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

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 Overview

• Status: Active, not recruiting
• Conditions: Hair Thinning; Hair Shedding
• Intervention / Treatment: Dietary supplement: Scale HLV Clinical Formula Hair Vitamins; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Participants in this arm will take the Scale HLV Clinical Formula Hair Vitamins.	Dietary supplement: Scale HLV Clinical Formula Hair Vitamins; 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 Comparator: Placebo; Participants in this arm will take a placebo product consisting of rice flour in vegetable cellulose capsules.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180

Collaborators and Investigators

• Sponsor: Scale Media Inc
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): September 26, 2024
• Study Completion (Estimated): September 26, 2024

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Hair growth; Hair health; Female pattern hair loss
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hair Diseases; Alopecia; Alopecia Areata; Hypotrichosis; Physiological Effects of Drugs; Micronutrients; Vitamins
• Other Study ID Numbers: 20413

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No