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A 4-week Study Investigating Two Targeted Brightening Serum (A and B) Versus 4% Hydroquinone in Women With Mild to Severe Full-face Hyperpigmentation

8. juni 2026 opdateret af: Revision Skincare

A Multi-Center, Randomized, Blinded, Split-Face, Controlled Clinical Study to Assess Two Targeted Brightening Serum (A and B) Paired With 4% Hydroquinone

This a short four-week pilot study to measure the efficacy and tolerance of two brightening serums (cosmetics) versus 4% hydroquinone. The study was conducted in two sites across the USA, one in PA and in one in CA. The goal was to run the pilot study in the summer to understand the role of these two potential brightening serums in helping the appearance of skin tone evenness.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

This is a four-week multi-center, single-blind, randomized, split-face, controlled pilot study conducted to assess the efficacy and tolerance of two pigment correction formulations (Brightening Serum A and Brightening Serum B) compared to 4% Hydroquinone split face when used over the course of 4 weeks by healthy females with clinically determined mild to severe facial hyperpigmentation, including melasma on the global face. Subjects will be randomized into 2 cells which will receive the following split face treatments:

  • Cell 1: Brightening Serum A versus 4% Hydroquinone
  • Cell 2: Brightening Serum B versus 4% Hydroquinone It was hypothesized that the Brightening Serum A and B will produce statistically significant improvements at post-baseline timepoints when compared with baseline, and comparable improvements versus the standard of care 4% Hydroquinone across the primary endpoint, secondary and tertiary endpoints. Additionally, the Sponsor's test materials will be well tolerated by subjects, with no statistically significant increases in scores for tolerability/safety parameters, specifically erythema and dryness, at any study timepoint when compared with baseline scores. Furthermore, the Sponsor's test materials will be well perceived by subjects according to analyses of self-assessment questionnaires, with a statistically significant proportion of favorable responses compared to unfavorable responses and/or a statistically significant improvement in subject response values when compared with baseline.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Texas
      • Irving, Texas, Forenede Stater, 75063
        • Revision Skincare

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • In good general health (physical, mental, and social well-being, not merely the absence of disease/infirmity), according to subject self-report.
  • Having Fitzpatrick skin type I-VI (refer to Appendix I: Fitzpatrick Skin Type)
  • Age 20 to 60 years.
  • Subjects with self-perceived hyperpigmented facial skin
  • Having mild to severe (score of 3-9 according to a modified Griffiths scale,2 where 0 = none, 1 to 3 = mild, 4 to 6 = moderate, 7 to 9 = severe) full-face hyperpigmentation, including melasma. Hyperpigmentation and melasma must present at equal severity and size on each facial side.
  • Willing to maintain visit 1/baseline condition of eyebrows and eyelashes (do not noticeably change brow/lash appearance) during the study.
  • Willing to provide written informed consent and able to read, speak, write, and understand English.
  • Willing to sign a photography release.
  • Having not had any facial treatments in the past 6 months and are willing to withhold all facial treatments during the course of the study including facials, facial peels, photo facials, laser treatments, dermabrasion, botulinum toxin (Botox®), injectable filler treatments, intense pulsed light (IPL), acid treatments, tightening treatments, facial plastic surgery, or any other treatment administered by a physician or skin care professional designed to improve the appearance or firmness of facial skin. Waxing and threading are allowed but not facial laser hair removal.

