ClinicalTrials.gg
CompletedNCT07136766Updated Oct 13, 2026Results posted

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

A Phase 3 interventional study of Facial Toner and Placebo Toner in Hyperpigmentation, sponsored by Good Molecules, LLC. Completed at 1 site in United States. Open to female participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by Good Molecules, LLC · Phase 3, Interventional, and Treatment

Updated Oct 13, 2026Now CompletedResults posted+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
49
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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 ] the face over a period of eighteen (18) weeks. The data collected may support the company in developing marketing claims for its product.

02

Conditions studied

  • Hyperpigmentation

Browse trials for

03

In context

Hyperpigmentation

127 studies on the registry are indexed under Hyperpigmentation; 28 are open to participants now.

This study's enrollment of 49 is above the median of 32 across 113 interventional studies indexed under Hyperpigmentation.

Browse Hyperpigmentation studies →

Lead sponsor

Good Molecules, LLC is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Individuals with facial hyperpigmentation and/or melasma.
  2. Individuals willing to use a generic 4% Hydroquinone prescription topical cream up to 10 weeks for the duration of the study.
  3. 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.
  4. 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.
  5. Individuals who are able to read, understand and willing to sign an for this specific study and have completed all site required documentation prior to study enrollment (Registration and Medical History).
  6. 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.
  7. Individuals willing to be photographed and sign a model release.

Exclusion criteria

Exclusion Criteria:

  1. Individuals with known allergies and/or reactions to Hydroquinone.
  2. Individuals currently participating in other clinical studies that are testing a face product.
  3. 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.
  4. Individuals with a history of melanoma, or a treated skin cancer within the last 5 years.
  5. Individuals who are pregnant, lactating, or planning to become pregnant. Individuals who become pregnant during the study must inform the Principal Investigator immediately.
  6. Individuals who are unreliable or unlikely to be available for the duration of the study.
  7. Individuals with a history of allergic reactions, skin sensitization and/or known allergies to cosmetic and personal care products/ingredients.
  8. Individuals who are .
  9. Individuals who are employees of VCS, other testing firms/laboratories, consumer product, and/or raw goods manufacturers/suppliers.
  10. 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.
  11. Individuals who started hormones within the last three months preceding the commencement of the study.
  12. Individuals who are using oral 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.
  13. 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.
  14. Individuals with facial tattoos and facial piercings (that can't be removed).
  15. Individuals with tattooed/permanent make up (i.e., eyeliner, eyebrows, lip liner, etc.), eyebrow microblading, and/or eyelash extensions.
  16. 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.).
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
49 participants (actual)

Study arms

  • Experimental
    Test Product

    Drug: Facial Toner

  • Sham comparator
    Control Product

    Other: Placebo Toner

Interventions

  • DrugFacial Toner

    Brightening Toner

  • OtherPlacebo Toner

    Placebo Control Toner

06

What researchers measure

Primary outcomes

  1. Skin Lightness (L*)

    L\* scale (lightness scale 0-100, 0 is black and 100 is white)

    Time frame: 18 weeks

  2. 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)

    Time frame: 18 weeks

Secondary outcomes

  1. 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)

    Time frame: 18 weeks

  2. 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)

    Time frame: 18 weeks

  3. 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)

    Time frame: 18 weeks

  4. Volunteer's Opinion on Product

    Subjective Questionnaire with a Likert-scale (0 - disagree to 4 - agree)

    Time frame: 18 weeks

  5. 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).

    Time frame: 18 weeks

07

Results

Posted Oct 13, 2026

Participant flow

Participant flow — Overall Study
MilestoneTest ProductControl Product
Started2425
Completed2324
Not completed11
Withdrew: Personal11

Outcome measures

PrimarySkin Lightness (L*)

L\* scale (lightness scale 0-100, 0 is black and 100 is white)

Time frame:
18 weeks
Reported as:
Mean · L* - units on a scale
Skin Lightness (L*)
L* - units on a scaleTest ProductControl Product
Baseline50.9 ± 9.756.1 ± 7.1
Week_1052.6 ± 9.958.1 ± 6.6
Week_1853.1 ± 10.058.2 ± 7.1
SecondaryFacial 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)

Time frame:
18 weeks
Reported as:
Mean · Expert Grading - scores on a scale
Facial Hyperpigmentation
Expert Grading - scores on a scaleTest ProductControl Product
Baseline5.7 ± 1.05.8 ± 0.9
Week_105.0 ± 0.95.2 ± 0.9
Week_184.8 ± 1.14.6 ± 0.9
SecondaryFacial 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)

Time frame:
18 weeks
Reported as:
Mean · Expert Grading - scores on a scale
Facial Skin Texture
Expert Grading - scores on a scaleTest ProductControl Product
Baseline5.3 ± 0.85.5 ± 0.9
Week_104.7 ± 0.84.7 ± 0.7
Week_184.6 ± 0.74.8 ± 1.0
SecondaryFacial 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)

Time frame:
18 weeks
Reported as:
Mean · Expert Grading - scores on a scale
Facial Brightness/Radiance
Expert Grading - scores on a scaleTest ProductControl Product
Baseline5.6 ± 0.75.7 ± 1.0
Week_104.6 ± 0.74.4 ± 0.7
Week_184.3 ± 0.84.4 ± 0.7
SecondaryVolunteer's Opinion on Product

