HyperpigmentationPhase 3NCT07136766

An 18-week Study to Evaluate a Test Product With a Marketed Prescription Product

A Phase 3 study testing Facial Toner in people with Hyperpigmentation, run by Good Molecules, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the efficacy (ability to produce a desired or intended result) of a topical product (applied to the skin) to improve skin lightness, skin condition and appearance (hyperpigmentation [dark spots], brightness/radiance [healthy vibrant appearance], skin texture [smoothness]) on ]… Read more about this study

Who is it for?: Ages 18 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for: Hyperpigmentation
What is being tested?: Facial Toner
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 49 participants
Where: 1 siteUnited States
Study dates: 10 Sep 2025to 16 Feb 2026
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 75 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Individuals with facial hyperpigmentation and/or melasma.
Individuals willing to use a generic 4% Hydroquinone prescription topical cream up to 10 weeks for the duration of the study.
Individuals willing to refrain from use of other drugs or skincare intended to treat hyperpigmentation, other than study-specific products (prescription drug, test product, SPF 50) for the duration of the study.
Individuals who are able to cooperate with the Principal Investigator and study personnel throughout the duration of the study and are willing to comply with all study procedures, methods, evaluations, and study product use.
Individuals who are able to read, understand and willing to sign an informed consent for this specific study and have completed all site required documentation prior to study enrollment (Registration and Medical History).
Individuals who are able to receive emails on their cellular phones and are capable of completing electronic Informed Consents, Photo Model Releases, and/or Questionnaires on their device.
Individuals willing to be photographed and sign a model release.

Who cannot join

Individuals with known allergies and/or reactions to Hydroquinone.
Individuals currently participating in other clinical studies that are testing a face product.
Individuals with uncontrolled medical condition(s), including dermatological problems, which could put them at risk in the opinion of the Principal Investigator or compromise the study outcome and/or chronic or serious diseases and conditions which would prevent participation in this clinical study such as cancer, AIDS, insulin-dependent diabetes, renal impairment, mental illness, and/or drug/alcohol addiction.
Individuals with a history of melanoma, or a treated skin cancer within the last 5 years.
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 unreliable or unlikely to be available for the duration of the study.

Show all 16Show fewer

Individuals with a history of allergic reactions, skin sensitization and/or known allergies to cosmetic and personal care products/ingredients.
Individuals who are immunocompromised.
Individuals who are employees of VCS, other testing firms/laboratories, consumer product, and/or raw goods manufacturers/suppliers.
Individuals who are unable to communicate or cooperate with the Principal Investigator/study personnel due to language problems, poor mental development, or impaired cerebral function.
Individuals who started hormones within the last three months preceding the commencement of the study.
Individuals who are using oral contraception for less than three months before study commencement or who have changed their contraceptive method within the three months before the Baseline visit or planning to modify their contraception treatment within the duration of the study.
Individuals who have regular salon and/or dermatological procedures that can interfere with study results (Microdermabrasion, Fillers, Facial Peels, etc.) and are not willing to stop throughout the study.
Individuals with facial tattoos and facial piercings (that can't be removed).
Individuals with tattooed/permanent make up (i.e., eyeliner, eyebrows, lip liner, etc.), eyebrow microblading, and/or eyelash extensions.
Individuals who plan to change their hairstyle throughout the course of the study or who wear hair coverings regularly (i.e., wigs, coloring, extensions, etc.).

Trial locations and contacts

1 site in 1 country.

United States1 site

Validated Claim Support
Teaneck, New Jersey, 07666

Other trials in United States

About this study

Official title: An 18 Week Study to Assess the Efficacy of a Test Product Used in Combination With a Currently Marketed Prescription Product

Conditions: Hyperpigmentation
Being tested: Facial Toner, Placebo Toner
Medical subject headings: Hyperpigmentation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Facial TonerDrug
Brightening Toner
Placebo TonerOther
Placebo Control Toner

Study groups in NCT07136766
Study group	Role	What they receive
Test Product	Experimental	Not described Receives: Drug: Facial Toner
Control Product	Sham comparator	Not described Receives: Other: Placebo Toner

What is being measured

The primary outcome is the main question the study is designed to answer.

