A Clinical Trial to Examine the Efficacy of a Dietary Supplement to Improve the Health and Appearance of Hair.

NCT06515496 | Active Not Recruiting

• 1 other identifier: 20413
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. It is a randomized controlled trial with 50 female-at-birth participants experiencing self-perceived hair thinning.

Conditions

Hair Thinning; Hair Shedding

Keywords

Hair growth; Female pattern hair loss; Hair health

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Day 90, and Day 180

Secondary Outcomes (1)

• Improvement in Hair Health Perception

  Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180

Study Arms (2)

Intervention

EXPERIMENTAL

Participants in this arm will take the Scale HLV Clinical Formula Hair Vitamins.

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.

Other: Placebo

Interventions

Scale HLV Clinical Formula Hair Vitamins DIETARY_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.

Intervention

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scale Media Inc: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: March 26, 2024
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)