Exclusion Criteria:

  • Having been diagnosed with known allergies to skin care products.
  • Having a known reactivity to tranexamic acid, niacinamide, sunflower seed, coconut, rosemary, barley, goji, sandalwood, licorice root, radish root, beeswax, yeast, ascorbic acid, tetrahexyldecyl ascorbate, and/or any of the ingredients in the study products.
  • Breastfeeding, pregnant, or planning to become pregnant during the study according to subject self-report.
  • Having a history of skin cancer within the past 5 years.
  • Currently taking oral or topical prescription medications for melasma such as Triluma, compounded hydroquinone, retinoids, and tranexamic acid.
  • Currently using oral or topical prescription medications for acne such as doxycycline, minocycline, clindamycin, bactrim, tetracycline, erythromycin, vibramycin, azelaic acid, benzoyl peroxide, Dapsone, or sodium sulfacetamide.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Brightening Serum A
The brightening serum A is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamoyl Dipeptide-23, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Andet: Facial Cleanser
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Andet: Facial Moisturizer
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Andet: Sunscreen SPF 55
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
Aktiv komparator: Brightening Serum B
The brightening serum B is a hydroquinone-free serum containing botanical ingredients, brightening ingredients such as tranexamic acid, niacinamide, vitamin C, diacetyl boldine, antioxidants and microbiome technology to help reduce skin pigmentation.
Andet: Facial Cleanser
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Andet: Facial Moisturizer
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Andet: Sunscreen SPF 55
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step
Andet: 4% Hydroquinone
This topical 4% hydroquinone cream was applied split-face to side randomized for application.
Andet: Facial Cleanser
Gentle Foaming Cleanser to wash the face two times a day (am/pm)
Andet: Facial Moisturizer
Basic Moisturizer applied in the evening after the treatment (brightening serum a, or b or the 4% HQ).
Andet: Sunscreen SPF 55
Neutrogena Ultra Sheer Dry-Touch Sunscreen SPF 55 applied in the am as the last step

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurement of Clinical Efficacy Parameters by Clinical Grader
Tidsramme: Baseline, week 2, week 4
Clinical grading efficacy parameters measured by blinded clinical grader including skin tone evenness, hyperpigmentation on the global face, and overall appearance. Grading was performed on a 10-point Griffith's scale, where 0 = best possible outcome 9= severe skin condition. A decrease in score/ value indicates an improvement.
Baseline, week 2, week 4

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurement of Global Melasma Severity Assessment Score (GMSA)
Tidsramme: baseline and weeks 2 and 4

The expert grader (Board-Certified Dermatologist) will evaluate the right and left facial side using a Global Melasma Severity Assessment (GMSA) according to the following numerical definitions. Half-point scores may be used as necessary to more accurately describe the skin condition.

0 = clear

  1. = mild
  2. = moderate
  3. = severe
baseline and weeks 2 and 4

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measurement of facial Melasma
Tidsramme: Baseline, week 2 and week 4
The MASI score is a clinical tool used to assess the severity of melasma, a hyperpigmentation disorder, in terms of both area and darkness. It quantifies the extent and intensity of melasma in four facial regions: the forehead (F), right malar region (MR), left malar region (ML), and chin (C), corresponding to 30%, 30%, 30%, and 10% of the total face, respectively. A decrease in score indicates improvement
Baseline, week 2 and week 4
Incidence of Treatment- Emergent Adverse Events
Tidsramme: Baseline, week 2, and week 4
Local cutaneous tolerability was evaluated by assessing the signs and symptoms of the following objective and subjective irritation parameters globally on each subject's face. Objective irritation (clinically graded): erythema, edema, and dryness. Subjective irritation (assessed by subjects): burning, stinging, and itching. Local cutaneous tolerability was evaluated by assessing objective (erythema, edema, and dryness) and subjective (burning, stinging, and itching) irritation parameters globally on each subject's face using a 4-point scale (0 = none to 3 = severe). A decrease in value indicates an improvement.
Baseline, week 2, and week 4

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Revision Skincare

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

11. august 2025

Primær færdiggørelse (Faktiske)

12. november 2025

Studieafslutning (Faktiske)

12. november 2025

Datoer for studieregistrering

Først indsendt

3. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 07242025
  • Revision Skincare, LLC (Andet bevillings-/finansieringsnummer: Revision Skincare, LLC)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Hyperpigmentering

Kliniske forsøg med Facial Cleanser

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