Skin Lightness (L*)
L* scale (lightness scale 0-100, 0 is black and 100 is white)
Measured: 18 weeks
Erythema (a*)
a* (red/green scale from -80 to 80; negative values are green and positive values are red. The more positive values, more redness)
Measured: 18 weeks

Secondary outcomes (5)

Facial Hyperpigmentation
Analyzed by Expert Grading in a 10-point ordinal scale (0 = positive anchor of uniform, even appearance, and 9 = negative anchor of uneven, discolored, pigmentation present)
Measured: 18 weeks
Facial Skin Texture
Analyzed by Expert Grading in a 10-point ordinal scale (0 = positive anchor of smooth, even surface appearance, and 9 = negative anchor of rough, uneven surface appearance)
Measured: 18 weeks
Facial Brightness/Radiance
Analyzed by Expert Grading in a 10-point ordinal scale (0 = positive anchor of radiant, glowing appearance, and 9 = negative anchor of dull/lackluster)
Measured: 18 weeks
Volunteer's Opinion on Product
Subjective Questionnaire with a Likert-scale (0 - disagree to 4 - agree)
Measured: 18 weeks
Facial Skin Changes Via Images
Facial hyperpigmentation was assessed using the VISIA Complexion Analysis imaging system with Red/Brown (RBX) technology. Standardized frontal facial images were analyzed using automated image-processing software to quantify brown pigmentation features. The VISIA-CR RBX Brown Features score is a numerical, software-generated measurement of detected facial pigmentation rather than a count of individual brown spots. Higher scores indicate greater detected brown pigmentation (worse outcome), while lower scores indicate less pigmentation (better outcome). No theoretical minimum or maximum score has been established for this specific measurement. Results are reported as mean ± standard deviation (SD).
Measured: 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Sep 202516 Feb 2026

First posted22 Aug 2025
Study start10 Sep 2025
Primary completion16 Feb 2026
Study completion16 Feb 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for HyperpigmentationStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 49 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07136766
Sponsor's protocol ID: CS251008
Status last verified: Oct 2026
First submitted: 14 Aug 2025
Last updated: 13 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Baumann L. Skin ageing and its treatment. J Pathol. 2007 Jan;211(2):241-51. doi: 10.1002/path.2098.
PubMed 17200942
Samson N, Fink B, Matts PJ. Visible skin condition and perception of human facial appearance. Int J Cosmet Sci. 2010 Jun;32(3):167-84. doi: 10.1111/j.1468-2494.2009.00535.x. Epub 2009 Nov 3.
PubMed 19889046

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
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Efficacy and Safety of Triple-Combination Cream Plus Microneedling Along With Tranexamic Acid Versus Platelet-Rich Plasma in the Treatment of Moderate-to-Severe Melasma: A Randomized Comparative Study
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COMPARISON OF TOPICAL VITAMIN C VS NIACINAMIDE IN TREATMENT OF MELASMA
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Peutz-Jeghers Syndrome

All Hyperpigmentation trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 18 Week Study to Assess the Efficacy of a Test Product Used in Combination With a Currently Marketed Prescription Product
ClinicalTrials.gov ID: NCT07136766
Acronym / sponsor ID: CS251008
Conditions: Hyperpigmentation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 49 participants (actual)
Lead sponsor: Good Molecules, LLCIndustry (pharma, biotech, devices)
Collaborators: Validated Claim Support
Study start: 10 Sep 2025 (actual)
Primary completion: 16 Feb 2026 (actual)
Study completion: 16 Feb 2026 (actual)
First posted: 22 Aug 2025 (actual)
Results: Posted 13 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Test Product	Experimental	Drug: Facial Toner
Control Product	Sham comparator	Other: Placebo Toner

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Individuals with facial hyperpigmentation and/or melasma.
Individuals willing to use a generic 4% Hydroquinone prescription topical cream up to 10 weeks for the duration of the study.
Individuals willing to refrain from use of other drugs or skincare intended to treat hyperpigmentation, other than study-specific products (prescription drug, test product, SPF 50) for the duration of the study.
Individuals who are able to cooperate with the Principal Investigator and study personnel throughout the duration of the study and are willing to comply with all study procedures, methods, evaluations, and study product use.
Individuals who are able to read, understand and willing to sign an informed consent for this specific study and have completed all site required documentation prior to study enrollment (Registration and Medical History).

