov ID
- NCT06515496
- Acronym / sponsor ID
- 20413
- Conditions
- Hair Thinning, Hair Shedding
- Keywords
- Hair growth, Female pattern hair loss, Hair health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Scale Media IncIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- 26 Sep 2024 (estimated)
- Study completion
- 26 Sep 2024 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of Scale Media's HLV Clinical Formula Hair Vitamins on the health and appearance of hair, focusing on growth, volume, dullness, overall health, hair shedding, fullness, and strength. It is a randomized controlled trial with 50 female-at-birth participants experiencing self-perceived hair thinning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: Scale HLV Clinical Formula Hair VitaminsParticipants in this arm will take the Scale HLV Clinical Formula Hair Vitamins. |
| Placebo | Placebo comparator | Other: PlaceboParticipants in this arm will take a placebo product consisting of rice flour in vegetable cellulose capsules. |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female at birth, aged 35+.
- Self-perceived hair thinning and increased hair shedding for at least three months.
- Consistent hair care routine for at least one month prior.
- Willing to maintain hair care routine, diet, and refrain from new vitamins or supplements targeting hair growth during the study.
- Generally healthy without uncontrolled chronic diseases.
Key exclusion criteria (7 listed)
- Hair loss conditions other than female pattern baldness.
- Pregnant, breastfeeding, or trying to conceive.
- Currently taking iron supplements or other hair growth treatments.
- Significant chronic conditions or planned medical procedures that interfere with protocol adherence.
- Recent chemical hair treatments or plans for such treatments during the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scale HLV Clinical Formula Hair VitaminsFor the first week, participants will take 1 capsule in the morning and 2 capsules in the evening before food. From Week 2 onwards, participants will take 3 capsules daily in the evening before food. | Dietary supplement | Intervention |
| PlaceboFor the first week, participants will take 1 capsule in the morning and 2 capsules in the evening before food. From Week 2 onwards, participants will take 3 capsules daily in the evening before food. | Other | Placebo |
Primary outcome
Reduction in Hair Shedding
Time frame: Baseline, Day 90, and Day 180
Hair shedding will be measured through hair counts from the at-home comb test and hair health will be evaluated through expert dermatologist grading based on photos provided by participants.
1 secondary outcome
Improvement in Hair Health Perception
Time frame: Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. The plan includes sharing individual participant data (IPD) collected during the study. The data to be shared includes de-identified individual participant data that underlie the results reported in the publication, including text, tables, figures, and appendices.
Related trials for Hair Thinning
Active, not recruitingPhase 3
A Study to Learn About Medicine Called Ritlecitinib in Children Aged Between 6 to 12 Years With Severe Alopecia Areata
Severe Alopecia Areata
RecruitingPhase 2
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (Apeced), Alopecia Areata
Active, not recruitingObservational study
Litfulo Capsules Special Investigation
Alopecia Areata
Active, not recruitingObservational study
Real-World Effectiveness of Ritlecitinib in Alopecia Areata Patients in the US: A Retrospective Analysis Using EHR and Claims Data
Alopecia Areata
Active, not recruitingObservational study
Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
Alopecia Areata
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scale HLV Clinical Formula Hair Vitamins in people with Hair Thinning and Hair Shedding, run by Scale Media Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Hair Shedding (time frame: Baseline, Day 90, and Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.