Cosmetic Formulations for Gray Hair

Overseen By Sarah Paterson

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Unilever R&D

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Cancer, Diabetes, Asthma, Epilepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 90

Duration: 6 months

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how two different cosmetic products, U82 and Z63, might affect the appearance of gray hair. Participants will apply one of these products daily to their entire scalp for six months. It suits individuals with 15% to 35% natural gray hair who can attend all study visits. Researchers aim to determine if these products can visibly alter gray hair, potentially offering new options for managing graying hair. As an unphased trial, this study allows participants to contribute to innovative research that could lead to new solutions for gray hair management.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cosmetic products like U82 and Z63 are generally safe. These products adhere to strict safety regulations. For instance, color additives in cosmetics require approval under the Federal Food, Drug, and Cosmetic Act to ensure safety before use.

A safety report for U82 indicates it is not considered hazardous under OSHA standards. However, it may cause mild skin and eye irritation, so washing hands and skin after use is important.

While specific safety details for Z63 are unavailable, similar products typically undergo checks to ensure they contain safe ingredients. This process includes assessing potential health effects, which helps reduce risks when used as directed.

Overall, both U82 and Z63 are designed for safe daily use on the scalp. Users might experience mild irritation, but serious side effects are not expected. Always follow the instructions to minimize potential issues. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for gray hair focus on temporary color changes using dyes that wash out quickly or semi-permanent colorants that require frequent reapplication. However, cosmetic products U82 and Z63 are unique because they are designed as leave-on scalp treatments applied daily over six months, potentially offering a more lasting approach to managing gray hair. Researchers are excited about these treatments because they might provide a non-dye solution that gradually restores natural hair color by targeting the pigmentation process at the scalp level. This novel approach could offer a long-term solution for those seeking to reduce gray hair without the regular maintenance that traditional dyes require.

What evidence suggests that this trial's treatments could be effective for gray hair?

In this trial, participants will use either cosmetic product Z63 or U82. Research has shown that cosmetic product Z63 may help reduce gray hair. In one study, 64% of people noticed fewer gray hairs after using similar hair serums daily for three months. Another study found that 88% of people using a related product saw less gray hair growth.

Similarly, cosmetic product U82, another treatment option in this trial, might also be effective. Tests showed that 88% of users experienced a decrease in new gray hairs. This suggests that both products could help reduce the appearance of gray hair over time. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

Healthy men and women aged 25-60 with 15-35% naturally gray hair, who can attend all study visits and understand English instructions. Excluded are those allergic to product ingredients or metals, employees of the sponsor/testing facility, individuals with certain medical conditions (like cancer or chronic diseases), recent users of anti-gray hair treatments, those on long-term medications started or changed within the last 6 months, immunological disorder sufferers, blood clotting disorders patients, people with significant hair loss issues or systemic diseases.

Inclusion Criteria

Of any race and ethnicity

I am between 25 and 60 years old.

Has 15 - 35% naturally gray hair

Exclusion Criteria

Individuals that are sensitive/allergic to any of the ingredients in any of the test products adhesives, tattoo pigments/ink, or metals used in needles (i.e., chromium or nickel)

Individuals who are involved in any aspect of administration or an employee of Sponsor or testing facility

Individuals with any relevant past or present medical history which may affect the study results or may lead to increased risk to the participant in the judgement of the Investigator or designee, including a history of cancer, insulin-dependent diabetes, acute or chronic renal insufficiency, chronic inflammatory disorders (arthritis, osteoarthritis, inflammatory bowel disease, colitis, etc.), asthma (not including exercise-induced asthma), epilepsy, uncontrolled hyperthyroidism, or uncontrolled hypothyroidism. Participants who have well controlled hyperthyroidism and hypothyroidism (stable medication for greater than 6 months) will be permitted

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of two cosmetic scalp leave-on products applied daily for 6 months

6 months

Baseline, Day 90, Day 180 (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• U82
• Z63

Trial Overview The trial is testing two cosmetic products named U82 and Z63 over a period of six months to see their effects on reducing the appearance of gray hair. Participants will be randomly assigned one of these products without knowing which one they're using (double-blind).