Key exclusion criteria (16 listed)

Individuals with known allergies and/or reactions to Hydroquinone.
Individuals currently participating in other clinical studies that are testing a face product.
Individuals with uncontrolled medical condition(s), including dermatological problems, which could put them at risk in the opinion of the Principal Investigator or compromise the study outcome and/or chronic or serious diseases and conditions which would prevent participation in this clinical study such as cancer, AIDS, insulin-dependent diabetes, renal impairment, mental illness, and/or drug/alcohol addiction.
Individuals with a history of melanoma, or a treated skin cancer within the last 5 years.
Individuals who are pregnant, lactating, or planning to become pregnant. Individuals who become pregnant during the study must inform the Principal Investigator immediately.

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
Facial TonerBrightening Toner	Drug	Test Product
Placebo TonerPlacebo Control Toner	Other	Control Product

Primary outcome

Skin Lightness (L*)
Time frame: 18 weeks
L* scale (lightness scale 0-100, 0 is black and 100 is white)
Erythema (a*)
Time frame: 18 weeks
a* (red/green scale from -80 to 80; negative values are green and positive values are red. The more positive values, more redness)

5 secondary outcomes

Facial Hyperpigmentation
Time frame: 18 weeks
Facial Skin Texture
Time frame: 18 weeks
Facial Brightness/Radiance
Time frame: 18 weeks
Volunteer's Opinion on Product
Time frame: 18 weeks
Facial Skin Changes Via Images
Time frame: 18 weeks

Results and safety

Results posted to the registry on 13 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product	24	23
Control Product	25	24

Primary outcome: Skin Lightness (L*)

Time frame: 18 weeks. Mean (Standard Deviation). Unit: L* - units on a scale

Measure	Test Product n = 23	Control Product n = 24
Baseline	50.9 (9.7)	56.1 (7.1)
Week_10	52.6 (9.9)	58.1 (6.6)
Week_18	53.1 (10.0)	58.2 (7.1)

Primary outcome: Erythema (a*)

Time frame: 18 weeks. Mean (Standard Deviation). Unit: a* - units on a scale

Measure	Test Product n = 23	Control Product n = 24
Baseline	10.91 (1.91)	11.08 (1.24)
Week_10	11.0 (1.86)	11.13 (1.71)
Week_18	10.74 (1.78)	10.67 (1.73)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 18 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 23 (0%)	1 of 23 (4.3%)	0 of 23
Control Product	0 of 24 (0%)	1 of 24 (4.2%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17200942Baumann L. Skin ageing and its treatment. J Pathol. 2007 Jan;211(2):241-51. doi: 10.1002/path.2098.
Background: PubMed 19889046Samson N, Fink B, Matts PJ. Visible skin condition and perception of human facial appearance. Int J Cosmet Sci. 2010 Jun;32(3):167-84. doi: 10.1111/j.1468-2494.2009.00535.x. Epub 2009 Nov 3.
Individual participant dataSharing planned: No

Related trials for Hyperpigmentation

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A Single-Center, Open-Label Study to Assess the Efficacy and Tolerability of a Brightening Serum in Skin of Color Patients With Post Inflammatory Hyperpigmentation
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Enrolling by invitationPhase 4
Microneedling-Assisted Metformin, Tranexamic Acid, and Modified Kligman's Formula for Melasma
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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 Phase 3 study testing Facial Toner in people with Hyperpigmentation, run by Good Molecules, LLC 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 7 inclusion and 16 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: finished, as of the sponsor's last update on 13 Oct 2026. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Skin Lightness (L*) (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07136766, which also lists 2 linked publications.

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 13 Oct 2026.