Subjective Questionnaire with a Likert-scale (0 - disagree to 4 - agree)

Time frame:
18 weeks
Reported as:
Mean · Likert-scale - units on a scale
Volunteer's Opinion on Product
Likert-scale - units on a scaleTest ProductControl Product
My skin looked brighter after using the routine.2.0 ± 0.72.1 ± 0.8
My skin looked less dull after using the routine.1.9 ± 0.52.0 ± 0.8
My skin looked more radiant (healthy and vibrant) after using the routine.2.0 ± 0.72.1 ± 0.7
My skin looked more youthful (appears young looking) after using the routine.2.3 ± 0.82.4 ± 0.8
My skin tone (overall color of skin) looked more even after using the routine.2.1 ± 0.72.2 ± 0.8
The pores on my face looked less visible after using the routine.2.3 ± 0.72.3 ± 0.8
The dark spots on my face looked lighter after using the routine.2.0 ± 0.52.0 ± 0.8
My skin felt smoother after using the routine.2.0 ± 0.61.9 ± 0.7
My skin felt less oily after using the routine.1.9 ± 0.72.0 ± 0.8
My skin felt softer after using the routine.1.9 ± 0.71.9 ± 0.7
My skin felt tighter after using the routine.2.1 ± 0.72.3 ± 0.7
I noticed a more refined (improved) skin texture after using the routine.2.3 ± 0.92.1 ± 0.7
I noticed less discoloration on my skin after using the routine.2.2 ± 0.72.1 ± 0.8
I noticed fewer blemishes (marks or imperfections on the skin) on my skin after using the routine.2.3 ± 0.92.3 ± 0.7
SecondaryFacial 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).

Time frame:
18 weeks
Reported as:
Mean · Scores on a scale
Facial Skin Changes Via Images
Scores on a scaleTest ProductControl Product
Baseline87.7 ± 23.093.4 ± 19.6
Week_1095.4 ± 29.3104.7 ± 21.1
Week_18100.7 ± 28.5108.1 ± 23.8
PrimaryErythema (a*)

a\* (red/green scale from -80 to 80; negative values are green and positive values are red. The more positive values, more redness)

Time frame:
18 weeks
Reported as:
Mean · a* - units on a scale
Erythema (a*)
a* - units on a scaleTest ProductControl Product
Baseline10.91 ± 1.9111.08 ± 1.24
Week_1011.0 ± 1.8611.13 ± 1.71
Week_1810.74 ± 1.7810.67 ± 1.73

Adverse events

Collected over Up to 18 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Product0/23 (0%)0/23 (0%)1/23 (4.3%)
Control Product0/24 (0%)0/24 (0%)1/24 (4.2%)
Most frequent other events
Most frequent other events
EventTest ProductControl Product
Closed Comedones and PustulesSkin and subcutaneous tissue disorders1/230/24
Right Rotator Cuff RepairMusculoskeletal and connective tissue disorders0/231/24

Baseline characteristics

There is one more participant in the control product group than in the test product group.

Age, Continuous
Age, Continuous(years)Test ProductControl ProductTotal
Mean58.2 ± 8.757.2 ± 8.957.7 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)Test ProductControl ProductTotal
Female232447
Male000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Test ProductControl ProductTotal
Asian246
Black or African American819
Hispanic or Latino347
White101525
08

Study locations

1 site
  • Validated Claim Support
    Teaneck, New Jersey 07666, United States
09

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2025 to primary completion in Feb 2026, 5 months.

Results were first posted in Oct 2026, 7 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2025
First posted
Aug 22, 2025
StartActual
Sep 10, 2025
Primary completionActual
Feb 16, 2026
CompletionActual
Feb 16, 2026
Results first posted
Oct 13, 2026
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Enrolling by invitation→Completed
changed Oct 13, 2026
Results
Results posted
posted Oct 13, 2026
Enrollment
40 (estimated)→49 (actual)
Oct 13, 2026
Primary outcomes
1 edited, 1 added
What changed in the outcomes
  • EditedSkin Lightness (L*)Time frame: 18 weeks
  • AddedErythema (a*)Time frame: 18 weeks
Oct 13, 2026
Documents
Oct 13, 2026
Secondary outcomes
2 edited
What changed in the outcomes
  • EditedVolunteer's opinionOpinion on productProductTime frame: 18 weeks
  • EditedFacial skin changes via imagesSkin Changes Via ImagesTime frame: 18 weeks
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    Enrolling by invitation→Completed
    Results posted
    Documents Study protocol ↗ posted
    Enrollment 40 (estimated)→49 (actual)
    Primary outcomes 1 edited, 1 added
    What changed in the outcomes
    • EditedSkin Lightness (L*)Time frame: 18 weeks
    • AddedErythema (a*)Time frame: 18 weeks
    Secondary outcomes 2 edited
    What changed in the outcomes
    • EditedVolunteer's opinionOpinion on productProductTime frame: 18 weeks
    • EditedFacial skin changes via imagesSkin Changes Via ImagesTime frame: 18 weeks
    + 3 other changes: index terms, verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT07136766
Lead sponsor
Good Molecules, LLC
Collaborators
Validated Claim Support
Responsible party
Sponsor
First posted
Aug 22, 2025
Start date
Sep 10, 2025
Primary completion
Feb 16, 2026
Completion
Feb 16, 2026
Results posted
Oct 13, 2026
Last update
Oct 13, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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