How Is the Trial Designed?

Group I: Cosmetic product Z63 Experimental Treatment 1 Intervention

Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.

Group II: Cosmetic product U82 Experimental Treatment 1 Intervention

Cosmetic scalp leave on product to be used once daily on the whole scalp for 6 months.

Who Is Running the Clinical Trial?

Unilever R&D

Lead Sponsor

Trials

132

Recruited

34,600+

Headquarters

No specific location for R&D, but Unilever's main headquarters are in London, UK and Rotterdam, Netherlands

Known For

Sustainable Biotech Solutions

Fernando Fernandez

Unilever R&D

Chief Executive Officer

MBA from IESE Business School

Dr. Marie Brueser

Unilever R&D

Chief Medical Officer since 2023

MD from an unspecified institution

Comprehensive Research Group, Inc.

Collaborator

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07280676?aggFilters=status%3A

The Effect of Cosmetic Formulations on the Appearance ... This study is a 6-month (180 days) single-center, double blind study designed to explore the effect of two cosmetic products on the appearance ...

2. trial.medpath.com trial.medpath.com/clinical-trial/30ee581e420d104c/nct07280676-cosmetic-formulations-grey-hair-appearance

The Effect of Cosmetic Formulations on the Appearance of ... This study is a 6-month (180 days) single-center, double blind study designed to explore the effect of two cosmetic products on the appearance ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07123636

A Clinical Study to Assess the Effect of Hair Care Products ... This is a 24-week virtual, single-arm study designed to evaluate the effectiveness of a hair care system-comprising the "Not Today, Grey" ...

4. facebook.com facebook.com/newbeautymagazine/videos/the-wrinkle-cream-of-haircare/1609581296734369/

88% saw a decrease in new grey hair growth. 13% ... After 6 months using Arey's The System: 88% saw a decrease in new grey hair growth. 13% decrease in grey hair growth vs. a 10% increase in ...

5. cosmeticsdesign.com cosmeticsdesign.com/Article/2024/09/25/Arey-s-double-blind-study-challenges-what-s-possible-in-grey-hair-treatment/

'The wrinkle cream of hair care': Arey's double-blind study ... The results showed that 88% of participants using Arey's “The System” saw reduced grey hair growth and experienced three times more thickness, fuller hair, and ...

6. fda.gov fda.gov/industry/color-additives/color-additives-and-cosmetics-fact-sheet

Color Additives and Cosmetics: Fact Sheet Color additives are subject to a strict system of approval under US law [Federal Food, Drug, and Cosmetic Act (FD&C Act), sec. 721; 21 USC 379e].

7. fsd1-sc.safeschoolssds.com fsd1-sc.safeschoolssds.com/document/repo/a0551de2-7d8c-4f6c-9a35-32b67dc635d0

SAFETY DATA SHEET OSHA/HCS status. : While this material is not considered hazardous by the OSHA Hazard Communication. Standard (29 CFR 1910.1200), this SDS ...

8. mydentitycolor.com mydentitycolor.com/wp-content/uploads/2022/08/SDS-All-Shades-Permanent-Hair-Color.pdf

SDS-All-Shades-Permanent-Hair-Color.pdf Hazard Statements (H): H316 – Causes mild skin irritation. H320 – Causes eye irritation. Precautionary Statements (P): P264 – Wash hands and exposed skin ...

9. assets.marlobeauty.com assets.marlobeauty.com/images/graphics/pages/SDS%20Sheets/8242.pdf

One 'N Only Shiny Silver Perm with Argan Oil [Emergency Overview] This is a personal care product that is safe for consumers and other users under intended and reasonably foreseeable use.