Facial Toner for Hyperpigmentation

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Good Molecules, LLC

Must be taking: Hydroquinone

Disqualifiers: Cancer, AIDS, Diabetes, Renal impairment, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 18 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a facial toner designed to reduce dark spots and improve skin radiance and texture for individuals with facial hyperpigmentation or melasma. Participants will use either the test product or a control product for 18 weeks to assess any noticeable improvement in their skin. The study aims to determine the product's effectiveness and support marketing claims. Ideal candidates have noticeable dark spots and can refrain from using other hyperpigmentation treatments during the trial. As a Phase 3 trial, this is the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

You will need to stop using any drugs or skincare products intended to treat hyperpigmentation, except for the study-specific products. The protocol does not specify other medications, so it's best to discuss your current medications with the study team.

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

Research has shown that the safety of facial toners can vary significantly. Some toners contain strong chemicals and drying ingredients like alcohol, which may irritate the skin. However, details about the specific toner tested in this trial are not available.

Since this trial is in a later stage, the treatment has already undergone testing on people, and any major safety issues have likely been identified. This suggests the treatment is generally safe. Participants might experience mild skin irritation, a common effect with many skin products. Discussing any concerns with the research team before joining the trial is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hyperpigmentation?

Researchers are excited about the facial toner for hyperpigmentation because it could offer a more straightforward and possibly safer alternative to standard treatments like hydroquinone creams, retinoids, and chemical peels. Unlike these options, which often require prescriptions and can cause irritation or peeling, the facial toner is applied simply and may have fewer side effects. Additionally, this toner might work by a unique mechanism that gently evens out skin tone without the harsher effects of other treatments. If successful, it provides a promising new way to address hyperpigmentation with less hassle and discomfort.

What evidence suggests that this facial toner might be an effective treatment for hyperpigmentation?

Research has shown that the facial toner tested in this trial can lighten dark spots and brighten skin. In an earlier study, 76% of participants noticed their brown spots were lighter and less visible after just two weeks. Additionally, 88% saw their skin become brighter and more radiant. Another study found that products containing niacinamide, an ingredient in the toner, can lower melanin levels, which cause dark spots. These results suggest that the facial toner could effectively improve skin tone and reduce dark spots. Participants in this trial will receive either the test product or a control product for comparison. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with hyperpigmentation who want to test a new facial toner against a placebo. Participants should be willing to apply the product as directed and attend follow-up visits. Specific inclusion or exclusion criteria are not provided, but typically involve age, skin type, and no use of conflicting treatments.

Inclusion Criteria

I am willing and able to follow all study instructions and procedures.

I have dark patches on my face or melasma.

Individuals willing to be photographed and sign a model release

Exclusion Criteria

Individuals who are pregnant, lactating, or planning to become pregnant. Individuals who become pregnant during the study must inform the Principal Investigator immediately

Individuals who are immunocompromised

Individuals who are employees of VCS, other testing firms/laboratories, consumer product, and/or raw goods manufacturers/suppliers

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply the topical product to improve skin lightness, condition, and appearance over 18 weeks

18 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Facial Toner

Trial Overview The study compares a new facial toner designed to lighten dark spots and improve overall skin appearance with a placebo over 18 weeks. The goal is to see if the test product can enhance skin brightness, texture, and condition better than the placebo.

How Is the Trial Designed?

Group I: Test Product Experimental Treatment 1 Intervention

Group II: Control Product Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Good Molecules, LLC

Lead Sponsor

Validated Claim Support

Collaborator

Trials

1

Recruited

40+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297970/

An Open‐Label Study Assessing the Efficacy and ... 22%). By Week 2, subjects reported lighter, less noticeable brown spots (76%), brighter, more luminous skin (88%), more even skin tone ( ...

2. preprints.org preprints.org/frontend/manuscript/c4d637ca51e97bdaf1ef9061c0791588/download_pub

Facial Toner Containing 2% Arbutin and 3% Niacinamide ... Similarly, a moisturizer with 5% Niacinamide has been clinically shown to reduce melanin levels in hyperpigmentation and signs of aging by ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10544009/

12-Week, Single-Center Study of a Targeted Pigment ... Results. Dark Spot Treatment improved overall hyperpigmentation, skin tone evenness, and dark spot intensity and contrast at Weeks 2 through 12, ...

4. jaad.org jaad.org/article/S0190-9622(12)01379-5/fulltext

Efficacy of a new lightening skin care routine on facial ... There was a significant improvement in skin radiance (+1.19 and +2), texture, and roughness with both treatments, with a statistically significant difference in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2666328724000385

Original article A randomized, controlled, split-face, double ... This study demonstrates that ABT is effective, safe, and preferred over 4% HQ in individuals with moderate to severe facial hyperpigmentation, including melasma ...

6. annmariegianni.com annmariegianni.com/the-dangers-of-conventional-toner/?srsltid=AfmBOoqyJOcBQ2PNVs6PgCP1VF6bEwu-ud-bYjQUf_nf4S685HLao8QS

The Dangers Of Conventional Toner Conventional toners are typically brimming with harsh chemicals, carcinogens, phthalates, irritants, parabens, and drying additives such as alcohol and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8884185/

Skin Changes and Safety Profile of Topical Products During ... Safety profile data of topical products are either difficult to be obtained or not listed comprehensively in single reference guideline.6 Therefore, the ...

8. vinmec.com vinmec.com/eng/blog/why-does-the-skin-darken-when-using-hydroquinone-en

Why does Hydroquinone cause hyperpigmentation after ... Hydroquinone is an organic compound that is highly effective in lightening the skin. They make skin whiten and treat hyperpigmentation in the skin.

9. mdpi.com mdpi.com/2076-3417/12/6/3177

Spreading of Dangerous Skin-Lightening Products as a ... This article concisely discusses the reasons for the current prevalence of skin lightening products and provides an overview of the skin lightening agents that ...

10. koreancosmetics.cy koreancosmetics.cy/toxic-ingredients-in-facial-toners-a-complete-guide-to-avoid-them/

Toxic Ingredients in Facial Toners: A Complete Guide to Avoid ... We aim to guide you through this essential aspect of skincare while helping you buy authentic, safe, and effective facial toners.