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OpenTrials
Enrolling by Invitation

NCT Number: NCT07136766

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

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.

Enrolling by Invitation

Interested in participating?

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Validated Claim Support

Teaneck, New Jersey, 07666, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.).

Treatment and study plan

Facial Toner

Drug

Brightening Toner

Placebo Toner

Other

Placebo Control Toner

Primary outcomes

  1. Skin Lightness

    Time frame: 18 weeks

    L* and Individual Typology Angle

Secondary outcomes

  1. Facial Hyperpigmentation

    Time frame: 18 weeks

    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)

  2. Facial Skin Texture

    Time frame: 18 weeks

    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)

  3. Facial Brightness/Radiance

    Time frame: 18 weeks

    Analyzed by Expert Grading in a 10-point ordinal scale (0 = positive anchor of radiant, glowing appearance, and 9 = negative anchor of dull/lackluster)

  4. Volunteer's opinion on product

    Time frame: 18 weeks

    Subjective Questionnaire

  5. Facial skin changes via images

    Time frame: 18 weeks

    Photo analysis acquired via Visia CR Imaging

Sponsors and collaborators

Lead sponsor

Good Molecules, LLC

Industry

Collaborators

  • Validated Claim Support

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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